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Associate Director Downstream Process Development Jobs

Legend Biotech USA, Inc.

Role OverviewThe Principal Engineer, Lentivirus Downstream Process Development, will be a key ... Direct the translation of bench-scale processes to GMP manufacturing by simulation plus wet lab ...

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How much do associate director downstream process development jobs pay per hour?

As of Sep 9, 2026, the average hourly pay for associate director downstream process development in the United States is $33.68, according to ZipRecruiter salary data. Most workers in this role earn between $27.64 and $41.35 per hour, depending on experience, location, and employer.

What does an associate director downstream process development do?

An Associate Director of Downstream Process Development leads teams responsible for developing, optimizing, and scaling up purification processes for biologics or pharmaceuticals after the initial production phase. They oversee activities such as chromatography, filtration, and formulation to ensure that products meet quality, safety, and regulatory standards. This role involves strategic planning, cross-functional collaboration, troubleshooting, and ensuring that the processes are efficient and compliant for large-scale manufacturing. Additionally, they mentor junior staff, manage budgets, and often interact with regulatory agencies.

What are the key skills and qualifications needed to thrive as an associate director downstream process development?

To thrive as an Associate Director Downstream Process Development, you need advanced knowledge in bioprocess engineering, protein purification, and a relevant advanced degree (typically Ph.D. or M.S.) in biochemistry or a related field. Experience with chromatography systems, process analytical technologies (PAT), and regulatory compliance (GMP) is typically required. Strong leadership, project management, and cross-functional communication skills help drive team performance and successful technology transfer. These skills and qualities are essential to ensure efficient development, scale-up, and regulatory approval of biopharmaceutical products.

What are some of the primary challenges faced by an associate director downstream process development, and how can they be addressed?

One of the main challenges in this role is overseeing the scale-up and transfer of downstream bioprocesses from development to manufacturing while maintaining product quality and meeting regulatory requirements. This often involves troubleshooting process inconsistencies, adapting to evolving project priorities, and ensuring effective cross-functional communication with teams such as upstream development, quality assurance, and manufacturing. Success in this position relies on strong leadership, proactive risk management, and the ability to mentor and guide team members through complex technical and operational issues.

What are popular job titles related to Associate Director Downstream Process Development jobs?

For Associate Director Downstream Process Development jobs, the most frequently searched job titles are:

Infographic showing various Associate Director Downstream Process Development job openings in the United States as of September 2026, with employment types broken down into 1% Internship, 1% As Needed, 82% Full Time, 14% Part Time, and 2% Contract. Highlights an 87% Physical, 2% Hybrid, and 11% Remote job distribution, with an average salary of $70,060 per year, or $33.7 per hour.

Associate Director, Downstream Process Development

Redwood City, CA

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

Full-time

Re-posted 11 days ago

Job description

Associate 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:
As a member of the Allakos team you will have the opportunity to be a key member of the Biologics DS development and Tech Transfer team and responsible for activities related to Downstream Process Development of our late-stage clinical biologic (Mab) molecule AK002 and other early-stage programs. This position will be responsible for the Process Development, Tech Transfer, and oversite of Engineering/Clinical batches at contract manufacturing site/s. Additionally, there will be a strong focus on BLA-enabling activities including process characterization, PPQ Batches and BLA authoring and review.
Your Role:
  • Provide technical leadership to the Downstream Process Development group and technology transfer of AK002 process to CMO sites.
  • Accountable for activities pertaining to the downstream process development lab. Supervise planning and execution of experiments. Analyze results and communicate them effectively to management.
  • Coordinate with Upstream Development, Analytical, and Facilities departments to successfully complete the DSP activities.
  • Provide input for the strategy and experimental plan for downstream process characterization studies. Generate protocols, supervise execution, use statistical tools to analyze results, and review reports for studies.
  • Assist in the planning of downstream process development experiments for new molecules and supervise execution of the same.
  • Supervise the Engineering and Clinical batches at CMOs, review and approve Deviations and CAPA documents for these batches.
  • Plan and supervise PPQ batches at CMOs. Review and approve protocols and reports for PPQ batches.
  • Author BLA submission documents.
  • Travel domestically and internationally up to 10% of the time.
What We Value:
  • At least 12 years of relevant experience (10+ with M.S., 8+ for Ph.D.) successfully working in the biopharmaceutical industry with proven track record of leadership and success.
  • At least 5 years managing cross functional projects and leading teams.
  • Extensive experience in Downstream Process Development and process characterization of biologics, such as Mabs and fusion proteins.
  • Strong background in statistical design of experiments (DoE) and associated analysis
  • Experience in technology transfer and facility fit assessments.
  • Should have worked with late and commercial stage 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.
  • Experienced 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 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 civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
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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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