Director of Chemical Development and Drug Substance Manufacturing
4 weeks ago
We are seeking a highly motivated and experienced individual to lead our Chemical Development team. As a key member of our research and development team, you will be responsible for planning and executing research techniques to solve complex chemical problems in the synthesis, analysis, development, or production of drug substances.
Key Responsibilities:- Plan and execute research techniques to solve complex chemical problems
- Manage development activities for cGMP drug substance manufacturing of small molecule drugs
- Direct experience in working with CROs and CDMOs from USA and Europe is preferred
- Design process development studies according to Quality by Design (QbD) principles
- Identify critical quality attributes for process intermediates and API
- Maintain a current laboratory notebook in accordance with company policy
- Review Master/Executive batch records and provide suggestions in a timely manner
- Route scouting by applying organic chemistry knowledge and principles
- Work closely with chemists to understand and improve chemical processes
- Utilize analytical instrumentation for monitoring laboratory experiments and compound analysis
- Communicate effectively in verbal and written form on research results, issues, and plans
- Master's degree with 10 years or more or Ph.D. with 7 years or more relevant experience in small molecule process chemistry
- In-depth understanding and knowledge of cGMP regulations and compliance
- Experience in drafting drug substance sections of INDs, IMPDs, and marketing applications
- Strong experimental background and analytical approach to problem solving
- Ability to prioritize responsibilities, multi-task, and remain flexible and motivated in a fast-paced environment
- Strategic thinking to address technical challenges and provide creative solutions
- Good communication and interpersonal skills
Biomea Fusion, Inc. is a biotechnology company dedicated to developing innovative solutions for patients. We value diversity and inclusion in our workplace and strive to create a collaborative and dynamic environment.
The expected salary range for this role is $210,000 to $230,000. An individual's position within the range may be influenced by multiple factors, including education, years of relevant industry experience, and market dynamics.
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