Senior Manager, Upstream Process Development-1712 - San Diego, CA | Biospace
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Senior Manager, Upstream Process Development-1712

AnaptysBio, Inc.

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Location:
San Diego, CA
Posted Date:
7/10/2017
Position Type:
Full time
Job Code:
1712
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Manager, Process, Process Development,

Job Description


Position Summary

This position is responsible for managing upstream process development and subsequent manufacturing of biological products at contract manufacturing organizations. Management of CMOs and CROs is a critical aspect of the job and will include frequent visits to the contractors depending on the intensity of the ongoing activities. The role involves significant cross functional collaboration with other functions, including cell line, downstream, analytical, quality assurance and regulatory departments.

Essential Functions

These may include, but are not limited to, the following; other duties may be assigned:

•   Manage and support upstream process development, scale-up, production and tech transfer of processes within or between CMOs.
•   Ensure all experiments and activities are documented appropriately to ensure full traceability of work performed at the CMO/CRO.
•   Contribute to preparation and submission of CMC portions of regulatory submissions and updates (IND and BLA)
•   Will design, manage and support process characterization studies and develop control strategies for process validation.
•   Support process investigations and help determine root cause of excursions in clinical manufacturing.
•   Work effectively with team members and contractors both in-person and remotely.  Provide direction, support, and corrective action as needed.
•   Ensure that all processes are in line with health, safety, environmental and quality requirements including regulations, policies, applicable guidelines and procedures.

Requirements


Qualifications

Education & Experience:

•   PhD in Biochemistry / Biology / Chemical Engineering, with 5+ years of biological process development and manufacturing experience with a strong record of achievement; or BS/MS degree and 8+ years of relevant experience.
•   Proven hands-on experience with mammalian bioreactors as well as centrifugation and depth filtration.
•   Demonstrated experience in tech transfer of a process from development to manufacturing or between manufacturing sites.
•   Demonstrated, in-depth understanding of environmental, nutritional and mechanical factors influencing cell growth, productivity and stability.
•   Working knowledge of CMC regulatory requirements for biological pharmaceutical products at various stages of development

Personal Competencies:

•   Excellent oral and written communication skills. Ability to communicate clearly, and to report and present experimental results and analysis to department colleagues
•   Self-motivated, independent, and results-oriented and team player
•   Travel: Up to 20% of the time – occasional international travel to partner and contract facilities