Belite Bio, Inc.
Sr. Manager / Associate Director, CMC
Belite Bio, Inc., San Diego, California, United States, 92189
Belite Bio (NASDAQ: BLTE) is a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical need, such as STGD1 and GA in advanced dry AMD, in addition to specific metabolic diseases. Belite’s lead candidate, Tinlarebant, an oral therapy intended to reduce the accumulation of bisretinoid toxins in the eye, is currently being evaluated in a Phase 3 study (DRAGON) and a Phase 2/3 study (DRAGON II) in adolescent STGD1 subjects and a Phase 3 study (PHOENIX) in subjects with GA.
Role Description This is a full‑time role for a Sr. Manager / Associate Director, CMC located in San Diego County, CA. This position is responsible for leading the tech transfer, manufacture, release, and stability of drug substance/drug product and analytical activities to support drug development through late‑stage commercialization of our lead compound. The role also includes supporting qualification and process validation activities related to manufacturing operations while managing the drug supply chain by efficient planning, proficient project management across a multidisciplinary team in a hands‑on, fast‑paced culture.
Responsibilities
Evaluate CDMO’s capabilities working with Quality Assurance and Regulatory Affairs and assist in negotiating effective supply/technical agreements.
Effectively manage selected CDMO facilities, domestic and foreign, leading a multidisciplinary team for small molecule drug substance (API) and drug product manufacturers for continuous improvements.
Lead technical evaluation and optimization activities for drug substance development including scale‑up, design‑space studies, fate and purge studies, process validation through commercial launch activities.
Review and approve master and executed batch records, analytical release testing, specification setting, stability studies and investigations.
Ensure compliance with cGMP regulations working with quality assurance including deviations, OOS, batch record reviews, and lot disposition.
Develop, support and author global regulatory CMC strategy in partnership with other departments to create and organize successful IND, NDA, MAA, and other global applications.
Participate in representing the regulatory CMC group at health authority meetings and interactions, including FDA, EMA, and others as required.
Organize and maintain document folders for all CMC‑related documents in a validated Global QMS system.
Assist in creating timelines and budgets, track proposals and invoices to ensure alignment with approved CMC budget and timelines.
Qualifications
BS or Master’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field, with 10+ years of experience in CMC small molecule development (or equivalent industry experience for those with a Ph.D.).
Strong knowledge of cGMP regulations, ICH guidelines, CMC practices across OSD manufacturing and analytical chemistry.
Proven track record in successful CMC regulatory submissions (IND, NDA, MAA) on a global scale.
Knowledge of quality‑by‑design (QbD) principles, statistical analysis, and DOE for NDA, MAA submissions.
Experience leading CMO teams and overseeing all technology transfer processes.
Excellent problem‑solving, project management, and oral and written communication skills.
Ability to work collaboratively and self‑motivated in a fast‑paced work environment.
Willingness to travel as needed (up to 15%).
Seniority level Director
Employment type Full‑time
#J-18808-Ljbffr
Role Description This is a full‑time role for a Sr. Manager / Associate Director, CMC located in San Diego County, CA. This position is responsible for leading the tech transfer, manufacture, release, and stability of drug substance/drug product and analytical activities to support drug development through late‑stage commercialization of our lead compound. The role also includes supporting qualification and process validation activities related to manufacturing operations while managing the drug supply chain by efficient planning, proficient project management across a multidisciplinary team in a hands‑on, fast‑paced culture.
Responsibilities
Evaluate CDMO’s capabilities working with Quality Assurance and Regulatory Affairs and assist in negotiating effective supply/technical agreements.
Effectively manage selected CDMO facilities, domestic and foreign, leading a multidisciplinary team for small molecule drug substance (API) and drug product manufacturers for continuous improvements.
Lead technical evaluation and optimization activities for drug substance development including scale‑up, design‑space studies, fate and purge studies, process validation through commercial launch activities.
Review and approve master and executed batch records, analytical release testing, specification setting, stability studies and investigations.
Ensure compliance with cGMP regulations working with quality assurance including deviations, OOS, batch record reviews, and lot disposition.
Develop, support and author global regulatory CMC strategy in partnership with other departments to create and organize successful IND, NDA, MAA, and other global applications.
Participate in representing the regulatory CMC group at health authority meetings and interactions, including FDA, EMA, and others as required.
Organize and maintain document folders for all CMC‑related documents in a validated Global QMS system.
Assist in creating timelines and budgets, track proposals and invoices to ensure alignment with approved CMC budget and timelines.
Qualifications
BS or Master’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field, with 10+ years of experience in CMC small molecule development (or equivalent industry experience for those with a Ph.D.).
Strong knowledge of cGMP regulations, ICH guidelines, CMC practices across OSD manufacturing and analytical chemistry.
Proven track record in successful CMC regulatory submissions (IND, NDA, MAA) on a global scale.
Knowledge of quality‑by‑design (QbD) principles, statistical analysis, and DOE for NDA, MAA submissions.
Experience leading CMO teams and overseeing all technology transfer processes.
Excellent problem‑solving, project management, and oral and written communication skills.
Ability to work collaboratively and self‑motivated in a fast‑paced work environment.
Willingness to travel as needed (up to 15%).
Seniority level Director
Employment type Full‑time
#J-18808-Ljbffr