Purification Development Scientist

Ropella and Associates, the leading Executive Search Firm specializing in the Chemical and Allied Industries, has been retained to fill the position of a Purification Development Scientist for a cutting edge Biotechnology Firm.

The Company:
This exciting, dynamic, rapidly growing biotechnology organization has separated itself from the competition with its forethought and innovative technology portfolio. Current research focuses on highly advanced technologies for purification and development of proteins, peptides and antibodies using displacement chromatography to produce valuable products for these markets.

Responsibilities:
• Establishing and operating lab-scale displacement chromatography applications
• Independent design, execution and interpretation of experiments related to the purification and development process
• Developing application packages for customer presentations and for outside publications
• Supervising and carrying out laboratory studies in order to provide supporting data for the development of intellectual property

Requirements:
• A solid understanding of chromatography, separations and related areas
• Familiarity in downstream processing and chromatographic purification techniques for proteins, peptides, antibodies, enzymes or oligonucleotides
• Good planning, organizational and communication skills
• Proven success in leading complex projects and delivering them to a successful conclusion
• Ph.D. in Biochemistry, Molecular Biology, Chemistry, Life Sciences, Chemical or Biochemical Engineering and 6-15 years experience preferred

If you have open positions in your organization, give us a call and put our people and our process to work for you.

Know someone who is perfect for this position? Please forward this opportunity announcement to them ASAP. Also, please let us know of anyone else who should be in our network.

PUT ROPELLA & ASSOCIATES TO WORK FOR YOU
www.ropella.com

To apply, please send your resume with salary requirements and position of interest to:
Contact:
Name: Robin Klempa
Email: klempa@ropella.com

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

Please reference BioTechPharmJobs.com when responding.

Sr. Project Manager Assistant
Tarrytown, NJ

We have an existing client (Biopharmaceutical industry) that is looking for us to assist them in supplying a Senior Project Manager to work onsite at their Tarrytown, NY location for a 6-month contract period of performance.

Following is a summary of the position:

General Scope of Work
• Must have a general understanding of Project Management principles and can apply this knowledge to identify and resolve issues as they arise.
• Problem Solving: They have the ability to provide guidance and advice on the needs of the project and set goals appropriately.
• Knowledge: They have mastered several techniques and begin to demonstrate the ability to more quickly acquire and master new skills.
• Typical activities involve meeting management, functional coordination, developing productivity or tracking tools, following up on action items.

Job Description
• Manages cross functional teams in a matrix organization in order to plan and execute the development strategy for a clinical development program. Cross functional areas include: clinical, regulatory, pre-clinical, manufacturing, research, patents, marketing, alliance management and finance, among others.
• Coordinates the development, management and execution of drug development plans, timelines and budgets for assigned programs.
• Together with the Team Leader, reviews the status of projects and budgets; Manages, schedules and prepares status reports and development plans for Sr. Management.
• Liaises with respective functions responsible for the project and provides guidance on resolving project challenges by developing solutions to meet productivity and quality goals and objectives.
• Develops tools and mechanisms for monitoring project progress for intervention and problem solving with project and line managers.
• Coordinates the interactions b/w REGN and corporate partners for the development program if applicable • Ensures that all activities commissioned to the team comply with company standards, and US / EU Regulations (where applicable).

Minimum Education Required: BS with a minimum of six years experience in Project Management, or an advanced degree with relevant Project Management work experience

For consideration, please send a current resume with salary requirements and title of position of interest to, jgoodman@projectassistants.com.

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


Please reference BioTechPharmJobs.com when responding.

Supports the organization's mission, vision, and values by exhibiting the following behaviors: excellence and competence, collaboration, innovation, respect personalization, commitment to our community, and accountability and ownership.

POSITION SUMMARY:
The Quality Control Analyst I is a vital position in the Quality systems approach. The QC Analyst I will be responsible for chemical evaluation and testing of final product, intermediate products, stability samples and raw materials. Will assure ship schedules and contract testing requirements are met.

PRINCIPLE DUTIES AND RESPONSIBILITIES:
• Perform all chemical evaluation and testing of final product, intermediate products, stability samples and raw materials.
• Performing QC assays.
• Maintenance and calibration of all laboratory equipment.
• Preparation of solutions and solvents as needed.
• Responsible for monitoring and maintaining reagents needed for testing requirements.
• Will be required to perform other duties as requested, directed or assigned.

QUALIFICATIONS/SKILLS & KNOWLEDGE REQUIREMENTS
• 0-3 years Pharmaceutical experience or related field.
• BS degree in chemistry or a related field.
• Has knowledge of commonly used practices and procedures within a particular field.
• Computer skills proficient in use of e-mail, Access, Word, and Excel.
• Experienced in the use of High Performance Liquid Chromatographs (HPLC), UV, Dissolution apparatus, IR, GC, wet chemistry, as well as microbiological testing are desirable.
• Willing to learn and adapt to a changing environment, which may include new job assignments or special projects.
• Oral and written communication skills, strong interpersonal skills, and superior organizational abilities.
• Ability to take initiative, to maintain confidentiality, to meet deadlines, and to work in a team environment is essential.
• Relies on instructions and pre-established guidelines to perform the functions of the job.

GENERAL INFORMATION:
The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and skills required of personnel so classified.

The incumbent must be able to work in a fast-paced environment with demonstrated ability to juggle and prioritize multiple, competing tasks and demands and to seek supervisory assistance as appropriate.

Incumbents within this position may be required to assist or find appropriate assistance to make accommodations for disabled individuals in order to ensure access to the organization's services (may include: visitors, patients, employees, or others).

Physical Demands:
Regularly required to sit or stand, reach, bend and move about the production facility and lifting of moderately heavy items such as test equipment kits and product cases. Working around moving machines in production facility, and the handling and testing of food grade chemicals. Other physical demands include climbing, crouching, and reaching. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Personal Protective Equipment:
• Respirator (Dust) Masks, Lab coats, gloves, sleeve protectors, steel toe shoes, etc.

Work Environment:
Work performed in an laboratory/office environment which involves moderate risks or discomforts that will require special safety precautions, e.g., working around moving machines in production facilities, handling and testing of food grade chemicals as well as hazardous materials (reagents used in the laboratory). The work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

If you are interested in joining a team of professionals who are making a difference in the health of others, please contact Red River Pharma. Red River Pharma LLC offers a competitive compensation package and the satisfaction of belonging to a dynamic and vibrant health sciences organization.

For consideration, please mail/fax your resume indicating position of interest, to:

Red River Pharma LLC
Attn: Human Resources
PO Box 3723
Shreveport, LA 71133

Fax 318-678-8367

email: pnetherton@redriverpharma.com

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

Please reference BioTechPharmJobs.com when responding.

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.

Quality Assurance Manager

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

Description:
Perform a variety of activities to ensure compliance with applicable regulatory requirements and facilitate the management of third-party contract manufacturing organizations. Participate in the design, establishment and maintenance of programs and processes that ensure quality products and compliance with current Good Manufacturing Practices (cGMPs) for pharmaceutical, biotech and drug/device combination products. Author, edit, review, and approve policies, SOPs, and guidance documents. Manage and administer processes within the company's Quality System. Collaborate with functional groups and contract manufacturers to evaluate and address complex issues such as deviations, technical complaints, corrective and preventive action (CAPA) and failure investigations. May lead or coordinate investigations and corrective and preventive action (CAPA) recommendations related to products. Lead or assist compliance audits (GMP, GLP, GCP, Internal and Supplier/External). Work with R&D as QA representative during new product start-ups, and identify routine checkpoints for new products and processes. Contribute to the completion of CMC sections of regulatory submissions. Provide Quality oversight for the labeling, packaging, storage, and distribution of clinical trial materials.

Requirements:

Bachelor's or Master's Degree in a relevant scientific discipline with 5+ years demonstrated QA experience in a pharmaceutical or biotech company. Prior compliance work with sterile product, aseptic manufacturing processes, or drug/device combination products is highly desirable. Must have an understanding and application of FDA regulations and guidances, QA principles, concepts, industry practices, and standards.

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. QAM_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.

Manager of BDMP, Quality and Training

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

Position Description:
Develops and trains to BDMP SOPs, WIMs, training material and other controlled documents. Applies regulatory ICH, GCP, and ISO quality system requirements to ensure appropriate SOPs, WIMs, and processes are in place and are adequately controlled and implemented within BDMP. Responsibilities are as follows: Participates in the development, training, and maintenance of BDMP controlled documents to ensure global adherence to Good Clinical Practices (GCPs) and related regulations and guidelines. Acts as liaison on teams with other departments, such as Clinical Quality and Training, Clinical Research, RDSIS, WWQA, and Global Regulatory Compliance. Supports ISO-13485:2003 Certification Activities, including complying with WWQA standards, training BDMP, coordinating all preparatory activities within BDMP, participating in the audit and response.

Requirements:

A BS/BA degree, or equivalent experience, in a science, math, or computer science discipline, with an additional 8 years experience in a relevant field; or an MS degree, or equivalent experience, with an additional 6 years experience. A minimum of 4 years of experience directly related to a BDMP-technical area, or 2 years of experience directly related to a BDMP-technical area and 2 years of BDMP or Clinical GCP training experience.

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. MBQT_1108, 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.

Senior Manager / Associate Director / Director of GCP Compliance

Urgent requirement for one of our top clients located in Seattle, WA.

Description:
This position will be responsible for managing and maintaining the global GCP compliance program to ensure that clinical development is conducted in conformance with global regulatory requirements. This includes reviewing and auditing clinical operational systems (internal and external) impacted by European EMEA, ICH and US FDA regulations and extensive interaction and cooperation with clinical operations and regulatory functions to create a team approach to the evaluation. This position is also accountable for routine periodic reporting to management regarding audit findings and corrective action progress and the development and management of vendor qualification program including but not limited to pre-approval inspection readiness. This position will also manage GCP auditing staff.

Requirement: Requires BS in Life Sciences or health related field or equivalent and 8+ years of applicable experience required with at least 5 years experience in global GCP compliance auditing in the pharmaceutical industry. At least 2+ years management of audit staff; global management experience is highly desired. Experience in clinical operational or clinical trial management environment is a plus. GCP compliance training experience is required.

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 and job No. SMGC_122907, 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.

Clinical QA Auditor

Urgent requirement for one of our top clients located in Brisbane, CA.

Description:
Plans and conducts GCP audits of Company's sponsored clinical trials, CROs, vendors, clinical laboratories, internal processes, databases and clinical study reports, as necessary. Provides assurance that clinical trials are conducted and that data generated and reported are in compliance with protocols, GCP, regulatory requirements through document reviews and audits. Conducts audits to evaluate internal processes related to conduct and reporting of clinical trials to assure compliance with study protocols, SOPs, GCPs, and regulatory requirements. Issues audit reports, recommends corrective action and may conduct follow up to audits and corrective actions. Provides timely written reports to inform management of Company's regulatory status based on audits of CROs, investigator sites and internal audits of Company's processes. May participate in the management of clinical trial product complaint system. Assists in performing GCP training for internal and external customers as needed. Assists in development of Clinical QA Standard Operating procedures, as required.

Requirements:
A BA/BS degree in the sciences, R.N. or equivalent experience. Minimum of 2 years experience in the Biopharmaceutical industry including at least 1 year experience auditing clinical sites and CROs, clinical laboratories, clinical study reports, or internal systems or at least one year experience as CRA. Demonstrates a thorough knowledge of GCP federal regulations and ICH guidelines and other regulations as applicable.

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. BD_122707, 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.

Part Time Territory Rep - Pharmaceutical Sales

In the following locations:
• Palm Springs, CA
• Colorado Springs, CO
• Baltimore, MD
• Silver Spring, MD
• Boise, ID
• Sioux Falls, SD
• Skokie, IL
• Burlington, MA

Wyeth is a global leader in pharmaceuticals, consumer health care, and animal health care products. We are committed to providing work-life balance and are seeking dedicated individuals who are motivated by flexibility and driven by sales.
Qualified candidates must have a minimum 2 years pharmaceutical sales experience and be willing to work a 19 hr work week. To assist our representatives Wyeth will provide Mileage and cell phone compensation, as well as a laptop PC for daily communications and organization.

As a Flexible Territory Representative, you will have the opportunity to call regularly on health care professionals and support the promotional effort behind the products. You will maintain a current and competent level of knowledge on the product line, to be a reliable source of information to the health care professionals in the territory and bring value to the offices.

The key responsibilities for this position are:
• Create and execute an effective call plan
• Utilize reporting tools provided to achieve territorial goals
• Communicate and collaborate with the District Manager on goals
• Build business relationships with assigned customers
• Communicate key product messages(e.g. anatomy, physiology, disease state, and treatment options)
• Utilize your customer focused selling skills in your presentations, keeping post call notes to assist with pre-call planning
• Attend and participate in quarterly POA meetings
• Merchandizing our samples and support materials for maximum impact
• Responsible for being in compliance with Drivers Safety Guidelines, and your personal automobile insurance coverage requirement
• You will have the opportunity to prospect for new business and evaluate the sales potential of existing customers
• You will distribute samples to only licensed practitioners, and will follow all samples regulations.

This position requires a 4 year Bachelor's degree BA/BS with a minimum of 2 years of Pharma sales experience. Must have a demonstrated ability to promote and sell goods, services, and concepts. Demonstrated effective organizational and communication skills are required, as well as the ability to work as directed. You will have the occasion to undertake a program of self-development.

Apply today by submitting information online at www.wyeth.com

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

listing jobs Wyeth Palm Springs California USA

Please reference BioTechPharmJobs.com when responding.

CALLING ALL ROAD WARRIORS

Ropella & Associates, the largest executive search firm exclusively serving the chemical and allied industries, is seeking 2 Pharmaceutical Business Development Principals for one of the largest commercial testing labs in the country. Passionate sales people with an ability to self-motivate and a love of travel only need apply!

Our Client:
• Posts annual sales of more than $75 Million dollars
• Has a diverse client base including 19 of the 20 largest pharmaceutical companies in the world
• Received the 2007 Ethics in Business Award form the Samaritan Counseling Center
• Has one of the lowest employee turnover rates in the analytical lab business

Locations:
• The successful candidates will work out of their own home based office which the company will fully equip
• Residence anywhere on the West Coast or in the New England States


Key Responsibilities:
• Develop new revenue from pharmaceutical and Biopharmaceutical firms
• Account management of prospects in R&D and commercial markets
• Assist in quote and proposal generation for the pharmaceutical division
• Develop Sales Tools and Plans
• Extensive travel throughout the assigned territory


The Ideal Candidate Must Possess:
• BS/BA in a science related field
• Proven track record in selling contract analytical services
• Thorough understanding of the pharmaceutical and Biopharmaceutical industry


For more information and to be considered for this position please send a current resume to Robin Klempa, klempa@ropella.com. Your privacy is very important to us; we will not submit your resume to an employer without your consent. To learn more about Ropella and Associates, and to see other opportunities we are working on, please visit our website at www.ropella.com.

Know someone who is perfect for this position? Please forward this opportunity announcement to them ASAP.

PUT ROPELLA & ASSOCIATES TO WORK FOR YOU
www.ropella.com

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


listing jobs Ropella Associates Boston Massachusetts USA

Please reference BioTechPharmJobs.com when responding.