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Entries tagged with “process” from BiotechPharmJobs.com

Boehringer-Ingelheim: Automation & Controls Engineer III, Columbus, OH

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Boehringer-Ingelheim


Job Title: Automation & Controls Engineer III
Company: Boehringer-Ingelheim
Location: Columbus, OH
Job Type: Full-Time

Directly responsible for the management and execution of all Engineering activities related to automation solutions for production and/or facility equipment.

Provide operational support, complex troubleshooting, and optimization for automation equipment, directing and coordinating activities to improve reliability, and applying advanced engineering principles to the design and implementation of new equipment.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Responsibilities:
• Partner with Engineering lead to support the design, specification, installation, startup and validation of process control systems, electrical systems and instrumentation for capital and upgrade projects
• Ensure site specifications, standards and cGMP compliance to expectations are met and that good engineering practices are followed
• Coordinate with other engineers, project managers, and suppliers to assure a complete and timely design and implementation
• Direct more complex group projects - identify, propose and champion creative and constructive solutions articulating the business value created
• Monitor and communicate progress on all projects within the assigned portfolio to successfully deliver project scope, timeline and budget objectives
• Maintain a "state of control" over systems by assuring maintenance of as-built drawings, system documentation and EX rating management
• Coordinate with Operations to identify requirements for process controls, develop control strategies and implement
• Research new technologies and procedures relative to automation and controls that could be utilized to improve the business and processes
• Analyze, compare and select equipment best suited for various applications
• Contribute to functional forums at the site, regionally, and within the Global Engineering Network
• Support standards development and master planning activities
• Troubleshoot control and instrumentation systems to resolve complex equipment issues
• Provide engineering expertise and technical guidance to maintenance to perform repairs, design changes, or other corrections as a result of troubleshooting or performance evaluation
• Identify continuous improvement activities relative to automation control systems throughout the site and champion solutions aligned with Site and Department metrics, Business Objectives and Strategy
• Identify areas of opportunity to improve equipment and component reliability
• Mentor peers and site resources on automation and control systems of production equipment
• Provide training and technical supervision to instrumentation and electrical personnel as well as Flow technicians for automation control systems throughout the site
• Develop calibration, preventative maintenance and additional procedures in support of systems and instruments installed

Qualifications:
• 6+ years of experience in all areas of process control systems encompassing instrumentation, automated control, and electrical distribution, preferably in the chemical, food, or pharmaceutical industries
• Experience with network and system administration of Microsoft based systems, Visual Basic, and SQL is preferred
• Experience in programming/troubleshooting Programmable Logic Controllers (PLCs)
• Experience with Allen-Bradley, Modicon, and Siemens S7 PLCs is preferred
• Experience in programming and configuration of Supervisory Control and Data Acquisition (SCADA) systems; experience with Wonderware products is preferred
• Demonstrated computer skills, including but not limited to, MS Excel, Word, PowerPoint, Project and AutoCAD
• Proven ability to simultaneously manage multiple projects and initiatives
• Demonstrated successful communication and negotiation skills in order to manage conflicting and/or multiple demands, including ability to present to various level within an organization
• Demonstrated ability to apply analytical skills to identify problems; recognizes symptoms, causes, and alternate solutions and makes timely sound decisions even under risk and uncertainty
• 4 to 6 years of leadership experience

Desired Experience, Skills and Abilities:
• Direct and intimate knowledge of applicable laws and regulations including those mandated by FDA, DEA, EMEA, OSHA, Building Code, NFPA, & EPA
• Strong Project Management skills coupled with the ability to effectively manage and partner with subordinates, contractors and vendors
• General understanding of the business case and an appreciation of financial / analytical issues

Eligibility Requirements:
• Must be legally authorized to work in the United States without restriction
• Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background
• Must be willing to take a drug test and post-offer physical (if required)
• Must be 18 years of age or older

Our Culture:
Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Roxane Inc., Roxane Laboratories Inc., Boehringer Ingelheim Chemicals, Boehringer Ingelheim Vetmedica Inc. and Ben Venue Laboratories Inc., is an equal opportunity employer. M/F/D/V

To apply, please click here.

Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings.

Please reference BioTechPharmJobs.com when responding.

Luminex Corporation: Regulatory Affairs Associate II, Madison, WI

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Luminex Corporation


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

The Luminex Corporation seeks a Regulatory Affairs Associate II for its Madison, WI office.

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
• Prepares and assists in 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
• Prepares and evaluates regulatory documents and company specific SOPs 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
• May assist with training and mentoring other RA associates and staff
• Other duties as required

Competencies:
• Learning on the Fly learns quickly/open to change
• Organizational Agilityâ€"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

Required Certifications/License/Special Skills:
• RA and/or CRA certification a plus
• Working knowledge of FDA submissions requirements and terminologies (Pre-Submission, 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:
• 3 years of industry experience in Regulatory Affairs, preparing and filing submissions such as 510(k), Pre-Submissions, IDE and maintaining regulatory documentation, registrations and device listings, both domestic and international
• Experience in a GMP and/or FDA regulated environment, medical device industry or equivalent
• Experience in medical device industry, in vitro medical devices preferred
• Experience as a Technician/Scientist or related biological discipline not required but considered an asset
• 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 approximately: 20% of the time
• 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:
• LLifting/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
• Stooping on the job is required
• 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.

Luminex Corporation: Reagent Manufacturing Associate, Madison, WI

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Luminex Corporation


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.

Merck: Analytical Program Lead, Union, NJ

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Merck


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.

Doe & Ingalls: Sales Specialty Chemicals for Life Sciences, San Francisco, CA

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Doe & Ingalls


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.

Doe & Ingalls: Sales Specialty Chemicals for Life Sciences, Riverside, CA

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Doe & Ingalls


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.

Doe & Ingalls: Sales Specialty Chemicals - MA/CT/NY, Springfield, MA

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Doe & Ingalls


Job Description:

Job Title: Sales Specialty Chemicals - MA/CT/NY
Location: Springfield, MA
Company: Doe & Ingalls
Job Industry: Biotechnology
Job Industry: Specialty Chemical Sales
Job Type: Full-Time
Travel Required: 25-50%

Doe & Ingalls is looking for a Sales Specialty Chemicals - MA/CT/NY Account Manager for its Springfield, MA location.

The Account Manager is responsible for managing existing customers and developing new business for the life sciences product lines and/or chemical management services throughout central/western Massachusetts, parts of Connecticut and New York.

Key duties and requirements:

• 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
• 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/zq5cykg

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.

Doe & Ingalls: Account Manager Life Sciences - MA/CT/NY, Danvers, MA

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Doe & Ingalls


Job Description:

Job Title: Account Manager, Life Sciences - MA/CT/NY
Location: Danvers, MA
Company: Doe & Ingalls
Job Industry: Biotechnology
Job Industry: Sales
Job Type: Full-Time
Travel Required: 50-75%


Doe & Ingalls is looking for a Account Manager, Life Sciences - MA/CT/NY for its Danvers, MA location.

The Account Manager is responsible for managing existing customers and developing new business for the life sciences product lines and/or chemical management services throughout central/western Massachusetts, parts of Connecticut and New York.

Key duties and requirements:

• 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 • 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/9826f9b

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.

Doe & Ingalls: Account Manager Life Sciences, Danvers, MA

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Doe & Ingalls


Job Description:

Job Title: Account Manager, Life Sciences
Location: Danvers, MA
Company: Doe & Ingalls
Job Industry: Biotechnology
Job Type: Full-Time
Travel Required: 50-75%


Doe & Ingalls is looking for a Account Manager, Life Sciences for its Danvers, MA location.

The Account Manager is responsible for managing existing customers and developing new business for the life sciences product lines and/or chemical management services throughout Eastern Massachusetts, parts of Connecticut and New Hampshire


Key duties and requirements:

• 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 • 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/97rvsyv

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.

Doe & Ingalls: Sales Account Manager - Life Sciences, Tampa, FL

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Doe & Ingalls


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.

The NMS Group: Strategic Planning Pharma Manager, Tarrytown, NY

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The NMS Group


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.

Q Analysts: QC Associate I, South San Francisco, CA

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Q Analysts


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.

Q Analysts: Sr Tech Manager, South San Francisco, CA

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Q Analysts


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.

eDynamic: Data Solutions Engineer, San Francisco, CA

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eDynamic


Job Description:

Job Title: Data Solutions Engineer
Location: San Francisco, CA
Length of Contract: 1 Year


eDynamic is looking for Data Solutions Engineer in San Francisco, CA. The Production Data Solutions Engineer is primarily responsible for designing, implementing and maintaining the Production information systems used to support FDA regulated biopharmaceutical manufacturing operations. The successful Consultant will:

• Lead the development of web-based data visualization tools using industry standard technologies such as ASP.NET, xMII, and Microsoft SharePoint.
• Provide tools to access manufacturing data from a variety of database and non-database sources to the entire Production Technology Group.
• Participate in the design, installation and testing of validated and non-validated computer information systems.
• Maintain manufacturing-related information systems, including data and batch historians, process dashboards, and provide technical support as needed.
• Ensure that work conforms to cGMP standards and all applicable codes and regulations from the CFR, Annex 11 and OSHA.

Requirements:

• 4+ years of Biotech/Pharma experience
• Knowledge of computer systems, relational databases, and experience utilizing Windows, the .NET Framework, PL/SQL, ASP.NET, C#, and/or relational databases to build software solutions.
• Experience with SAP, SAP xMII (formerly Light hammer), MES, InfoPlus.21, and IronSpeed software
• Working knowledge of SCADA software and programmable controllers for process control applications, redundant and high reliability computer and network hardware systems, programming language experience, or an understanding of biopharmaceutical process manufacturing.

To apply, please send your MS Word resume along with salary requirements to:
birendra.kumar@edynamic.net

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

Please reference BioTechPharmJobs.com when responding.

Makro Technologies: Process Development Scientist, Redwood City, CA

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Makro Technologies


Process Development Scientist - Protein Purification

Urgent requirement for one of our top clients located in Redwood City, CA.

Description:
The position will require hands-on work developing downstream processes, tech transfer of processes to CMOs and on- site interactions and management of CMOs to facilitate scale-up and clinical/commercial production. The incumbent will be responsible for developing, scaling up, & improving downstream processes in collaboration with external parties and the internally with the Protein Analysis group. The position requires the ability to develop and optimize downstream processes in accordance with regulatory requirements and the company's timelines for Phase III/commercialization. The individual will also be responsible for identification and implementation of improved technologies for R&D and commercial manufacture to enhance product quality, manufacturing cost efficiencies & regulatory compliance. The position is likely to require the management and training of junior staff.

Requirements:
Ph.D in Biochemistry or Biochemical Engineering with emphasis on Protein Purification and 5+ years of experience; or MS in Biochemistry or Biochemical Engineering with emphasis on Protein Purification and 10 plus years of relevant industrial experience. Experience in optimization and scale up of protein refolding from E. coli is a plus. Prior experience with various PEGylation methods at small and large scale is preferred.

Contact:
The most effective way of communication is via email please forward us your updated WORD FORMAT resume (Address, Contact number and email is must), including position of interest job No. PDS_1508, to *** anitha.maturi@makrotech.com ***

Please mention your best hourly rate, availability and visa status. Any questions, do feel free to email us.

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

Please reference BioTechPharmJobs.com when responding.
 

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