Senior Director, CMC - Durham, NC

We are passionate about premier science and the impact it has on our world. · Provide strategic and managerial oversight of Chemistry, Manufacturing and Controls (CMC) operations including overseeing pharmaceutical laboratory method development, · validation · ,and sample analysi ...

+ Job summary At BioAgilytix we are passionate about premier science and the impact it has on our world Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services We are ...

Job Title: Director Process Development and Manufacturing, CMC · Department: CMC · Reports to: Chief Technical Officer · About the Company:   · Opus Genetics is committed to building an innovative, efficient and sustainable science based and commercial ophthalmic biopharmaceuti ...

Job Title: Director Process Development and Manufacturing, CMC · Department: CMC · Reports to: Chief Technical Officer · About the Company: · Opus Genetics is committed to building an innovative, efficient and sustainable science based and commercial ophthalmic biopharmaceutic ...

The Associate Director/Director, Regulatory CMC reports to the Vice President of Regulatory CMC and is responsible for managing the Company's Regulatory CMC function to enable clinical development, marketing authorization, manufacture, and distribution of clinical supplies and co ...

About This Role · As Associate Director, Regulatory CMC Small Molecule Lead, you will play a pivotal role in shaping and executing the global Regulatory Chemistry, Manufacturing and Controls (RegCMC) strategy for Biogen's small molecule portfolio. You will be responsible for lea ...

The Associate Director Regulatory Affairs – CMC is responsible for preparing regulatory submissions to support clinical development registration lifecycle management assigned project including small molecules drug-device combinations. · ...

The Associate Director is responsible for preparing and managing regulatory CMC submissions to support clinical development registration and lifecycle management for assigned project including small molecules inhaled therapies and drug-device combinations. · Contributes to the gl ...

The Senior Director, CMC Global Regulatory Affairs is responsible for leading all regulatory CMC development, registration, and compliance activities from early development through commercialization. · Lead development of CMC and device regulatory submission strategies by working ...

Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary hyperte ...

The Associate Director, Regulatory CMC Small Molecule Lead will play a pivotal role in shaping and executing the global Regulatory Chemistry, Manufacturing and Controls (RegCMC) strategy for Biogen's small molecule portfolio. · ...

Company Description · Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your a ...

As the Senior Director, Global Regulatory CMC - Drug-Device Combination Products, you will serve as the enterprise regulatory leader for our global device and combination product portfolio. · ...

Job Title: Director of Analytical Sciences & Technology, CMC · Department: CMC · Reports to: Chief Technology Officer · About the Company: · Opus Genetics is committed to building an innovative, efficient and sustainable science based and commercial ophthalmic biopharmaceutica ...

We are seeking an experienced Associate Director of Quality Operations to support and strengthen a rapidly growing pre‑clinical and clinical gene therapy programs. · The ideal candidate will bring deep GXP Quality Assurance experience across clinical, CMC, and non‑clinical functi ...

Piper Companies is seeking a Manager of Quality Operations to join an innovative organization in the biotech and gene therapy industry for a permanent position in Durham, NC. · ...

Piper Companies seeks a Manager of Quality Operations to join an innovative biotech and gene therapy organization in Durham NC for a permanent position. The Manager will support GXP quality efforts across pre-clinical and clinical programs. · ...

+We are seeking a Senior Director, Procurement to build lead and scale our procurement function. · +Develop and own the enterprise-wide procurement strategy aligned with Business Owners Finance Legal and Quality · +In coordination with Business Owners Legal & QA support end-to-en ...

Definium Therapeutics is seeking a Senior Director, Procurement to build and scale its procurement function. · ...

The Senior Scientist, Analytical Development will provide the design, development, qualification and execution of analytical assays to support product and process characterization. · Design biochemical assays such as ELISAs. · Evaluate CRO/CMO test results. · ...