-
Regulatory Consultant/CMC, Cell/Gene Therapy
1 week ago
Pharmatech Associates San Francisco, CA, United StatesPharmatech is proud to be an equal opportunity employer. Together we are committed to fostering an environment that is professional, inclusive and diverse. Explore the exciting opportunities currently available in the US and around the world. · Regulatory Consultant/CMC, Cell/Ge ...
-
Executive Director, Cell Therapy CMC
1 week ago
BeiGene San Mateo, United StatesWe 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 spea ...
-
Abdera Therapeutics South San Francisco, United States**Who we are** · Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies · - one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform opt ...
-
Cmc Technical Writing Manager
1 week ago
Orca Bio Menlo Park, United StatesOver 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. · **Summary* ...
-
Senior Project Manager
1 week ago
Kyverna Therapeutics Emeryville, United StatesKyverna Therapeutics is a clinical-stage cell therapy company with the mission of engineering a new class of therapies for autoimmune diseases. The Kyverna therapeutic platform combines advanced T cell engineering and synthetic biology technologies to suppress and eliminate the a ...
-
Head of Regulatory Affairs, Oncology
1 week ago
Ascendis Pharma Palo Alto, United StatesHybridPalo Alto, California, United StatesOncology, Regulatory, OncologyFull time1404 · Description · We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we're advancing programs in Endocrinology Rare Disease, and Oncol ...
-
Sr. Research Associate, Potency Assays
1 week ago
4D Molecular Therapeutics Inc. Emeryville, United StatesSenior Research Associate will primarily focus on executing routine cell-based testing as per approved SOPs (QC-focused) for lot release/stability, comparability and formulation assessment of drug substances and drug products in accordance with cGMP standards, and contribute to d ...
-
sr. research associate, potency assays
1 week ago
BioSpace Emeryville, CA, United StatesJob Details · Attention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching ou ...
-
Kyverna Therapeutics Emeryville, United StatesKyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive ...
-
Kyverna Therapeutics Emeryville, United StatesKyverna Therapeutics is a clinical-stage cell therapy company with the mission of engineering a new class of therapies for autoimmune diseases. The Kyverna therapeutic platform combines advanced T cell engineering and synthetic biology technologies to suppress and eliminate the a ...
-
Sr. Financial Analyst, R&D Finance
1 week ago
4D Molecular Therapeutics Emeryville, United StatesAt 4D Molecular Therapeutics, Inc. ("4DMT"), we boldly innovate to unlock the full potential of genetic medicines for countless patients. We are committed to breaking boundaries and daring to cure as we develop new and foundational products and product components through our grow ...
-
Kyverna Therapeutics, Inc. Emeryville, United StatesKyverna Therapeutics is a clinical-stage cell therapy company with the mission of engineering a new class of therapies for autoimmune diseases. The Kyverna therapeutic platform combines advanced T cell engineering and synthetic biology technologies to suppress and eliminate the a ...
-
Kyverna Therapeutics, Inc. Emeryville, CA, United States Full timeKyverna Therapeutics is a clinical-stage cell therapy company with the mission of engineering a new class of therapies for autoimmune diseases. The Kyverna therapeutic platform combines advanced T cell engineering and synthetic biology technologies to suppress and eliminate the a ...
-
Scientist I
1 week ago
4D Molecular Therapeutics Emeryville, United States Full timeAttention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to h ...
-
Sr. Research Associate, Potency Assays
1 week ago
4D Molecular Therapeutics Emeryville, United States Full timeAttention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to h ...
-
Regulatory Operations Manager
1 week ago
Caribou Biosciences Berkeley, United StatesCaribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therap ...
-
Exelixis Inc. Alameda, United StatesSUMMARY/JOB PURPOSE: · The incumbent will be responsible for the day-to-day activities directed to support development and manufacturing of biological (antibody drug conjgates, mAbs, bispecifics) drug products (DP). The activities include formulation development, DP manufacturing ...
-
Sr. Director, Regulatory Affairs
1 week ago
Scribe Therapeutics Alameda, United StatesScribe Therapeutics is a molecular engineering company focused on creating best-in-class in vivo therapies that permanently treat the underlying cause of disease. Founded by CRISPR inventors and leading molecular engineers Benjamin Oakes, Brett Staahl, David Savage, and Jennifer ...
-
Dennis Partners San Francisco, CA, United StatesThis clinical-stage biotechnology company is developing potentially curative therapies for heart disease. They are seeking a Regulatory CMC Executive Director or Senior Director to lead CMC Regulatory strategies and execution for their portfolio of programs. Reporting into the SV ...
-
Director CMC
1 week ago
EPM Scientific San Francisco, United StatesDirector of CMC · Location : San Francisco, CA · Working situation : Hybrid · Level : Director · Our client, a blooming biotechnology company, is looking to expand their R&D capacity to support their growing pipeline including a new class of brain therapies. With a passion for tr ...
Executive Director, Cell Therapy CMC - Emeryville, 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.
#J-18808-Ljbffr
