Cell Line Development Scientist

Job Description:

General Summary:
 

The Cell Line Development (CLD) Scientist/Associate Scientist leads multiple client projects to meet timeline, budget, and scope commitments and has good working knowledge of CLD pertaining to drug development.  The Scientist has a good working knowledge of all relevant disciplines pertaining to CLD for drug development and knowledge of relevant business elements.  She/He keeps an up-to-date awareness of advances in multiple technological and scientific areas and has strong academic and industrial contacts. 

ESSENTIAL ROLES AND RESPONSIBILITIES

• Will be responsible for leading multiple client projects in parallel in CLD.
• Extensive experience in the transfection, selection, and development of stable CHO or HEK293 cell lines suitable for commercial production of therapeutic proteins
• Work closely with the mammalian Upstream Process Development (USP) team and R&D department on developing cell culture processes for client projects along with innovative internal experiments
• Perform process research and development on a variety of cell culture-derived biopharmaceuticals including mAbs, Fusion Proteins, Cytokines, and Bi-specifics
• Perform cell culture in Fed-Batch shake flask, AMBR15, AMBR250, and support process scale up in bioreactors
• Serve as a point-of-contact, primary owner, and subject matter expert for all CLD programs and initiatives and troubleshooting CLD problems
• Represent Cytovance and CLD technical area in client team meetings
• Align client and business goals to enable both client and Cytovance success
• Develop and transfer cell line process to upstream cell culture and to the Cytovance MST group for making Master cell banks.
• Draft and review Standard Operating Procedures (SOP’s)
• Draft and review Cell Line Protocols, Batch Records, Slide Deck Data Summaries and Reports.

• Support other Upstream Scientists or Analysts by assisting in USP troubleshooting measures and cross-review of results and notebooks
• Support additional R&D Services teams (CLD, Purification development and Analytical Development) by generation, review, and/or interpretation of CLD results
• Support Manufacturing groups be leveraging cell line expertise to support investigations and/or generation, review, and interpretation of cell culture results
• Operate, maintain, and qualify (I/O/PQ) laboratory equipment and software as required
• Specify, source, and assess new cell line technologies
• Perform data acquisition, reduction, and evaluation
• Specify and source new cell line equipment to expand the cell culture capabilities of the CLD laboratory
• Train others on CLD techniques and application
• Serve as a liaison with cell line subcontractors  

• Stay current with all training requirements.
• Follow procedures reliably and consistently.
• Establish good working relationships with peers and other colleagues.
• Display a positive attitude and good flexibility.
• Proactively ensure good lab hygiene is being practiced.
• Apply technical and scientific knowledge to the overall direction of projects. Enable Cytovance to use the most advanced technology available.  Acts as a scientific resource across disciplines.
• Make decisions that consistently require developing new options to solve complex problems.
• Use a high level of scientific judgment to adapt and/or create standard methods and techniques by applying breadth of knowledge and prior work experience.
• Work under minimal supervision. Exercise considerable latitude in determining the objectives of assignments.
• Identify and develop scientific strategies to support mid-term to long-term goals.
• Represent technological areas and Cytovance’s business perspectives at client project team meetings

Job Requirements:

• Ph.D. in Biotechnology, Microbiology, Cell Biology, Chemical Engineering, Biochemistry or related science, with a combination of ≥ 1 year of hands-on experience in CLD.  Previous work experience in CDMO is highly desirable.
• MS, in biochemistry or related science, with ≥3 years directly related experience in CLD.
• Has broad knowledge of principles, concepts, and practices with a range of analytical techniques including ELISA, HPLC, enzymatic, and electrophoresis (SDS-PAGE, Western blots, IEF, & CE) procedures.
•         Previous experience in the high-throughput robotic cell culture tools such as Namo cell, Cell metric, AMBR15, AMBR250, and or other high-throughput robotic systems.
•      Experience in Cell culture development using bioreactors at 1-50L scale (desirable)
• Good working knowledge of scientific and technologic disciplines within pharmaceutical sciences
• Good working knowledge of regulatory agencies and guidance documents governing GMP manufacturing such as ICH, FDA, and EMA.
• Able to communicate technical details of projects and project strategy to clients and Cytovance client team members

Physical Demands: 

While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to stand and sit. The employee is occasionally required to walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds.

Work Environment: 
 

While performing the duties of this Job, the employee is occasionally exposed to fumes or airborne particles and toxic or caustic chemicals consistent with a lab environment. The noise level in the work environment is usually moderate

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class.

Cytovance Biologics acknowledges that providers may be a valuable resource for identifying and recruiting Candidates for employment. However, we require that all external recruiters engage directly with Cytovance Biologics Human Resources Team and comply with Cytovance Biologic’s requirements prior to transmitting any Resumes/CV’s or introducing any candidates to an employee of Cytovance Biologics. Cytovance Biologic’s Human Resource Team is the only function within the Company that can enter contractual relationships with external recruiters and recruiting agencies.