Imara is seeking to fill a CMC, Drug Product position to manage the clinical supply needs of the IMR-687 development program This position reports to the VP of Technical Operations and works with the Imara team and will be responsible for designing phase-appropriate formulations and manufacturing small molecule drug candidates completely through external CDMOs. In addition, this person will develop and lead the validation process for Imara’s drug products as the company moves toward commercialization. The successful candidate will be skilled at understanding the needs of time sensitive programs with the ability to manage workload and meet project timelines for multiple formulations in parallel development.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Lead all activities related to the development and manufacture of the formulations in development.
- Work with Imara’s technical staff and consultants to develop phase appropriate formulation plans that support the clinical trial needs of the company.
- Work with Supply Chain and Clinical Operations to ensure timely delivery of IMP
- Work with Quality Assurance to audit and qualify vendors for manufacturing activities.
- Develop budget and timelines for DP efforts based on clinical trial design and overall development plans
- Lead the operational meetings with third party drug product CROs.
- Prepare and update regulatory filings as necessary
- MS in Chemistry, pharmaceutics, or related life sciences field
- PhD in Chemistry, Pharmaceutics, or related life sciences field preferred
Experience, Knowledge, Skills and Abilities
- Minimum of 10 years’ biopharmaceutical industry experience in CMC and expertise in solid oral formulation and modified release
- Experience in pediatric formulation development preferred
- Management of third-party CRO/CMO partners and associated service providers and consultants
- Demonstrated abilities and hands-on experience in drug product and lead optimization phase through registration with a focus on phase 3 through registration
- Ability to evaluate development programs and determine the best path forward for development, considering all scientific, regulatory, and business constraints.
- Ability to communicate recommendations to internal and external stakeholders and represent CMC in company-wide program teams
- Working knowledge of ICH, FDA, and other applicable regulations/guidelines
- Demonstrated proficiency with word processing, spreadsheet, database, presentation software
SPECIAL WORKING CONDITIONS
- Travel expected 20% of the time.