- Editas Medicine (Cambridge, MA)
- …with more than one modality including biologics, small molecules, nucleic acid-based, or gene therapy products; and possess a solid understanding of FDA/EMA ... maintaining high quality performance. Key Responsibilities: As the Senior Director , In Vivo Gene Editing Therapeutics, you...Familiarity with FDA and EMA guidance for cell and gene therapy and experience with IND-filing. +… more
- Kelly Services (Burlington, MA)
- …high growth CRO environment serving leading pharma in biologic development and cell & gene therapy . This is a unique opportunity to join a dynamic team ... **Sr. Manager/ Associate Director - Quality Assurance** **Burlington, MA** **Direct Hire**...packages and reports to the Company's external pharma and gene therapy partners. + Ensure appropriate definition,… more
- Editas Medicine (Cambridge, MA)
- …regulation of biologics is essential; experience with gene editing and/or cell and gene therapy is preferred. + A broad understanding of the drug product ... allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at the core of everything we do,… more
- Editas Medicine (Cambridge, MA)
- …CRO industry + Experience in Rare Disease Drug Development and familiarity with gene and/or cell therapy preferred + Significant end-to-end, hands-on experience ... the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at the...Position Summary Reporting to the VP of Biometrics, the Director /Sr. Director , Clinical Data Management is responsible… more
- Editas Medicine (Cambridge, MA)
- …15+ years of experience in global supply chain from pharma, biotech or cell & gene therapy companies + Passion for patients, collaborative and effective leader + ... the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at the...materials at all locations. Key Responsibilities: As the Sr. Director , Supply Chain, you will be responsible for: +… more
- Astellas Pharma (Westborough, MA)
- ** Director , Manufacturing Operations** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven ... embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a… more
- Sanofi Group (Cambridge, MA)
- …areas such as In-vitro diagnostics, IV at home, and targeted delivery systems for Gene therapy . The successful candidate will be responsible for leading and ... at home, in-vitro diagnostic devices, and targeted non-systemic delivery systems for gene therapy . **Business Development Liaison:** + Collaborate with business… more
- Catalent Pharma Solutions (Chelsea, MA)
- …regulatory strategy for product development and manufacturing activities for the Cell & Gene Therapy sites to ensure compliance with GMP regulations and to ... **Associate Director , Regulatory Affairs** **Position Summary:** Catalent is a...and filing of regulatory submissions for clients. The **Associate Director , Regulatory Affairs** will be interpreting and evaluating reports… more
- Astellas Pharma (Westborough, MA)
- …embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a ... (SME) for Mfg. Operations. **Organizational Context:** Report directly to Director of Manufacturing Science and Technology (MS&T) or delegate. **Qualifications:**… more
- Harvard University (Cambridge, MA)
- …directors. + Facilitate and contribute to development of a new course in cell and gene therapy based on modern best teaching practices. + Contribute to the TGP's ... and Global Programs, and Dr. Aimee Hollander, the Curriculum Fellows Program Director . The primary responsibilities of the TGP Curriculum Fellow are expected to… more