- Subject matter expert for downstream process development. Working with external vendors to oversee, develop, and optimize downstream unit operations in a phase appropriate manner.
- Technical lead for downstream process tech transfer and manufacturing activities.
- Technical lead for downstream process characterization and PPQ with a risk-based approach.
- Develop experimental plans, oversee execution of experiments, and analyze data using statistical approaches as needed.
- Authors and reviews protocols, reports, batch records, and regulatory documents.
- Presents data and communicate plans at project team meetings.
- Leads troubleshooting and investigation of critical deviations.
- Supports CDMO selection.
- Collaborates with QA, Regulatory Affairs and other functions to generate/manage GMP and regulatory documents.
- Manage budget and accounting for drug substance work.
- MS/PhD in Chemistry, Biology, or Engineering discipline, with 5+ years (PhD) or 12+ years (MS) of related industry experience in biologics drug substance downstream development.
- Subject matter expert in biologics protein purification and downstream process development.
- Experience with large scale chromatography, ultrafiltration, viral inactivation and filtration.
- Experience with late phase downstream process characterization and PPQ.
- Working knowledge of upstream process development is nice to have.
- Experience overseeing external CRO based resources for production of drug substance.
- Experience and familiarity with successful operation in the biologics CMC regulatory environment for early to late-stage development.
- Familiarity and working knowledge of GMP/ICH regulations required with a quality mindset.
- Working knowledge of quality by design and risk management is strongly desired.
- Team oriented professional with excellent organizational, communication, leadership and problem-solving abilities.
- Demonstrated ability to successfully coordinate multiple work streams and development efforts efficiently.
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Process Development Specialist
12 hours ago
University of California San Francisco San Francisco, United StatesThe Department of Laboratory Medicine at the University of California, San Francisco(UCSF) is seeking a motivated and detail-oriented individual to join our Investigational Cellular Therapy (ICT) group. ICT aims to push the boundaries of medicine by developing, engineering, and m ...
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Process Development Engineer
2 days ago
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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Process Development Engineer
1 day ago
Dawar Consulting, Inc. Santa Clara, United StatesOur client, a world leader in diagnostics and life sciences, is looking Process Development Engineer based out of Santa Clara, CA. · Job Title: Process Development Engineer · Job Duration: Long Term Contract(Possibility Of Extension) · Location: Santa Clara, CA · Responsibilitie ...
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Process Development Engineer
20 hours ago
Dawar Consulting, Inc. Santa Clara, United StatesOur client, a world leader in diagnostics and life sciences, is looking for a Process Development Engineer based out of Santa Clara, CA. · Job Duration: Long Term Contract(Possibility Of Extension) · Responsibilities:Provide hands-on process support including troubleshooting and ...
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Scientist, Process Development
2 weeks ago
Cargo Therapeutics San Carlos, United StatesJob Description · Job DescriptionReporting to a lead within the Process Development team and with a focus on early development, CARGO is hiring a Process Development Scientist within the Process Sciences organization in Technical Operations. The candidate will contribute to and s ...
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Scientist - Process Development
16 hours ago
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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Process Development Associate 2
1 week ago
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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Research Associate, Process Development
1 day ago
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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Senior Director, Process Development
1 week ago
Cargo Therapeutics San Carlos, United States· The 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 successful candidate will have t ...
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Senior Director, Process Development
2 weeks ago
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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Process Development Engineer
2 weeks ago
Aether Biomachines Menlo Park, United States Full timeThis is an Exempt, Full Time position based in our Menlo Park, CA office (San Francisco, CA in the near future). This position reports to the Executive Vice President of Engineering of the Company. · Aether Biomachines is on a mission to build the post-scarcity future using pepti ...
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Scientist I/ii, Process Development
12 hours ago
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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Allakos Inc Redwood City, 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 ...
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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 ...
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Sr. Engineer, Process Development
2 weeks ago
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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Genomic Health, Inc. Redwood City, United States Full timePosition Overview · The Lead Engineer, Process Development and Automation leads, manages, implements, and provides technical engineering support for a variety of process automation hardware, software applications, and laboratory instruments. This position works and collaborates c ...
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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 ...
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Senior Process Engineer, Vector Development
1 week ago
Cargo Therapeutics San Carlos, United StatesReporting into a lead within the Vector Engineering/Development team depending on seniority, CARGO is hiring a downstream viral vector Process Development Senior Engineer on the Technical Operations team. The candidate will contribute to and support development of downstream GMP- ...
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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 - Lassen Therapeutics
Description
Job 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 Director to oversee downstream process development and manufacturing of early and late stage clinical biologics programs. In this role, you will report to our VP, CMC and join our growing, and highly-collaborative team.
Responsibilities:
Key Qualifications:
This position is an onsite, full time, direct hire role.
Lassen Therapeutics offers a competitive benefits package including medical, dental, vision and life insurance benefits for employees and their families. We also offer a 401(k) plan with a matching contribution, stock equity, unlimited time off and more.
Lassen is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation, veteran status, or any other protected category.
Associate Director, Downstream Process Development professionals in Redwood City
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Mark Davoren
Senior Sales Development Leader