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Downstream Process Development Manager Jobs in California

Kinetic Personnel Group

Downstream Process

Tustin, CA · On-site

This role will partner with Manufacturing, Process Development, Quality, and MSAT teams to analyze downstream purification process data, identify trends, optimize manufacturing performance, and ...

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Downstream Process Development Manager information

What is a downstream process development manager?

A Downstream Process Development Manager is a professional responsible for overseeing the development and optimization of downstream processes in biomanufacturing, particularly the purification and recovery of biological products after fermentation or cell culture. They lead teams in designing, scaling up, and validating processes such as filtration and chromatography to ensure product quality and regulatory compliance. These managers collaborate with cross-functional teams, manage timelines, and troubleshoot technical challenges to streamline production. Their role is critical in ensuring the efficiency and safety of biologic drug manufacturing.

What are the key skills and qualifications needed to thrive as a downstream process development manager, and why are they important?

To thrive as a Downstream Process Development Manager, you need a solid background in biochemistry, chemical engineering, or a related field, often with an advanced degree and industry experience in bioprocessing. Expertise in chromatography systems, filtration technologies, and statistical process control tools, along with familiarity with GMP regulations, is critical. Strong leadership, project management, and cross-functional communication skills help drive innovation and team performance. These competencies ensure efficient process development, regulatory compliance, and successful scale-up of biomanufacturing operations.

What are common challenges faced by downstream process development managers, and how can they be addressed?

Downstream Process Development Managers often encounter challenges such as optimizing purification processes for yield and purity, scaling up from lab to production, and troubleshooting process deviations. Addressing these issues requires strong collaboration with upstream teams, analytical departments, and manufacturing. Staying current with emerging technologies, maintaining robust documentation, and fostering a culture of continuous improvement are key to successfully overcoming these hurdles and ensuring efficient process transfer to manufacturing.

What are the most commonly searched types of Downstream Process Development jobs in California?

The most popular types of Downstream Process Development jobs in California are:

What cities in California are hiring for Downstream Process Development Manager jobs?

Cities in California with the most Downstream Process Development Manager job openings:

Director, Downstream Process Development

Redwood City, CA • On-site

Allakos
Biotechnology Research and Development • 51 - 200 employees
Learn more about Allakosexternal

Full-time

Re-posted yesterday

Job description

Director, Downstream Process Development
Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases.
Allakos is committed to developing innovative therapies that transform patients’ lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients.
Position Summary:
The Director, Downstream Process Development would be key member of Biologics DS development and tech transfer team and would be responsible for all activities related to Downstream Process Development of our late-stage clinical biologics (Mab) molecule AK002 and early stage program. This position leads the Purification Group which is responsible for the process development, tech transfer, supervision of Engineering and Clinical batches, BLA enabling activities, PPQ Batches and commercial production at multiple CMO sites, process characterization and BLA authoring and review.
Your Role:
  • Provide technical and managerial leadership to the Downstream Process Development group and technology transfer of AK002 process to CMO sites.
  • Accountable for all activities pertaining to the downstream process development lab. Supervise planning and execution of experiments. Analyze results and communicate it effectively to management.
  • Coordinate with Upstream development, Analytical and Facilities department to successfully complete the DSP activities
  • Provide overall strategy and experimental plan for downstream process characterization studies. Generate protocols, supervise execution, use statistical tools to analyze results and review reports for studies.
  • Plan the downstream process development experiments for new molecules and supervise execution of the same.
  • Supervise the Engineering and Clinical batches at the CMOs, Review and approve Batch records, Bill of Materials, Bill of Parameters, Batch records, deviations and CAPA documents for these batches
  • Plan and supervise PPQ batches at CMOs. Review and approve protocols and reports for PPQ batches
  • Author and review BLA submission documents
  • Lead cross functional meetings with Quality, Regulatory, Supply Chain, Process Development, Analytical and Drug Product to build consensus on key issues and facilitate decision making to move the project forward
  • Travel domestically and internationally up to 10% of the time
Qualifications and Expertise:
  • At least 15 years of relevant experience (12+ with MS, 10+ for PhD) successfully working in biopharmaceutical industry with proven track record of leadership and success
  • At least 8 years managing cross functional projects and leading teams
  • Extensive experience in Downstream process development and process characterization of biologics molecules such as Mabs and fusion proteins.
  • Experience in technology transfer and facility fit assessments
  • Should have worked with early and late stage and commercial biologics with experience in process development, process characterization, PPQ batches and other BLA enabling studies and CPV programs.
  • Experience working with Contract Manufacturers is preferred.
  • Experienced in BLA submission write ups.
  • Experience in people and stakeholder management, conflict resolution and building consensus.
  • Good understanding of cGMP-regulations including relevant US/EU regulatory and quality requirements, practices, and standards.
  • Exceptional interpersonal skills to establish positive relationships with internal stakeholders, CROs/CMOs, and multi-functional/multi-cultural teams.
  • Ability to travel at least 10% of the time.
The salary is competitive and commensurate with experience and qualifications.
The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership
Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or
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About Allakos

Sourced by ZipRecruiter

Industry

Biotechnology research and development

Company size

51 - 200 Employees

Headquarters location

Redwood City, CA, US

Year founded

2012

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