Entries tagged with “regulatory” from BiotechPharmJobs.com

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: 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.

We at MAKRO deliver custom client-centric solutions by offering contract outsourcing and premium staffing to the most well known IT and Life Science Organizations throughout United States.

Our vision is to become a most reliable "connector" between our clients and the Talent pool i.e "YOU."

Clinical Program Manager
Swiftwater, PA

Description:
• Defines project standards where necessary to ensure consistency across global projects
• Builds effective relationships internally and externally
• Manage information on project performance from all team members (including CROs), alerting the Clinical Team Leader and project team to any potential time slippage.
• Facilitates resolution of problems affecting the achievement of clinical project milestones
• Remain current on trends in individual therapeutic area by attendance at conferences and review of publications

Requirements:
• BSc with 3-5 years' experience in vaccinology / clinical research
• Formal training in GCP methods
• Proven track record in delivering high-quality GCP-compliant Clinical Trials
• International (ie. more than 1 regulatory environment) Clinical Trial experience preferred
• Knowledge of Code of Federal Regulations and regulatory agency documents

To apply, please forward your updated MS Word resume, including availability (if you are authorized to work in the United States for any employer), location and position preferences to glenn.davis@makroscientific.com ******** for review before we speak. or contact our Recruitment Helpdesk at 973-679-5005

Also if you have any friends or colleagues, working on similar skill set, kindly refer them as well as there are multiple open positions.

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

Please reference BioTechPharmJobs.com when responding.