The Director position requires an expert level understanding of chemical synthesis and process development to oversee the development of Active Pharmaceutical Ingredients (APIs) in both internal and contract development locations. The position is responsible to ensure that all CDMO’s and partners are operating under cGMPs in a safe and reliable manner. The position is responsible to set target synthetic strategy to be aligned with generic commercial targets.
- Manages through others and is fully accountable for all aspects of chemical development to support the generic portfolio projects. This includes inputs to the portfolio selection process, project strategy development, development site selection and stage decisions.
- Directs internal and external teams to develop an optimized synthetic strategy to align with business targets (budgets and timelines).
- Ensures that development projects are on target for timeline and budget by collaborating with project management and development teams internal and 3rd party.
- Closely collaborates with analytical team to ensure an integrated development strategy for generic API products.
- Reviews and provides input on proposals, standard operating procedures and other technical documentation
- Mentors, and provides inputs to the team in areas of technical, regulatory, quality, project management, client interaction, and safety topics a related to chemical development.
- Provides inputs and course corrections to performance of the Chemical Development team (both internal and contractor) through coaching and feedback.
- Drives continuous improvement throughout team to enable improved process understanding and tech transfer to ensure right first time scale up of processes.
- Exhibits a high level of safety awareness and ensures lab operations are conducted in a safe manner.
- Recommends potential courses of action to senior management for enhancing capabilities and workflows by monitoring and analyzing trends across industry as well as within the team and developing well thought out plans.
- Collaborates with the heads of the other functions to resolve problems and drive right first time performance for the team
- Represents the Generic Health group in internal and external technical meetings and presentations
- Able to clearly communicate verbally and in writing to and management.
- Reviews and provides input on proposals received from contractors, standard operating procedures and other technical documentation.
- Other duties as assigned.
Are you the ideal candidate?
- PhD in Organic Chemistry or equivalent with >10 years of process development related experience in a pharmaceutical industry. Experience in generic industry is a plus.
- MS in Organic Chemistry or equivalent with >14 years of process development related experience in a pharmaceutical industry.
- BS in Organic Chemistry or equivalent with >18 years of process development related experience in a pharmaceutical industry.
- Experienced in developing and optimizing synthetic routes and producing and/or scaling up intermediates and cost effective API processes.
- Effectively interfaces with internal and external scientific teams, and all levels of management, with a strong ability to lead through influence.
- Demonstrates strong analytical, written and verbal communication skills. Possesses the ability to write clear and concise technical reports, presentations, and business correspondence.
- Ability to develop a process plan aligned with business objectives, and then plan, organize, and oversee multiple independent development teams to execute according to this team.
- Experience with Design of Experiments (DoE)
- Understanding of process safety concepts and how to incorporate them into process development plans to ensure processes are safe upon scale up.
- Ability to read, analyze, and interpret English-language chemical periodicals, scientific journals, and regulatory documents.
- Extensive knowledge of Microsoft Office.
- Ability to define problems, collect relevant data, recognize patterns, and draw conclusions from disparate information streams. Makes well informed decisions in a timely manner.
- Knowledge of analytical techniques (HPLC, GC, NMR, XRPD, DSC, KF, UV, LC-MS, PH meter).
- Knowledge of MS Project. Experience in establishing integrated plans within resource and task constraints.
- Experience reading and interpreting intellectual property.
- Experience with drafting CMC sections for DMFs for other regulatory filings
- Experience with DynoChem or other modeling software
- Experience working in a GMP production environment