Research Scientist

Proclinical is currently recruiting for a Research Scientist with a pharmaceutical company located in Philadelphia, PA.

Job Responsibilities:

• Provide guidance to internal and external customers on appropriate testing strategies and sampling plans for cell and gene therapy clients.
• Stay current in the field of cell and gene therapy regulations with respect to both testing and manufacturing guidelines.
• Serve as a core team member on multiple manufacturing teams and serve as the Analytical lead. Collaborate with Process Development and client to ensure sampling plans are accurate. Coordinate with Analytical Development sub-teams, Testing Operations, and Client Delivery to ensure analytical timelines stay on track. Continually communicate accurate timelines to core team leads and project management.

• Design, conduct and coordinate assay development projects from inception to completion for the development of new assays needed to support manufacturing and testing programs.
• Conduct critical review of results and report data to management and project teams. Effectively present detailed data to clients on teleconferences and face to face routinely.
• Write research and development reports and ensure all data is represented clearly and accurately.
• Author assay qualification and validation protocols and reports.
• Prepare and revise technical documents (Laboratory Protocols, SOPs, etc.)
• Demonstrate exceptional written and oral communication
• Effectively interact with clients to address testing and related questions.
• Author risk assessments, as needed.
• Completes all required training (i.e. safety, equipment etc.).
• Attends scientific conferences, when feasible.
• Ability to work in a team environment and independently as required.
• Maybe required to work Holidays and weekends.
• Contributes to the overall operations and to the achievement of departmental goals.
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and our Policies and Standard Operating Procedures.
• Thorough understanding of Good Manufacturing Practices

Skills and Requirements:

• A PhD in Life Sciences or related field with 5 to 10 years of experience in a biopharmaceutical or biological contract testing/manufacturing organization.
• A BS/MS in Life Sciences 12+ years of experience in a biopharmaceutical or biological contract testing/manufacturing organization.
• Thorough knowledge of FDA regulatory guidance documents and EU regulations with respect to testing requirements for Cell and Gene Therapy products.
• Experience developing and defending testing strategies for biological products.
• Ability to design and develop new assays and direct junior scientists in day to day laboratory work, as needed.
• Strong oral and written communication skills. Ability to write reports, meeting agendas/minutes, business correspondence, and procedures such as SOPs
• Strong organizational skills with the ability to multi-task and prioritize assignments
• Excellent critical thinking and problem solving abilities
• Ability to effectively manage multiple projects under short time lines
• Ability to work under pressure and effectively lead in a fast-paced, dynamic technical environment
• Ability to be flexible and work in cross-functional teams
• A working knowledge of GMP guidelines is required
• Experience with Microsoft Project is a plus
• Must be able to work in an environment with variable noise conditions.
• Must be able to work in Lab setting with exposure to Biohazards / Chemicals
• Ability to identify and distinguish colors, preferred

If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at 267-428-7770.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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