Title: Head of Chemistry, Manufacturing and Controls (CMC)
Location: Waltham, MA
Entasis is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel antibacterial products to treat serious infections caused by multidrug-resistant Gram-negative bacteria. Entasis’ targeted-design platform has produced a pipeline of product candidates, including ETX2514SUL (targeting A. baumannii infections) being initiated for Phase 3 clinical trials, zoliflodacin (targeting Neisseria gonorrhoeae) being initiated for Phase 3 clinical trials, and ETX0282CPDP (targeting Enterobacteriaceae infections). Entasis is also using its platform to develop a novel class of antibiotics, non-β-lactam inhibitors of the penicillin-binding proteins (NBPs) (targeting Gram-negative infections).
Entasis Therapeutics is seeking an experienced and effective leader to play a very significant role in driving innovative products from early and late-stage discovery through product approval. This individual will be accountable for chemical development, formulation development, process development, analytical science, and supply chain. The Head of CMC will report to the Chief Development Officer and play a pivotal role in shaping the direction and priorities of the R&D organization and help translate these priorities to actions that enable Entasis to deliver on key objectives across the portfolio.
- Design and champion CMC roadmap for company
- Establishing a drug substance and drug product strategy and, in partnership with business development, negotiate contracts with CROs/CMOs
- Hire, retain, lead all talent in CMC function
- Designing and overseeing relevant studies across the portfolio with regards to pharmaceutical development sciences
- Oversight/review (and author, as appropriate) all relevant CMC sections for regulatory submissions to support our product candidates
- Reviewing study reports, manufacturing process documentation, investigator brochures, clinical study protocols, and clinical trial documentation for compliance with appropriate regulations and guidelines for CMC related issues.
- Identify execution risks and develops contingency plans as needed
- Partner with executive team in reaching timely, data-driven decisions with regard to CMC and drug manufacture.
- Establish CMC operations for chemical development, formulation development, process development, analytical science, and supply chain
- Ensure robust planning and execution of product development efforts across the organization’s portfolio of development stage product candidates
- Help create, and deliver to, the overall R&D strategy and key priorities
- Encourage innovative, cross-functional thinking, and engagement of outside expertise as appropriate to further help advance R&D goals
- Maintain a robust longer-range CMC plan to support the broader organizational objectives and prepare the company for a potential product launch.
- Ensure effective communication and alignment of efforts both within clinical operations and key partners internal and external (particularly regulatory and quality assurance).
- Act as liaison and/or provide support to team members to act as liaison with FDA and other regulatory agencies for CMC issues
- Work closely with organization partners as well as internal colleagues to ensure effective working relationships and to proactively identify and mitigate risks to the conduct of work to advance our products in a timely manner
- Develop and track CMC budget with finance. Secures approval of changes arising throughout the year due to changing conditions/plans
- Perform on-site visits with key manufacturing providers as needed.
- PhD in pharmaceutical sciences, chemistry or engineering with significant experience in industry is essential
- Demonstrated ability to be effective in an entrepreneurial, fast-paced environment
- Comprehensive understanding of all aspects of CMC including chemical development, formulation development, process development, analytical science, supply chain, regulatory, and quality for small molecule products
- Experience with injectable products is required. Experienced with oral products is highly preferred.
- Experience with regulatory submissions, interactions with regulatory agencies regarding CMC issues at all stages of product development
- A proven track record of successfully progressing drug candidates from IND through NDA submission
- Excellent analytical, communication, presentation, writing, and leadership skills
- Experience in writing CMC regulatory documents highly preferred
- Biotech, outsourcing experience desirable