- 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.
- 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.
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Dawar Consulting, Inc. Santa Clara, United StatesOur client, a world leader in diagnostics and life sciences, is looking Process Development Engineer. Kindly have a look at the details below and let us know if you are interested. · Job Title: Process Development Engineer · Job Duration: Long Term Contract(Possibility Of Extensi ...
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Elegen San Carlos, United StatesJob Description · Job DescriptionElegen is blazing a path towards a biology-based economy with a highly innovative approach to DNA synthesis that delivers an industry leading length of 7kb in 7 business days with a 99.999% per base accuracy. Our multidisciplinary team of best-in- ...
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corbion South San Francisco, United StatesAt Corbion, we exist to champion preservation in all its forms, preserving food and food production, health, and our planet. · **RESPONSIBILITIES**: · - Hands-on role in the setup, operation, and cleaning of bench and pilot scale equipment, with focus on downstream recovery proce ...
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Third Rock Ventures San Carlos, United StatesReporting to a lead within the Process Development team, CARGO is hiring a Process Development Research Associate within the Process Sciences Organization in Technical Operations. The candidate will contribute to and support development of GMP compatible manufacturing processes f ...
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Cargo Therapeutics San Carlos, United StatesJob Description · Job DescriptionThe Senior Director of Process Development is responsible for managing the high performing organization, people, processes, procedures, business strategies, and the overall continuous building of a proficient Process Development department. The su ...
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AbbVie South San Francisco, United States**Company Description** · **Key Accountabilities/Core Job Responsibilities** · - Perform routine tasks such as media/buffer preparation, thawing of cryopreserved cells, cell culture passaging, aseptic sampling and banking competently and independently to support ongoing projects ...
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Allakos Redwood City, CA, United StatesAssociate 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 d ...
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Lassen Therapeutics Redwood City, United StatesJob Description: Associate Director, Downstream Process Development · Lassen Therapeutics is a therapeutic antibody discovery and development company dedicated to the identification of novel medicines for serious unmet medical needs. We are currently looking for an Associate Dire ...
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Orca Biotech Menlo Park, United States Full timeOver one million people in the world today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many patients, the transplant itself can prove fatal or lead to serious conditions, such as graft versus host disease. · Orca Bio's ...
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Vaxcyte, Inc. San Carlos, United States Full timeJoin our Mission to Protect Humankind · Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to er ...
Associate Director, Downstream Process Development - Redwood City, United States - Allakos Inc
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:
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.
Associate Director, Downstream Process Development professionals in Redwood City
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Mark Davoren
Senior Sales Development Leader