FierceBiotech and FiercePharma Jobs
Senior Director, CMC Development - Advantage ONE Executive Search
Aug 08
Location: Fair Lawn, NJCategories: Director
Position Description
The Director of CMC Development will lead and manage a team that develops chemical processes for manufacture of API. Excellent opportunity to join a young and dynamic biopharma division of an international conglomerate with strong chemical competencies. Company has been developing pharmaceutical capabilities for 15 years and has discovered 3 new compounds now in clinical research and has out-licensed two compounds to big pharma. They are the perfect size, small enough to offer excellent VISIBILITY and a real opportunity to IMPACT the success of the company, but large enough to provide all the resources needed and above average security (not VC funded). Great opportunity to apply your knowledge and experience to design, establish and build a Regulatory Affairs function. If you are weary of all the bureaucracy in big pharma this could be the perfect opportunity for you.
Responsibilities: The successful candidate will lead a group of scientists developing chemical processes for API manufacture through design of new syntheses and process optimization. This key individual will lead chemical development work on several projects and represent chemical development on cross-functional teams, both within the company and with alliance and vendor partners.
Requirements: With a minimum educational degree of Ph.D. or MS. Demonstrated leadership record of projects in API process research and development In-depth knowledge of process chemistry and green chemistry concepts for development of safe and efficient processes Ability to commit to and manage aggressive timelines and deliver on time A thorough understanding of ICH Q7A and cGMPs Actively shares knowledge across different departments and disciplines Assist in development and communication of department goals and strategy Assist in writing chemical process descriptions for CMC sections of regulatory documents A strong publication and/or patent record Excellent written and verbal communication skills Work with the project teams to identify project requirements, optimize project timelines, and develop technical solutions to ensure that API processes are successfully demonstrated and transferred Oversee preparation and review of development history and regulatory documents Ensure that all development and manufacturing activities are carried out in a manner consistent with regulatory requirements. Integrate the principles of Quality by Design and Quality Risk Management into drug substance process development activities Regularly review technical progress on projects to ensure that experiments are scientifically sound and that scientists are aware of current developments in the literature.
Desired: Specify Concentration(s) and/or Major(s): Organic, Synthetic, or Medicinal Chemistry
