Director, Drug Substance Development
Roivant is seeking a highly skilled and experienced Director of small molecule Drug Substance Development. S/He will play a pivotal role in ensuring quality, integrity, and regulatory compliance during drug substance development.
This role is responsible for directing technical aspects of drug substance route scouting, process development and manufacturing activities at Roivant’s contract development and manufacturing vendors including preclinical drug substance development, process transfer, scale-up, registration batch manufacture, validation, launch, on-going manufacturing support and process improvements.
Additional responsibilities include due diligence to support in-licensing, vendor selection and vendor management.
The role reports to the Vice President & Head of CMC, Small Molecule Development and involves close collaboration with cross-functional teams, including formulation development, analytical development, project management, regulatory affairs, quality, and external partners.
- Provides direction for all aspects (route scouting, technology transfer, manufacturing, stability, scale-up, validation, launch and on-going commercial support) of development, manufacture and testing of drug substance at global vendors.
- Contribute knowledge and strategy for all aspects of drug substance development including synthesis development, technology transfer, manufacturing, and testing.
- Designs process optimization activities to ensure API processes are robust, cost-effective and fit for purpose.
- Directs Quality by Design (QBD) experiments for drug substance development.
- Ensure adherence to project timelines and budgets.
- Interfaces with and provides onsite direction and management of the company’s vendors to ensure bulk drug substance operations are maintained in compliance with stage appropriate cGMP requirements at all times.
- Reviews and provides oversight of all documentation related to the production of drug substances including, but not limited to development, scale-up and validation protocols/reports batch records, deviations, process excursions, SOP’s, etc. in conjunction with the vendor and other groups adjudicate deviations, excursions, etc.
- Ability to lead or conduct investigations, root cause analysis and implement proposed corrective actions at CRO/CMO.
- Provide appropriate drug substance expertise to support Business Development group for the scientific evaluation of drug candidates during in-licensing opportunities.
Skills, Qualifications, and Requirements
- MS/PhD in Organic Chemistry, Chemical Engineering, Pharmaceutical Sciences or related field with 10+ years of experience in the pharmaceutical industry working in development/pilot plant/commercial manufacturing operations for pharmaceutical APIs (drug substances).
- Superior communication skills (both written and oral) are essential.
- Experience working in a multi-cultural environment is necessary with a demonstrated ability to contribute successfully in a multi-disciplinary team environment.
- Must have demonstrated experience in managing and influencing diverse project activities with third party manufacturing facilities at different geographical locations.
- Strong project management experience with cross-functional team leadership and participation skills.
- Demonstrated scientific knowledge and abilities relevant to development and manufacture of APIs (drug substances) as well as the drug development process.
- Requires expert understandings of technology transfer; cGMPs, FDA, EU, ICH guidelines; as well as CMC content of regulatory submissions.
- Strong understanding and working knowledge of cGMPs for pharmaceutical development and commercial operations.
- Demonstrated alignment with Roivant’s values and culture.
- Self-starter who is capable of working independently.
- Task oriented and able to prioritize multiple objectives.
Roivant Sciences provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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