Senior Manager, API Process Development
Responsible for the development of manufacturing processes for pharmaceutical Drug Substance, technology transfer and phase 3 clinical productions at contract manufacturing organizations. This includes planning and managing the implementation of drug substance processes for registration, validation and commercial launch. Provide technical guidance and support for drug substance at either the commercial or R&D stages. Recommends process improvement projects to internal and/or external partners and collaborates to ensure implementation.
- Development of chemical processes for clinical and commercial manufacturing of drug substances.
- Design of synthesis, identification of key process parameters and relevant in-process controls, understanding origins of process impurities and their controls, mechanistic studies of reactions, when needed, and isolation of products.
- Ensure successful technology transfer to contract organizations and support of ongoing manufacturing.
- May lead a team of scientists within Cubist as well as at a CMO as appropriate within the API project's scope.
- Represent the chemical technology group at CMC meetings to provide assessments, evaluations, status, issues and other relevant technical aspects of the corresponding program.
- Supporting regulatory submissions by either proivinid advice, necessary data or writing and/or reviewing specific sections
- Providing subject matter expertise to attorneys to support patent applications.
Minimum Basic Qualifications
- MS and/or PhD in organic chemistry
- 9 years with MS and 6-7 years with PhD in pharmaceutical process development and Drug Substance manufacturing at a commercial level required
- Proven track record in developing and implementing robust and efficient drug substance manufacturing processes
- Experience in the technology transfer and technical support (including troubleshooting) of drug substance manufacturing processes
- Extensive experience in collaborating with sites and third party manufacturers
- Experience in troubleshooting and general support (documentation reviews, deviation investigations, etc.)
- Experience in validation of manufacturing drug substance processes
Desired Competencies and Qualifications:
- Proven track record in cGMP manufacturing
- Exposure to regulatory agencies inspections
- FDA interactions (e.g. correspondence, face to face meetings)
- Proven track record in leading teams with cross-functional scope
- Excellent communication and collaboration skills, ensures alignment with other functions
- Exceptional problem solving skills, fosters excellence throughout the organization
- Broad understanding of regulatory and quality requirements for pharmaceutical products
- Demonstrated ability to see beyond own function to understand business issues and implement best practices
- Ability to leverage an in-depth understanding of the organization to build up credibility and acceptance of projects
- Demonstrated ability to lead and develop teams and individuals
- Experience in overseeing contract manufacturing organizations
- Experience reviewing and/or authoring CMC section for regulatory submissions
- Experience on implementation PAT applications on DS manufacturing (e.g. KF, pH, etc.)
- Knowledge of cleaning validation regulations
- Office in Lexington, MA
- Up to 30% travel
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position's essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Cubist is an Equal Opportunity Employer (EOE). M/F/D/V