Associate Director, Downstream Process Development Join to apply for the Associate Director, Downstream Process Development role at Allakos Inc Associate Director, Downstream Process Development 3 weeks ago Be among the first 25 applicants Join to apply for the Associate Director, Downstream Process Development role at Allakos Inc 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.

While professional experience and qualifications are key for this role, make sure to check you have the preferable soft skills before applying if required.

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.Seniority level Seniority levelDirector Employment type Employment typeContract Job function Job functionResearch, Analyst, and Information Technology Referrals increase your chances of interviewing at Allakos Inc by 2x Sign in to set job alerts for “Director Process Development” roles. San Jose, CA $163,000.00-$339,500.00 6 days ago San Francisco, CA $160,000.00-$175,000.00 2 weeks ago Foster City, CA $180,000.00-$200,000.00 1 week ago San Francisco, CA $100,000.00-$140,000.00 3 months ago Director, Downstream Process DevelopmentDirector, Business & R&D Operations, Early Discovery San Mateo, CA $217,000.00-$301,000.00 2 weeks ago San Francisco, CA $175,000.00-$185,000.00 2 days ago San Leandro, CA $84,635.00-$111,716.00 5 days ago Santa Clara, CA $105,000.00-$130,000.00 2 days ago Foster City, CA $160,000.00-$200,000.00 4 days ago Director of Organizational Culture and Operations Oakland, CA $75,000.00-$87,500.00 1 week ago Director of Manufacturing, Advanced Process Technologies Sunnyvale, CA $179,800.00-$317,400.00 5 hours ago Director of Enterprise Programs, Process Development South San Francisco, CA $170,000.00-$240,000.00 5 days ago Director, Digital Innovation and Operations San Francisco, CA $152,500.00-$202,000.00 2 months ago Director, Airport Growth, Strategy, Operations & Partnerships San Francisco Bay Area $170,000.00-$190,000.00 2 weeks ago Director of Operations JN -072025-163631Director, Drug Product Development & ManufacturingDirector of Operations | Residential Real EstateDirector of Operations, Rules & Denials Automation Mountain View, CA $120,000.00-$190,000.00 1 month ago South San Francisco, CA $205,000.00-$229,000.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

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