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- Job Type: Full-Time
- Function: Research Sci/Assoc/Mgr
- Industry: Biotechnology
- Post Date: 10/07/2024
- Email: joinus@nurabio.com
- Website: nurabio.com
- Company Address: 161 Oyster Point Blvd, South San Francisco, California, 94080
- Salary Range: $50,000 - $150,000
About Nura Bio
At Nura Bio (previously known as Proneurotech Inc.), we envision a world where the diagnosis of a neurological disorder comes with the hope of a cure. Expanding on recent breakthroughs in crucial neurodegenerative pathways, we are positioned to deliver transformative neuroprotective therapies to prevent and protect against neuronal loss and related neuroimmune dysregulation.Job Description
Nura Bio, Inc. (Nura Bio) is a clinical-stage biopharmaceutical company developing neuroprotective therapies for the treatment of a broad range of neurological diseases. Nura Bio’s research and early development small molecule pipeline is focused on developing therapies that halt axon degeneration and/or modulate microglial responses to degeneration and injury, with the goal of conferring neuroprotection, across diseases of the central, peripheral, and ocular nervous system.
We are seeking a highly motivated and skilled individual with skills and experience in the Chemistry, Manufacturing, & Controls (CMC) area to join our team of dedicated scientists. As a Director of CMC, you will be a key member of the drug development team.
Nura Bio offers a comprehensive generous medical and dental insurance, vision, life and disability insurance, health savings account, flexible savings, and dependent care, 401(k) plan, and highly attractive stock options.
Nura Bio is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
To learn more about our mission and our science, visit us at www.nurabio.com. If you have the experience we are seeking and would like the opportunity to contribute to our mission, we would like to hear from you!
Please send your CV with a cover letter delineating why you are interested to joinus@nurabio.com
Key Responsibilities:
The Director of CMC, reporting to Sr. Vice President of Development Sciences, will lead the CMC function and oversee the execution of CMC activities of small molecule therapeutics in development. The CMC activities include development of chemical processes for and manufacturing of drug substances, formulation development and product manufacturing, and management of clinical trial materials (CTMs). This individual will also contribute to discovery pharmaceutics and assist with the selection of development candidates. Specific responsibilities include, but are not limited to the following,
- Plan and manage development of chemical process for and manufacturing of drug substance, formulation development and product manufacturing, CTM activities, and development and validation of analytical methods for drug substance and product
- Oversee release testing of drug substance, CTMs; review and QC testing results; work with others to resolve any manufacturing or analytical issues
- Oversee stability studies of drug substance and drug product, including review and approval of stability protocol, stability data and reports
- Provide technical input to and/or create specifications for drug substance and drug product; recommend and justify retest date and/or shelf life of drug substance and drug product
- Write and/or review the CMC section of regulatory filing
- Address CMC-related issues in meetings and correspondences with regulatory agencies
- Function as an in-house expert in one or more of the sub-CMC areas: drug substance, drug product, CTMs or analytical sciences
- Provide early pharmaceutics and formulation input to discovery project teams
- Other project support as needed
Skills & Qualifications:
- Ph.D. in chemistry or pharmaceutical sciences with minimum 10 years of experience in the CMC of small molecule therapeutics. M.S. and B.S. in chemistry or pharmaceutical sciences with proper and adequate experience will be considered
- In-depth knowledge and experience in at least one of the following areas: analytical sciences, drug substance or drug product
- Knowledge and understanding of GMP and GXP guidelines and regulatory requirements with respect to drug substance, drug product and/or CTMs
- A track record of management of CMC activities internally and externally
- Ability of strategic thinking, problem-solving, working independently
- Well-organized, attention to detail, and enthusiasm to collaborate with other team members
- Effective and efficient verbal and written communications