Senior Manager/Manager, Downstream Process Development - San Diego, CA | Biospace
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Senior Manager/Manager, Downstream Process Development

AnaptysBio, Inc.

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Location:
San Diego, CA
Posted Date:
7/24/2017
Position Type:
Full time
Job Code:
1701
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Manager, Process Development,

Job Description


This position is responsible for directing technical activities for the process development and manufacturing of biologic drug substances, including:

•   Downstream process development (mammalian expression system)
•   Technology transfer and oversight of CMO manufacturing
•   Author, review and approval of technical reports
•   Review and approval of GMP documents
•   Author and review CMC sections of regulatory submissions

Essential Functions

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

•   Participate in and/or lead cross-functional teams, and represent downstream development function on various project team
•   Ensure scalable, commercially-viable biological downstream manufacturing processes are properly developed, transferred, implemented and validated as necessary
•   Provide person-in-plant (PIP) support for critical manufacturing operations
•   Oversee the creation/approval of cGMP-compliant documentation (master batch records, SOPs, etc.), as well as the post-manufacturing review and close-out of executed batch records
•   Conduct deviation/OOS investigations, determine root cause, and implement appropriate CAPA
•   In conjunction with QA and RA, ensure all CMOs and downstream processes are compliant with the applicable Corporate, Quality and Regulatory requirements and regulations
•   Author and/or review appropriate sections of regulatory filings. Apply advanced technical writing skills to produce reports and documents; writes independently and evaluates the writing of others

Requirements


Education & Experience

•   D. degree in life sciences, chemical engineering, biochemical engineering or related relevant field and 5+ years of relevant industry experience or BS/MS degree and 8+ years of experience.
•   Demonstrated technical proficiency in biologic drug substance processes (particularly monoclonal antibodies); expert in downstream purification operations such as centrifugation, filtration, UF/DF, chromatography, viral inactivation and viral filtration from pilot to Phase 3/commercial scale
•   Experience in setting process and product specifications
•   Direct experience preparing and reviewing CMC documentation for regulatory filings and inspections
•   Demonstrated success in leading development-stage, cross-functional project teams

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