Entries tagged with “recruiter” from BiotechPharmJobs.com

Job Title: Reagent Manufacturing Associate
Company: Luminex Corporation
Location: Madison, WI
Job Type: Full-Time

The Luminex Corporation seeks a Reagent Manufacturing Associate for its Madison, WI office.

Responsibilities:
• Deliver manufacturing requirements and attainment of production schedule for standard inventory, build-to-order, and contract manufacture market products
• Deliver manufacturing requirements for qualification/processing of incoming materials, production intermediates, and stability samples
• Deliver timely and accurate completion of manufacturing sections of process documentation and related business system transactions
• Manufacture of finished goods and in-process reagents under approved documentation
• Deliver timely and accurate completion of inventory cycle counts
• Document non-conformances
• Support design transfer and integration of new products and processes
• Support process development and process improvement projects
• Support investigations and resolution of findings impacting the Reagent Manufacturing Organization identified through audits, non-conformances, corrective/preventive actions, or customer complaints escalation
• Deliver timely maintenance and calibration of assigned Manufacturing measuring and monitoring devices
• Monitor select non-inventory supplies, maintain focused supplies, and generate purchase requisitions as needed
• Maintain cleanliness and integrity of manufacturing laboratory and storage areas
• Participate in applicable departmental and interdepartmental training; maintain current and effective training to standard operating procedures, work instructions, and applicable changes affecting the Reagent Manufacturing
• Assist in establishing annual performance goals; fulfill performance goals
• Maintain effective and professional multi-level organizational interfaces
• Maintain personal compliance and facilitate departmental compliance with the Quality System
• Adhere to safety, disposal, and gowning requirements
• Accurately completeall required documentation for production of quality controlled products including the use and calibration of laboratory equipment and laboratory notebooks for process development projects
• Other related duties as assigned.

Requirements:
• Learning on the Fly--learns quickly/open to change
• Organizational Agility--knows how to go through the proper channels to get things done
• Peer Relationship--cooperative, team player, trusted and supported by peers
• Planning--sets specific goals and objectives, ability to plan for the length and difficulty of assignments, ability to break down projects into specific tasks/steps
• Priority Setting--focuses on what is most important
• Written Communications--effectively communicates in writing

Required Education/Training:
• Minimum Associate's degree in chemistry, biochemistry or biological/natural sciences or more than 4 years related experience and/or training

Required Certifications/License/Special Skills:
• Highly organized with proven time management and prioritization skills
• High degree of attention to detail
• Ability to work independently and with minimal supervision
• Ability to handle the pressure of meeting tight deadlines
• Excellent interpersonal, verbal and written communication skills

Required Work Experience:
• Experience with equipment and data analysis methods used in a chemistry laboratory
• Experience with calibrated balances, pH meters
• Experience working independently in a fast-paced environment with rapidly changing priorities
• Experience in a GMP and/or FDA regulated environment is preferred

Working Conditions:
• Must work onsite at Luminex office
• Travel may be required approximately
• Possible exposure to biological or chemical hazard
• Work situations include dealing with people; working alone; and making judgments and decisions
• Relevant combinations of education, experience, training, and merit may be considered upon the review of Senior Director of Operations

Physical Requirements:
• Lifting/Use of Strength
• Climbing on the job is required
• Kneeling on the job is required
• Reaching on the job is required
• Stooping on the job is required
• Vision (Color) on the job is required

To apply online, please click here.

An equal opportunity employer, M/F/D/V.

Please reference BioTechPharmJobs.com when responding.

Job Title: Regulatory Affairs Associate
Company: Luminex Corporation
Location: Madison, WI
Job Type: Full-Time

The Luminex Corporation in Madison, WI seeks a Regulatory Affairs Associate to assist with development, management and implementation of regulatory strategies to support rapid entry into new markets upon development of new products and to maintain existing products. The Regulatory Affairs Associate develops US FDA, Health Canada and EU regulatory submissions and ensures timely regulatory filings and documentation processes including technical files.

Responsibilities:
• Prepare 510(k)s, letters/justifications to file, Investigational Device Exemption (IDE), Pre-Market Approval (PMA) Applications, PMA supplements and annual reports for both IDE and PMA as needed for Class I, II and III medical devices
• Assist as needed in preparation, review and submission of international regulatory submissions, product registrations and technical dossiers to Notified Bodies and Health Canada
• Prepare appropriate documentation for product CE mark certification
• Maintain regulatory documentation, registrations and device listings for both domestic and outside the US (OUS). Maintain international regulatory submission technical files, registrations/licenses, device listings and design dossiers for CE marking, and those required for Canada and other international countries outside the US.
• Interacts effectively with functional business units in order to facilitate documentation requirements for submissions, ensuring that departmental timelines are met. Communicate and coordinate regulatory activities with other departments
• Assists in preparation and evaluation of regulatory documents and company specific SOP's to maintain FDA QSR & ISO 13485 compliance
• Provide appropriate regulatory guidance to research and operations staff
• Review and provide input to device labeling and advertising materials for compliance with FDA submissions and applicable regulations
• Review of product and manufacturing changes and compliance with applicable regulations
• Review of protocols and reports to support regulatory submission and product changes
• Participates on interdepartmental teams where required, including design control, FMEA, design and process validation, and associated documentation including written regulatory assessments for inclusion into the Design History Files
• Participate in compliance activities that relate to the department and the company as a whole
• Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies
• Write/revise departmental SOPs as required
• Other duties as required

Requirements:
• Learning on the Fly--learns quickly/open to change
• Organizational Agility--knows how to go through the proper channels to get things done
• Peer Relationship--cooperative, team player, trusted and supported by peers
• Planning--sets specific goals and objectives, ability to plan for the length and difficulty of assignments, ability to break down projects into specific tasks/steps
• Priority Setting--focuses on what is most important
• Written and Oral Communications--effectively communicates verbally and in writing

Required Education/Training:
• Bachelor's Degree in scientific field such as Biochemistry, Medical Technology, Chemistry, Biology
• 3+ years of industry experience in Regulatory Affairs or Quality Assurance Systems within in medical device industry, in vitro medical devices preferred
• RA and/or CRA certification a plus

Required Certifications/License/Special Skills:
• General knowledge of FDA submissions requirements and terminologies (Pre-IDE's, IDEs, 510k and PMA)
• Excellent organizational and project management skills with strong attention to detail
• Independent and self-directed individual
• Successful experience working with cross-functional teams
• Effective written and verbal communication and technical writing skills
• Strong skills and knowledge of corporate software tools -- Microsoft Office Suite including Word, Excel, Power Point.

Required Work Experience:
• Experience working independently in a fast-paced environment with rapidly changing priorities
• Experience as a Technician/Scientist or related biological discipline not required but considered an asset
• Experience in a GMP and/or FDA regulated environment, medical device industry or equivalent
• Experience working independently in a fast-paced environment with rapidly changing priorities
• Multi-task oriented and organized to work within numerous systems and functions
• Work cooperatively in a team environment

Working Conditions:
• Must work onsite at Luminex office
• Travel may be required
• Work situations include dealing with people; working alone; making judgments and decisions
• Limited travel (up to 15-20% of the time, or as circumstances dictate)

Physical Requirements:
• Lifting/Use of Strength is Sedentary (up to 10 pounds)
• Climbing on the job is required: Kneeling on the job is required
• Reaching on the job is required: Never -- This job does not require the demand
• Stooping on the job is required: Never -- This job does not require the demand
• Vision (Color) on the job is required: Occasionally -- up to 33% of the time

To apply online, please click here.

An equal opportunity employer, M/F/D/V.

Please reference BioTechPharmJobs.com when responding.

Job Title: Analytical Program Lead
Company: Merck
Location: Union, NJ
Job Type: Full-Time

Merck, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Position Overview:

The successful candidate will provide scientific and strategic leadership for Biologics programs in development and provide appropriate support to programs in late stage clinical development. This candidate will facilitate the progression of programs from Discovery through late-stage clinical development, with a focus on analytics and the development of appropriate quality control strategies.

In this position, the candidate will be expected to oversee and align the analytical strategy across multiple project teams, implement consistent specification strategies, monitor the implementation of best practices, communicate overall analytical timelines and develop program-specific analytical risk assessments. The candidate should have strong cross-functional coordination and communication skills.

Required:
• BS with a minimum of 7 years' experience in the pharmaceutical industry, or a Masters with 5 years of experience, or a PhD with 3 years' experience.
• In-depth understanding of Biologics development processes
• Strong cross-functional communication skills

Preferred:
• A minimum of 5 years' experience in complex product characterization of Biologics
• Experience in managing programs in setting phase-specific release and stability specifications
• Experience in writing regulatory submissions.

Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.

To be considered for this position, please Apply Here

Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations.

Please reference BioTechPharmJobs.com when responding.

Job Description:

Job Title: Sales - Specialty Chemicals for Life Sciences
Location: San Francisco, CA
Company: Doe & Ingalls
Job Industry: Biotechnology
Job Industry: Specialty Chemical Sales
Job Type: Full-Time
Travel Required: 25-50%

Doe & Ingalls, a part of Thermo Fisher Scientific Production Chemical Sales, Life Sciences, is seeking a Sales - Specialty Chemicals for Life Sciences for its San Francisco, CA location.

The Account Manager is responsible for managing existing customers and developing new business for the life sciences product lines and chemical management services in the Northern California territory.

Key duties and requirements:

• Manage and grow existing accounts with manufacturers in the pharmaceutical, medical device and environmental industry offering process materials, chemicals, and associated chemical management services
• Requires a strong understanding of the pharmaceutical industry to be able to serve as a resource for our customers and effectively present information to engineers, managers and purchasing agents
• Bachelor's Degree or equivalent experience in appropriate specialty (preference for Chemistry, Biochemistry)
• 3 or more years of proven business development, sales and closing experience
• Willingness and availability to travel overnight up to 50% to visit customers, supplier facilities, and attend trade shows

Apply Here: http://www.Click2Apply.net/m6qdg2v

Doe & Ingalls is an Equal Opportunity and Affirmative Action Employer. Any application for employment will be considered active for 30 days or until the position is filled, whichever comes first.

Please reference BioTechPharmJobs.com when responding.

Job Description:

Job Title: Sales - Specialty Chemicals for Life Sciences
Location: Riverside, CA
Company: Doe & Ingalls
Job Industry: Biotechnology
Job Industry: Specialty Chemical Sales
Job Type: Full-Time
Travel Required: 25-50%

Doe & Ingalls, a part of Thermo Fisher Scientific Production Chemical Sales, Life Sciences, is seeking a Sales - Specialty Chemicals for Life Sciences for its Riverside, CA location.

The Account Manager is responsible for managing existing customers and developing new business for the life sciences product lines and chemical management services in the Southern California territory.

Key duties and requirements:

• Manage and grow existing accounts with manufacturers in the pharmaceutical, medical device and environmental industry offering process materials, chemicals, and associated chemical management services
• Requires a strong understanding of the pharmaceutical industry to be able to serve as a resource for our customers and effectively present information to engineers, managers and purchasing agents
• Bachelor's Degree or equivalent experience in appropriate specialty (preference for Chemistry, Biochemistry)
• 3 or more years of proven business development, sales and closing experience
• Willingness and availability to travel overnight up to 50% to visit customers, supplier facilities, and attend trade shows

Apply Here: http://www.Click2Apply.net/7d9znqs

Doe & Ingalls is an Equal Opportunity and Affirmative Action Employer. Any application for employment will be considered active for 30 days or until the position is filled, whichever comes first.

Please reference BioTechPharmJobs.com when responding.

Job Title: Clinical Data Analyst
Location: Rockville, MD
Company: OMNITEC Solutions, Inc.
Job Industry: Computer Software
Travel Required: 0-10%
Job Type: Full-Time


OMNITEC Solutions, Inc. is looking for a Clinical Data Analyst to join our team in Rockville, MD with the leading the National Database for Autism Research. We are leading the effort to make all autism research available through a single portal at the National Institutes of Health (NIH). See http://ndar.nih.gov for more information.

Responsibilities:

• Help lead the autism bioinformatics community by making rich research data easily available to scientists seeking to gain a better understanding of autism
• Focus on data harmonization, database organization & effectiveness, and informatics in dealing with research data that has been gathered and then disparately stored by other Researchers
• Utilize your clinical data analysis & management, and database skills to ensure all data is accessible and useful to a broad audience

Requirements:

• A four-year degree is preferred, along with 5+ years experience managing clinical, imaging, and genomics research data in a complex informatics environment is needed
• Excellent verbal and written communication skills, as well as a strong understanding of databases and database programming concepts are required
• Oracle expertise is a plus

To apply, please send your MS Word resume and reference job code 11.0066.MD along with your replies to the items below to: employment@omnitecinc.com

1. You must be authorized to work in the United States; Please indicate if you are a US citizen or holder of an authorized green card
2. Please provide brief comments regarding your past experience with data harmonization, database organization & effectiveness, and informatics
3. Please provide brief comments on which databases and related tools you are most skilled with
4. Please provide brief comments regarding any past experience supporting Bioinformatics and/or Healthcare research efforts
5. Please provide 2-3 comments on why you feel you are a good match to this opportunity
6. What is your salary requirement?
7. Please tell us how to became aware of this employment opportunity. Thank you!

OMNITEC Solutions, Inc. is an Equal Opportunity Employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.

Online universities have information on biotech degrees for those who want to further educate themselves.

Job Description:

Job Title: Warehouse Specialist
Location: Danvers, MA
Company: Doe & Ingalls
Job Industry: Biotechnology
Job Type: Full-Time


Doe & Ingalls is looking for a Warehouse Specialist for its Danvers, MA location.

Responsibilities:

• Performs material handling required to complete receiving, storage, picking, and shipping operations
• Performs receiving inspections of inbound shipments and stores products in designated warehouse locations
• Performs order picking functions and prepares orders for shipment including required inspections of sales order and shipping manifest
• Performs required warehouse and warehouse equipment maintenance and housekeeping requirements as directed by the Site Manager
• Learns and executes ISO 9001 Quality System Procedures and Work Instructions related to this position's duties and responsibilities

Requirements:

• High School diploma or equivalent
• Physical ability to perform materials handling responsibilities
• 2 years Warehouse/Materials Handling experience highly desirable
• HAZMAT shipping experience desirable
• Forklift experience and must become forklift certified within 30 days

To apply, please send your MS Word resume along with salary requirements by applying online at:
http://www.Click2Apply.net/xcnh5hr

Doe & Ingalls is an Equal Opportunity and Affirmative Action Employer. Any application for employment will be considered active for 30 days or until the position is filled, whichever comes first.

Please reference BioTechPharmJobs.com when responding.

Job Description:

Job Title: Account Manager, Life Sciences
Location: Tampa, Florida
Company: Doe & Ingalls
Job Function: Sales
Job Industry: Biotechnology
Job Type: Full-Time
Travel Required: up to 50%

Doe & Ingalls is looking for an Account Manager, Life Sciences for its Tampa, FL location.

Responsibilities:

• Manage existing customers and develop new business for the life sciences product lines and chemical management services throughout Florida
• Manage and grow existing accounts with manufacturers and laboratories in the pharmaceutical, medical device and environmental industry offering process materials, laboratory chemicals, and associated chemical management services

Requirements:

• A strong understanding of the pharmaceutical industry to be able to serve as a resource for our customers and effectively present information to engineers, managers and purchasing agents / managers
• Bachelor's Degree or equivalent experience in appropriate specialty (preference for Chemistry, Biochemistry)
• 3 or more years of proven business development, sales and closing experience
• Willingness and availability to travel overnight up to 50% to visit customers, supplier facilities, and attend trade shows

To apply, please send your MS Word resume along with salary requirements by applying online at:
http://www.Click2Apply.net/jhsddvf

Doe & Ingalls is an Equal Opportunity and Affirmative Action Employer. Any application for employment will be considered active for 30 days or until the position is filled, whichever comes first.

Please reference BioTechPharmJobs.com when responding.

Job Description:

Job Title: Quality Specialist - cGMP
Location: Durham, NC
Company: Doe & Ingalls
Job Function: Quality Assurance
Job Industry: Biotechnology
Job Type: Full-Time
Experience Required: 2-3 Years
Education Required: BA/BS/Undergraduate
Travel Required: 10-25%

Doe & Ingalls is looking for an Quality Specialist - Specialty Chemicals for its Durham, NC location.

Responsibilities:

• Executing the daily sampling activities to meet and exceed our customer requirements for safe, accurate, and cGMP compliant raw material sampling
• Work closely with customer quality and materials management personnel to implement and execute a raw material sampling program
• Support the facility-based and corporate functions of the Quality Systems Department such as document control, records management, CAR/PAR processing, customer audit support, internal auditing, and training, etc.
• Coordinate with the Site Manager and warehouse staff to execute the materials movement and other warehouse activities needed to support the raw material sampling processes
• Clean, stock and maintain the raw material sampling area, equipment and instruments • Write and follow standard operating procedures related to the raw material sampling function.

Requirements:

• Bachelor's Degree in Chemistry or related science or equivalent experience in appropriate specialty
• Minimum of 2 years experience in a cGMP controlled environment such as biopharmaceutical manufacturing, raw material sampling, environmental monitoring and/or quality assurance.

To apply, please send your MS Word resume along with salary requirements by applying online at:
http://www.Click2Apply.net/zsqq53b

Doe & Ingalls is an Equal Opportunity and Affirmative Action Employer. Any application for employment will be considered active for 30 days or until the position is filled, whichever comes first.

Please reference BioTechPharmJobs.com when responding.

Job Description:

Job Title: Automation Engineer
Location: Bothell, WA
Company: Ricerca Biosciences LLC

Customers count on Ricerca to help them bring much-needed new drugs to market - and to increase their speed, precision and productivity along the way. Ricerca Biosciences applies advanced scientific and technological expertise to the drug discovery and development process. We are looking for an Automation Engineer reporting to the Senior Manager of Operations.

Responsibilities:
• Responsible for the use and performance of the automated systems in order to execute large and small-scale R&D or client projects along with responsibilities for assay workflow testing, validation and implementation
• Works closely with laboratory personnel to accomplish project objectives
• Participates as a member of project teams to design new processes, or to evaluate new technologies

Essential Functions:
• Run established assays on the automation systems and/or assist end-users running established assays
• Integrate new equipment
• Develop, validate and implement new automation protocols
• Communicate with lab staff and scientists, in order to understand the needs and requirements of the scientific teams
• Maintain and troubleshoot automation equipment, including routine maintenance and periodic quality control testing
• Perform a variety of support functions
• Enter information into logs of equipment utilization, maintenance or errors, track reagent use and supply, maintain files on suppliers, writing SOPs and protocols, etc.
• Participate in project groups developing and/or evaluating new technologies and processes

Requirements:
• 2+ years industry experience in lab automation
• B.S. in biological science, engineering, or related field
• Hands-on experience with articulated robotic arms, liquid handling workstations, liquid dispensers, plate washers, plate readers, incubators, and automation scheduling software
• Experience with in vitro and cell-based assay techniques
• Computer programming experience a plus V11 experience a plus

To apply, please apply online to:
http://www.Click2Apply.net/2dnjt9q

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.

Job Description:

Job Title: Strategic Planning Pharma Manager
Location: Tarrytown, NY
Company: The NMS Group

The NMS Group is looking for a Strategic Planning Pharma Manager for its Tarrytown, NY office.

Responsibilities:

• The primary responsibility of this position is to be accountable for the strategy development, key strategic project management, and process design for the Strategic Planning and Analysis Group
• Individual will conduct research, perform supply chain analysis and problem solving relative to establishing strategic supply chain direction as well as optimization of current Product Supply SAP SCM planning tools, inventory, forecasting, planning, and scheduling processes
• Document current supply chain network and perform analysis on optimization opportunities
• Accountability includes supply chain direction setting, management of cost savings initiatives and metrics, measurement and benchmarking for Global Product Supply
• Analyze, plan, and implement on assigned DC Product Supply projects providing management with accurate and relevant information to make effective decisions in response to product supply issues or opportunities
• Recommends strategies and actions based on analysis
• Lead the design, implementation, and standardization of global strategic projects across multiple areas supporting DC PS requirements and organization objectives: supply chain network, sourcing, planning tools, process redesign
• Lead the design, implementation, and standardization of global strategic projects across multiple areas supporting DC PS requirements and organization objectives: supply chain network, sourcing, planning tools, process redesign
• Identify, redesign and implement process enhancements / improvements supporting Sales and Operations Planning, inventory management, forecasting and sourcing, new product development and other areas
• Identify and recommend research projects in areas of responsibility to help optimize growth opportunities and support Product Supply strategic direction
• Collaborate with PS stakeholders to extract requirements, develop plans, timelines, reporting and metrics for specific PS projects
• Serve as Product Supply due diligence team member to support Business Development as required
• Acquire and maintain knowledge of industry trends and professional practices and techniques within areas of responsibilities
• Support Product Supply planning systems across PS organization
• Identify problems/opportunities, as well as recommending solutions to problems identified by management

Requirements:

• Knowledge of consumer products manufacturing, Supply Chain strategies projects and problem solving
• Experience in medical device or similar industry
• Experience working in a global role
• Experience in Supply Chain strategy and process design in both industry and consulting roles
• Experience working with SAP, including implementation and network optimization analysis
• Masters Degree preferred
• Candidate must have a Bachelors Degree with 7 - 10 years experience

To apply, please send your MS Word resume along with salary requirements to:
barnett@nms-group.com

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.

Job Description:

Job Title: Regulatory Affairs Director
Location: Boise, ID
Company: J.R. Simplot Company


The J.R. Simplot Company is looking for a a Regulatory Affairs Director for its Boise, ID headquarters.

Responsibilities:

• Develop and implement a regulatory strategy, in addition to lead efforts for approval of biotech products in the U.S., Canada, Mexico, Japan and other countries as needed for export and trade protection
• Interface and communicate with U.S. and International Governmental Regulatory agencies to ensure the smoothest path through regulatory for Simplot and Simplot partner biotechnology products
• Work closely with the R&D director and other Research Scientists to plan and execute all studies needed for regulatory approval
• Hire and manage regulatory consultants who specialize in obtaining approval in each of the countries
• Develop and oversee quality systems for managing successful market launches of biotech potatoes both domestically and internationally
• Collaborate with biotech researchers to influence regulatory agencies regarding the product safety with the goal of minimizing time and resources needed for approval

Requirements:

• 10 years related experience and/or training
• 5 years of practical experience in the field of plant biotechnology
• Requires 10 years relevant experience in the industry, with at least 5 yrs in biotechnology regulatory role
• Background in quality systems, project management, statistics, potato growing practices, plant biology, government regulations, and food processing desired
• Experience working for National level regulatory agencies desired
• Knowledge and experience in molecular biology is required, and knowledge of plant physiology and/or genetics is desirable
• Experience in the area of biotechnology is also desirable
• A proven track record of developing dossiers for approval of biotech plants by US and International agencies would be ideal
• A background in biological sciences with enough technical depth to understand and explain dossiers to regulatory agencies
• Strong verbal and written communication skills and a practical understanding of U.S. and International regulations for biotech products
• Knowledge and use of negotiation skills through executed agreements and collaborative research
• Candidates must excel at working collaboratively with other groups at Simplot and with external colleagues and partners
• This individual must be a self-starter, willing to work with minimal direction
• 25% travel required

Education:

• B.S. (M.S. or PhD preferred) in the Sciences, which could be from Molecular Biology, Biochemistry, Genetics, Plant Physiology, Engineering, or other relevant majors
• The ideal candidate would have an advanced degree and at least 10 years relevant industry experience, including 5 years in biotech regulatory

To apply, please send your MS Word resume along with salary requirements to:
kayce.mcewan@simplot.com

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.

Online masters degree programs are an option for people who realize that the job they want requires advanced education.

Job Description:

Job Title: Animal Technician
Location: Cambridge, MA
Company: Radiant Info Systems
Contract: Duration: 12 months

Radiant Info Systems is looking for an Animal Technician for its Cambridge, MA office.

Responsibilities:

• Review, comprehend and comply with all SOP's and internal guidelines
• Perform daily health observations and communicate issues as appropriate
• Perform husbandry duties for rats and mice
• Perform cagewash and preparation activities to include usage of equipment and maintenance of adequate inventories
• Perform monthly census, handle related documentation and follow reporting procedures
• Utilize internal databases to assist in the receipt and processing of supplies
• Perform general housekeeping and adhere to safety procedures
• Performs other duties as assigned

Requirements:

• Minimum of 1-3 years directly related experience
• AALAS certification is preferred
• Good working knowledge of Microsoft Word and Excel
• Strong organizational skills and attention to detail
• Strong written and verbal English communication skills
• Ability to follow written and verbal instructions
• Ability to stand for extended periods of time
• Ability to regularly lift/push, or pull up to 50 pounds

Other:

• Regular work schedule is 40 hours per week; however, the incumbent may be required to work on weekends and holidays on a rotating basis
• This position is overtime eligible

To apply, please send your MS Word resume along with salary requirements to:
SPalakurthi@radiants.com

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.

Job Description:

Job Title: Staff Analyst - Statistical Programming
Location: Cambridge, MA
Company: Radiant Info Systems
Contract: Duration: 6 months

Radiant Info Systems is looking for a Staff Analyst - Statistical Programming for its Cambridge, MA office.

Responsibilities:

• Supports statistical programming activities in the production of the analysis datasets, tables, listings, figures, electronic submission components, and complex ad hoc analyses
• Monitors and meets assigned study and program milestones and requests resources as needed
• Leads a small team of support statistical programmers to accomplish tasks and communicate issues to senior management as necessary
• Provides input to policy, operations, and capability building in Statistical Programming and Operations
• Leads cross-functional teams to implement policy, operations, and capability initiatives
• Develops and implements standard programming practices while also ensuring that they are employed across studies and programs
• Mentors less experienced programmers

Requirements:

• 5-10 years SAS Base programming, with 5-7 years using SAS STAT, GRAPH and MACRO
• 5-10 years relevant industry experience
• 5-10 years clinical trial experience
• At least 2 years clinical database experience
• Excellent knowledge of drug development process
• Knowledge of drug submission requirements

Education:

• Must have a Bachelor's degree or equivalent, preferably in a scientific discipline (i.e. Statistics, Mathematics, Economics, Computer Science, IT, Biology, Life Science)

To apply, please send your MS Word resume along with salary requirements to:
SPalakurthi@radiants.com

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.

Job Description:

Job Title: Clinical Business Planning Manager
Location: Cambridge, MA
Company: Radiant Info Systems
Contract: Duration: 4 months

Radiant Info Systems is looking for a Clinical Business Planning Manager for its Cambridge, MA office.

Responsibilities:

• Responsible for financially managing overall programs and highly complex, large volume trial budgets, determining the methodology for forecasting each account
• Supervises or performs monthly financial planning, accrual calculations, accrual reconciliations, and justification of liability held on accounting books
• Responsible for the leadership of the monthly budget review meetings
• Analyzes, finalizes, and is accountable for all variance commentary
• Creates, as needed, ad hoc financial and operational reports
• Builds financial scenarios to support program decisions
• Develops annual Long Range Planning projections reflecting approved Clinical Development Plans
• Involved with, or manages, initiatives that are rooted in the details of clinical trial financial management
• Responsible for maintaining compliance for financial transactions within the clinical trial area by careful management of Purchase Orders (PO), PO requests, work approvals, and vendor contract amendments related to clinical trials
• Will participate in or may lead complex, multifunction initiatives
• Will contribute to the development of SOPs and Work Instructions that support clinical trial financial resource management
• May take on roll of supervisor or manager
• Operates and responsible for driving activities/influencing beyond individual department
• Establishes and implements standard practices, processes and procedures for group/department/program
• Will supervise professional subordinates to handle direct workload
• Helps to develop departmental budget and prioritizes resources and timelines to complete multiple projects within budget
• Ready to mentor and train new CBP personnel
• Interacts with Clinical Program Leads, Contract Managers, Contracts Associates, Clinical Trial Managers, Clinical Trial Coordinators of studies to which CBP is assigned by supporting the operational strategy/planning with relevant industry and BIIB-specific benchmarks
• Interacts with accountant to assist with monthly accrual process and subsequent reconciliation
• Interacts with R&D Finance counterpart to communicate significant budget/scope changes on studies/programs assigned
• Will directly interact with external vendors on business terms

To apply, please send your MS Word resume along with salary requirements to:
SPalakurthi@radiants.com

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.

Job Description:

Job Title: Statistical Submissions Management Senior Analyst III
Location: Cambridge, MA
Company: Radiant Info Systems
Contract: Duration: 12 months

Radiant Info Systems is looking for a Statistical Submissions Management Senior Analyst III for its Cambridge, MA office.

Responsibilities:

• Coordinating, preparing, reviewing and managing Biostatistics electronic submission ready components for complex regulatory submissions
• Monitoring and meeting assigned project milestones and requesting resources while providing adequate submission status tracking reports, as well as metrics reports, to communicate progress and trends of electronic submission activities (i.e. submissions plans)
• Developing or implementing standard electronic submission practices and standards, while also ensuring that they are employed across studies and drug programs
• Providing submission support to complex ad-hoc and response requests from regulatory agencies

Requirements:

• Able to handle a large volume of highly complex tasks and work effectively under pressure and tight deadlines
• Able to use SAS programming software intensively and to review SAS programs and prepare the submission components
• Must have experience with clinical trial data and software used for electronic submissions purposes
• Must have great general computer proficiency, including Microsoft Suite applications
• Must have 5-10 years Adobe Acrobat and electronic submission applications experience utilized for electronic submission purposes
• Must have 5-10 years SAS experience with some demonstrated programming language experience
• Must have 5-10 years relevant experience in the pharmaceutical, biotechnology industry or CRO
• Must have a demonstrated ability in supporting project teams and management
• Must have extensive knowledge and application of applicable industry principles, concepts, techniques, and standards
• Must have full knowledge of applicable regulations and industry practices and ability to utilize the knowledge in the practice
• Must have excellent application of concepts and principles of electronic submission and drug development process

Education:

• Must have a Bachelor's degree or equivalent, preferably in a scientific discipline (i.e. Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.)

To apply, please send your MS Word resume along with salary requirements to:
SPalakurthi@radiants.com

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.

Job Title: Assay Scientist
Location: State College, PA
Recruiting Firm: The HR Office, Inc.

Job description:
Our client, a growing biotechnology firm located in Central Pennsylvania, is looking to add a talented individual to their team.

Under direction of the Principal Scientist, develop and conduct research studies to enhance performance of existing assays and to develop new assays pertinent to the immunoassay industry. The Assay Scientist will, independently or with the Principal Scientist, develop test designs, perform testing, and analyze complex datasets for summary and documentation.

Responsibilities:
• Conduct research and development activities according to company goals
• Design experiments, analyze data, interpret and summarize results
• Perform assay validation under company guidelines, including writing protocols, developing testing plans, execute tests, analyze data and prepare summaries for regulatory applications
• Prepare required test solutions and complete calculations of results
• Statistical analysis
• Interpret results of tests and make recommendations
• Operate, maintain and order necessary equipment and supplies
• Maintain detailed test documentation and data
• Submit device control change documentation
• Participate in CAPA and DCC investigations

Education / Experience Required::
• MS in Chemistry, Biology, Biochemistry or related field with 5 years of experience in biological, medical, or veterinary sciences or similar scientific field specializing in assay development or characterization of assay performance
• Experience in an industrial environment preferred
• Equivalent combination of education and experience

Additional Requirements:
• Proficient in the practice and daily activities of laboratory science
• Thorough knowledge of scientific principles and disciplines
• Direct experience and comprehensive understanding of immunoassay technology
• Technical leadership abilities as an individual contributor

If interested, please submit your MS Word resume with salary requirements to lhaft@thehrofficeinc.com

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.

Job Description:

Job Title: QC Associate I
Location: South San Francisco, CA
Recruiting Firm: Q Analysts

Q Analysts is looking for an QC Associate I for one of its client's located in South San Francisco, CA.

Responsibilities:

• Sharing responsibilities for routine lab operation and maintance.
• Perform general wet chemistry assays such as pH determination, total organic carbon (TOC), and protein concentration by UV spec scan and endotoxin detection by LAL testing.
• Routine support of the Quality Control sample management process.
• Daily duties and responsibilities would include sample receipt from manufacturing, log in, verification, sample handling and internal transfer within QC.

Skills:

• Ability to work well with others in a positive and collaborative manner. Computer literacy and experience working in a cGMP environment are preferred, but not required.
• Understanding of analytical techniques cited above is required.
Education:

• BS/BA in Biochemistry, Chemistry or related field

To apply, please send your MS Word resume along with salary requirements to:
mmathews@qanalysts.com

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.

Job Description:

Job Title: Sr. Tech Manager
Location: South San Francisco, CA
Recruiting Firm: Q Analysts

Q Analysts is looking for an Sr. Tech Manager for one of its client's located in South San Francisco, CA.

The purpose of this position is to provide quality oversight and expertise for the selection, implementation and management of manufacture of small molecule API and Drug Product at contract manufacturing organizations.

Responsibilities:

• Build strong relationships with both internal operations units and external CMOs and partners.
• Participate in due diligence visits to assess CMO's Quality Systems for processing of investigational / commercial medicinal products.
• Negotiate and maintain Quality Agreements with selected CMOs and ensure the requirements of the Quality Agreement are fulfilled. Ensure product-specific requirements are met.
• Ensure that manufacture and testing of clinical supplies of the client's small molecule & ADC products at contract manufacturing organizations (CMOs) is conducted in accordance with cGMP.
• Follow up on any corrective actions identified as a result of the client's audits.
• Write and execute CMO facility/process GMP commissioning plans to ensure all quality requirements are met prior to manufacturing.
• Review and approve master batch records for compliance to clinical trial protocols, regulatory filings, pertinent product requirements and cGMP compliance.
• Perform person-in-the-plant activities as required during GMP manufacturing.
• Review batch records and assess deviations and investigations.
• Review CMC sections of regulatory filings.
• Participate in the design, implementation and maintenance of quality systems for small molecules for execution of the above functions.

Skills:

• Demonstrated working knowledge of Quality Assurance and manufacturing principles.
• Sound knowledge of US cGMPs and an ability to apply sound judgment and decision-making skills in order to evaluate product release is necessary.
• Working knowledge of worldwide cGMP regulations desired.
• Excellent written and verbal communication skills.
• Strong interpersonal skills and negotiation skills.

Education:

• At least 5 to 10 years relevant pharmaceutical experience with small molecules, experience in solid dosage form manufacturing is desired.
• At least 4 years direct experience in quality assurance for pharmaceutical operations.
• BS/BA in a relevant scientific discipline or equivalent

To apply, please send your MS Word resume along with salary requirements to:
mmathews@qanalysts.com

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.

Job Description:

Job Title: Associate Director
Location: South San Francisco, CA
Recruiting Firm: Q Analysts

Q Analysts is looking for an Associate Director for one of its client's located in South San Francisco, CA.

Responsibilities:

• Accountable for the development and deployment of the External Quality strategy for the selection and operation of Contract Manufacturing Organizations (CMO) that support the global Small Molecule product development effort at Roche (PTD, pRed and gRed).
• Accountable for all aspects of Quality related to these CMO's to include: Quality Systems, Product Quality Operations, Assay Qualification and Validation, cGMP Compliance, Risk Management, and Inspection Readiness.
• Responsible for ensuring that all GMP activities are in the best interest of the patients, comply with global regulations and uphold Roche's reputation as a reliable, high quality supplier of IMP products.
• In collaboration with other PTx, gRed and pRed functions, ensures appropriate measures are employed to fulfill the requirements of phase appropriate cGMPs, international standards and requirements.
• Responsible for management of risk, through proactive risk management tools and approaches for each CMO within the Roche Small Molecule Development Network.
• Accountable for the management of Quality and Compliance within the External Quality Small Molecule Development group to include: staffing, talent management, performance management, financial performance, and execution to meet strategic and operational objectives.

Skills:

• Minimum 12 years of direct work experience in the pharmaceutical industry.
• Demonstrated leadership experience in a Pharmaceutical Development environment.
• Strong knowledge of cGMP and Quality requirements for various early and late phase clinical stages.
• Experience technical aspects of pharmaceutical manufacture (Starting materials, API, Solid Dosage Form, and Packaging).
• Experience in reviewing and approving IND, IMPD and NDA documentation for submission to health authorities.
• Demonstrated leadership and execution of Quality Operations and processes. Established track record of Quality and Compliance decision-making.
• International experience working with ex-US manufacturing, EU QP's, and ROW cGMP Sophisticated negotiation and influencing skills.
• Strong leadership and communication skills.

Education:

• Minimum BS degree. MS, PhD in chemistry or chemical engineering.

To apply, please send your MS Word resume along with salary requirements to:
mmathews@qanalysts.com

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.