Position Title: Associate Scientist, Upstream Process Development

Company: Sk Pharmteco

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. The Associate Scientist will execute in-process analytical testing for cell and gene therapy products with a multidisciplinary Process Development team.

About the Role:

The Associate Scientist, (Upstream Viral Vector Process Development) is responsible for supporting process development for viral vector production for internal and client programs under the supervision of a senior scientist or manager. The primary responsibilities are the design of and execution of upstream experiments, the analysis of study results, and writing of reports to communicate those results to key stakeholders. Candidates may have limited experience in cell culture, scale up, design of experiments, GxP documentation, process analytics, data analysis, low level statistical analysis, and technical report authoring and review. Experience in project management, viral vector production and suspension or adherent mammalian cell culture is a plus, but not required.

Primary Responsibilities:

• Become the Subject Matter Expert (SME) and support upstream development under supervision of the Senior Scientist or Manager.
• Execute process development activities from design of experiment to execution of established protocols.
• Perform experiments in the development, optimization, and scale-up of production processes.
• Prepare and review process development protocols, data analysis summaries, technical reports, and other relevant process documentation.
• Develop and update process SOPs and batch records.
• Manage lab supply ordering and inventory as required.
• Follow GXP practices and maintain a safe working environment.
• Interact with clients as needed.
• Support technology transfer of viral vector processes into manufacturing.
• Maintain detailed electronic and paper records. Perform other duties as assigned.
• Support experimental preparations
• Proficient with Microsoft Office Suite or related software. Statistical software experience is a plus.

Key Competencies:

• Understanding of basic cell culture biology and related techniques.
• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills.
• Excellent organizational skills and attention to detail.
• Excellent time management skills with a proven ability to meet deadlines.
• Strong analytical and problem-solving skills.
• Ability to prioritize tasks and to delegate them when appropriate.
• Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities
• Takes ownership of the assigned project, consulting with management and peers.
• Able to understand and interpret data/information and its practical applications.

Education:

• B.S. in engineering, life sciences, or related field, plus 1-3 years in relevant academic or industry technical experience or M.S. in engineering, life sciences, or related field, plus 0-2 years in relevant academic or industry technical experience

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.