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