Associate Director, Downstream Process Development - San Diego, CA | Biospace
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Associate Director, Downstream Process Development

AnaptysBio, Inc.

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Location:
San Diego, CA
Posted Date:
3/9/2017
Position Type:
Full time
Job Code:
1701
Salary:
DOE
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

You will be responsible for directing technical activities for the process development and manufacturing of biologic drug substances, including:
•   Participating in and/or leading cross-functional project teams
•   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  
•   Participate in and/or lead cross-functional teams, and represent manufacturing development on various project teams responsible for meeting short and long-term organizational goals.  Provide insight and leadership into the development and coordination of strategic and tactical plans for drug substance development activities.  Establish and communicate key project milestones and critical decision points for endorsement by senior management; report regularly on progress and potential risks to program objectives.
•   As a CMC function leader, key responsibilities of the role include:
o   Provide technical direction and feedback to internal and external colleagues
o   Independently design, plan, prioritize and execute experiments and project related tasks
o   Maintain current knowledge of cGMP, industry standards and best practices
o   Ensure scalable, commercially-viable biological downstream manufacturing processes are properly developed, transferred, implemented and validated as necessary
o   Provide person-in-plant (PIP) support for critical manufacturing operations
o   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
o   Conduct deviation/OOS investigations, determine root cause, and implement appropriate CAPA
o   Manage budgets, schedules, and performance requirements to meet project/organizational goals
•   In conjunction with QA and RA, ensure all CMOs and 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

•   Ph.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
•   Excellent oral and written communication skills.  Ability to communicate clearly, and to report and present experimental results and analysis to department colleagues
•   Travel: Up to 25% of the time – occasional international travel to partner and contract facilities