August 2010 Archives

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.