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Associate Director, CMC Regulatory Affairs
Found in: Lensa US 4 C2 - 2 days ago
Mirum Pharmaceuticals San Mateo, United StatesMISSION · Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Propelled by our passion for patients and their families, we're focused on turning possibilities into realities. Using data and m ...
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VP/Senior Director, Regulatory Affairs
Found in: Lensa US 4 C2 - 5 days ago
TriArm Therapeutics San Mateo, United StatesBackground · TriArm Therapeutics is a clinical-stage biotechnology company that is advancing CAR T cellular therapy with novel platforms that are designed for enhanced safety, efficacy, and accessibility compared to conventional autologous CAR T therapies. Our key platform, Fast ...
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VP/Senior Director Clinical Operations
Found in: Appcast US C2 - 3 days ago
TriArm Therapeutics San Mateo, United StatesBackground · TriArm Therapeutics is a clinical-stage biotechnology company that is advancing CAR T cellular therapy with novel platforms that are designed for enhanced safety, efficacy, and accessibility compared to conventional autologous CAR T therapies. Our key platform, Fast ...
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VP/Senior Director Clinical Operations
Found in: Lensa US 4 C2 - 2 days ago
TriArm Therapeutics San Mateo, United StatesBackground · TriArm Therapeutics is a clinical-stage biotechnology company that is advancing CAR T cellular therapy with novel platforms that are designed for enhanced safety, efficacy, and accessibility compared to conventional autologous CAR T therapies. Our key platform, Fast ...
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VP/Senior Director Clinical Operations
Found in: Lensa US 4 C2 - 1 day ago
TriArm Therapeutics San Mateo, United StatesBackground · TriArm Therapeutics is a clinical-stage biotechnology company that is advancing CAR T cellular therapy with novel platforms that are designed for enhanced safety, efficacy, and accessibility compared to conventional autologous CAR T therapies. Our key platform, Fast ...
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VP/Senior Director Clinical Operations
Found in: Jooble US O C2 - 2 days ago
TriArm Therapeutics San Mateo, CA, United StatesBackground · TriArm Therapeutics is a clinical-stage biotechnology company that is advancing CAR T cellular therapy with novel platforms that are designed for enhanced safety, efficacy, and accessibility compared to conventional autologous CAR T therapies. Our key platform, Fast ...
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Associate Director, Clinical Supply Chain
Found in: Careerbuilder One Red US C2 - 3 days ago
Mirum Pharmaceuticals San Mateo, United StatesMISSION · Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Propelled by our passion for patients and their families, we're focused on turning possibilities into realities. Using data and ...
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Associate Director, Clinical Supply Chain
Found in: Lensa US 4 C2 - 2 hours ago
Mirum Pharmaceuticals San Mateo, United StatesMISSION · Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Propelled by our passion for patients and their families, we're focused on turning possibilities into realities. Using data and m ...
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Associate Director, Strategic Sourcing and Supplier Management, Primary Packaging Components
Found in: Talent US C2 - 2 days ago
Gilead Sciences Foster City, United States RegularJob Description · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therap ...
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Associate Director, CMC Regulatory
Found in: Lensa US 4 C2 - 3 days ago
Cargo Therapeutics San Carlos, United States· Reporting to the Vice President, CMC Regulatory, CARGO is seeking an Associate Director, CMC Regulatory to help progress development of our cell-based gene therapy portfolio. · The successful candidate will have a strong background in regulatory CMC with deep expertise in bio ...
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Associate Director, CMC Regulatory
Found in: Lensa US 4 C2 - 3 days ago
Cargo Therapeutics, Inc. San Carlos, United StatesReporting to the Vice President, CMC Regulatory, CARGO is seeking an Associate Director, CMC Regulatory to help progress development of our cell-based gene therapy portfolio. · The successful candidate will have a strong background in regulatory CMC with deep expertise in biologi ...
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Senior Director, CMC Launch Lead
Found in: Jooble US O C2 - 2 days ago
CARGO Therapeutics San Carlos, CA, United StatesReporting to the Head of CMC Strategy & Operations, CARGO Therapeutics is seeking a Senior Director, CMC Launch Lead within Technical Operations. This individual will lead a cross-functional CMC team focused on launch readiness of CARGO's lead autologous cell therapy asset CRG-02 ...
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Senior Director, CMC Launch Lead
Found in: Jooble US O C2 - 2 days ago
CARGO Therapeutics San Carlos, CA, United StatesReporting to the Head of CMC Strategy & Operations, CARGO Therapeutics is seeking a Senior Director, CMC Launch Lead within Technical Operations. This individual will lead a cross-functional CMC team focused on launch readiness of CARGO's lead autologous cell therapy asset CRG-02 ...
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Principal Engineer, Cell Therapy Process Development
Found in: Lensa US 4 C2 - 4 days ago
Cargo Therapeutics San Carlos, United States· Reporting into the Senior Director of Process Development, CARGO is hiring a Cell Therapy Process Development Principal Engineer within the Process Sciences organization in Technical Operations. The candidate will contribute to and support development of GMP-compatible manufac ...
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Senior Director, Process Development
Found in: Lensa US 4 C2 - 2 days ago
CARGO Therapeutics San Carlos, United StatesThe 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 tech ...
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Senior Director, Process Development
Found in: Lensa US 4 C2 - 2 days 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
Found in: Lensa US 4 C2 - 1 day ago
CARGO Therapeutics San Carlos, United StatesThe · 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 hav ...
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Senior Engineer, MSAT
Found in: Lensa US 4 C2 - 2 days ago
CARGO Therapeutics San Carlos, United States· CARGO is hiring a Senior Engineer, MSAT within the Technical Operations Manufacturing organization. This is a key role within the CARGO Manufacturing Organization focused on leading technology transfers for cell therapy processes, including supporting person-in-plant activitie ...
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Director, Quality Systems
Found in: Lensa US 4 C2 - 3 days ago
Cargo Therapeutics San Carlos, United States· CARGO Therapeutics is hiring a Director of Quality Systems & Compliance within the CMC Quality function of the Technical Operations business unit. Reporting to the Senior Director of Quality Assurance & Systems, this is a key role focused on building and managing a phase-appro ...
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research associate, process development
Found in: Careerbuilder One Red US C2 - 7 hours ago
Cargo Therapeutics, Inc. San Carlos, CA , USA, 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 ...
Executive Director, Cell Therapy CMC - San Mateo, CA, United States - BeiGene
Description
We are seeking an exceptional and highly motivated CMC leader to join the BeiGene Cell Therapy team to enable the cell therapy development. Ideal candidate must be proficient in both CMC strategic planning, execution, and matrix team management. The successful applicant will spearhead the management of GTP/GMP facility, while develop internal cell therapy CMC capability including required resources, budgets, technology needs to enable programs.
**Job Functions**
+ Strengthen internal cell therapy CMC capability by work with internal stakeholders and external partners to evaluate and enable cell therapy related GTP/GMP facility, along with delivering clinical material for cell therapy trials.
+ Develop a vendor selection strategy to select services for development and manufacturing of discovery and oncology early development clinical assets.
+ Plan, track, execute on programs from a pre-clinical stage through clinical proof of concept.
+ Lead cross-functional team to author CMC/ quality sections of regulatory submissions (INDs/CTDs).
+ Building scope and design of experiments as well as troubleshooting to generate robust GMP processes and analytics for cell therapy products.
+ Assembling relevant CMC data and authoring regulatory filing documents (CMC sections) and responses to questions from regulatory agencies. Routinely supporting release of GMP batches of cell therapy products.
+ Responsible for drug product management and generating and reviewing technical reports and technology transfer documents.
+ Ensures effective communication and collaboration of all involved functions and third parties.
+ Partnering and aligning with Discovery, Regulatory, Operations, Quality, and Clinical functions, and managing CMC-focused deliverables and timelines to move programs from lab to the clinic and beyond. Routinely presenting updates on CMC progress
**Qualification**
+ Doctoral degree in biochemical engineering, bioengineering, biotechnology, or relevant process development and manufacturing of biologics.
+ ?8 years of industrial experience in CMC of biologics. Experience with cell therapies is a plus.
+ Broad understanding of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies, distribution across multiple regions.
+ Excellent writing skills. Good understanding of iPSC related manufacturing processes and analytics is a plus
+ Experience authoring SOPs, regulatory and quality documents.
+ Experience working in cGMP manufacturing facilities and IND filing of biological products.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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