Senior Manager/Manager, Downstream Process Development – 1701 - San Diego, CA | Biospace
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Senior Manager/Manager, Downstream Process Development – 1701

AnaptysBio, Inc.

San Diego, CA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Manager, Process Development,

Job Description

Position Summary

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


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