- Insmed Incorporated (Bridgewater, NJ)
- …preferred.Minimum of 10 years of experience as a regulatory toxicologist (study director /monitor and/or project lead ) in the pharmaceutical or biotechnology ... preferred.Minimum of 10 years of experience as a regulatory toxicologist (study director /monitor and/or project lead ) in the pharmaceutical or biotechnology… more
- Editas Medicine (Cambridge, MA)
- …regulatory success, and proposing risk mitigation measures. + Serve as a Regulatory CMC lead on relevant cross-functional or functional teams to provide ... with applicable EMA/FDA/ICH/WHO/Global regulations and regulatory guidance and guidelines. + Lead CMC related interactions with the health authorities including… more
- University of Pennsylvania (Philadelphia, PA)
- …health and wellness programs and resources, and much more. Posted Job Title Director , Clinical Development ( Gene Therapy Program) Job Profile Title Director ... in the gene therapy space. Currently we are positioned to lead another round of vector innovation and establish preclinical and clinical proof-of-concept in… more
- Sumitomo Pharma (Columbus, OH)
- …management of the global contract testing laboratories in partnership with the Company's CMC Team. The Associate Director also participates in drafting and ... **Associate Director , GMP Quality Control** Sumitomo Pharma America (SMPA)...oncology, urology, women's health, rare disease, and cell & gene therapies. The company's diverse portfolio includes several marketed… more
- Editas Medicine (Cambridge, MA)
- …Chain and Technical Operations and partner with leadership in TechOps, ClinOps, Finance, CMC and Program Teams to lead short-term integrated production and raw ... 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
- Lilly (IN)
- …Lilly to discover and develop novel biologic, small molecule, nucleic acid, and gene -based therapeutics. Our focus is the patient: by understanding the biology and ... record of delivering impactful medicines that improve people's lives. As Senior Director DOCTA External Innovation, this role will help develop and implement Eli… more
- Astellas Pharma (Sanford, NC)
- …information on Astellas, please visit our website at **www.astellas.com** . **About Astellas Gene Therapies** Astellas Gene Therapies is an Astellas Center of ... their newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy,… more
- Bristol Myers Squibb (Seattle, WA)
- …lives. Read more: careers.bms.com/working-with-us . Position Summary: The Associate Director Supplier Relationship Manager (SRM) is accountable for overall ... BMS vision. The SRM acts as a manufacturing site lead and is accountable for the performance of the...managed to assure robust supply of BMS cell and gene therapy products. The SRM must have proven experience… more
- Lilly (Indianapolis, IN)
- … to develop manufacturing process control strategies for clinical and commercial products. + Lead the preparation of the CMC portion of the IND/CTA/BLA/NDA. + ... in Oligonucleotide development, nanomedicines for tissue specific targeting and other gene delivery strategies. The drug product team is also investing in… more
