Position: Scientist, Testing & Analytical Services
Location: King of Prussia (onsite)
Company: Sk Pharmteco
The Company:
The Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from concept to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle. CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.
About the Role:
The primary focus of the Scientist, Testing & Analytical Services – Cell-based Potency, is to support the execution of preclinical potency assays for cell and gene therapy products for internal and client programs. This involves collaborating closely with various teams, including process development, R&D, Quality Assurance, and program leadership, to ensure compliance with project timelines and industry regulations. Additionally, the role encompasses independently applying scientific knowledge, advancing departmental goals, and optimizing workflows for successful project outcomes. The Scientist will be independent and detail-oriented, have experience in design and development of cell-based assays and a strong background in Cell Biology, Molecular Biology, and Immunology.
Primary Responsibilities:
• Demonstrate the highest moral standard and ethical integrity.
• Optimize and qualify assays for characterization and routine testing of cell and gene therapy products.
• Author and review test methods, qualification protocols and reports, and risk assessments.
• Lead the technical transfer of analytical methods to Testing & Analytical Services.
• Represent the Cell-based Potency team in cross-functional meetings.
• Perform GMP operations, including following detailed SOPs, maintaining training, and following good documentation practices.
• Perform other related duties as assigned.
Education, Experience, & Qualification:
• Master’s degree (or an equivalent combination of education and experience) or Bachelor’s degree with 2+ years of relevant experience in biotech, pharmaceutical industries, or related field, preferably in the Cell and Gene Therapy field.
• Strong background in cell culture and experience working with immortalized cell lines and primary cells.
• Experience with mechanism of action, functional, or potency assay development.
• Hands-on experience with FACS (such as the MACSQuant Analyzer 16 and BD FACSLyric) and data analysis is highly desirable.
• Broad experience with molecular biology, cellular, and immunoassay techniques including transfections/transductions, ddPCR/qPCR, ELISA.
• Experience working with AAV, Lentivirus, and Adenovirus vectors is a plus.
• Experience using data analysis software, such as SoftMax, JMP and, PLA.
• Prior exposure to cGMP is highly preferred.
• Knowledge of FDA/ICH guidelines and experience with assay qualification/validation preferred.
Key Competencies:
• Excellent verbal and written communication skills.
• Excellent organizational skills and attention to detail.
• Excellent time management skills with a proven ability to meet project objectives.
• Strong analytical and problem-solving skills.
• Ability to prioritize tasks and to delegate them when appropriate.
• Ability to function well in a fast-paced environment.
• Ability to function both independently and as part of a team.
• Proficient with Microsoft Office Suite or related software.
Physical Requirements:
• Prolonged periods of sitting at a desk and working on a computer.
• Prolonged periods of standing during laboratory work.
• Must be able to lift up to 15 pounds at times.
As an Equal Opportunity Employer, we believe in each person’s potential. Qualified applicants will receive consideration for employment without regard to
race, color, religion, sex, age, national origin, sexual orientation, gender identity, disability or any other protected category including veteran status.
