Flatley Discovery Lab is seeking a Director/Senior Director to join the CMC group and support all programs within our development portfolio. The candidate will be responsible for the development of robust, safe, and cost-effective chemical processes for the scale-up and manufacture of active pharmaceutical ingredients (APIs). The candidate is responsible for the design of experiments, data analysis, and technical transfers among CROs and CMOs. The candidate will serve as the process chemistry, drug substance representative for cross-functional technical development teams which will include representatives from discovery chemistry, manufacturing, formulation development, regulatory CMC, project management, and quality assurance. The candidate must have extensive experience in the strategic and tactical management of CROs and CMOs in cGMP environment. Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent leadership, communication and collaboration skills in a cross-functional, multi-faceted environment; as well as a proven ability to achieve results in a virtual setting with external laboratories and manufacturing facilities are a must. The successful candidate will work directly with clients to ensure deliverables fall within the applicable scope and budget. He or she will coordinate with other departments to ensure all aspects of each project are compatible and will hire new talent as needed to fulfill client needs.
- Develop and implement comprehensive strategies to manufacture drug substance
- Responsible for all aspects of drug substance process research, manufacture and analytical development
- Assume accountability for CRO/CMO strategy including, selection and contract negotiation, project design, ongoing troubleshooting, data analysis and interpretation, QC/audit and oversight of study report writing.
- Identify and manage cGMP drug substance and drug product manufacture of solid oral dosing forms.
- Overseeing budget and goals to ensure a reliable clinical supply chain with well-managed risk
- Provide expert scientific leadership in the areas of non-clinical CMC to both preclinical and development project teams,
- Engage in discovery chemistry activities to help transition optimized leads into preclinical development and help with SAR analogs when needed.
- Strong knowledge of GMP regulations as well as familiarity with regulatory requirements surrounding import and distributions.
- Ensure submissions meet current regulatory standards. Author, review and approve CMC portions of study reports, manufacturing process documentation and regulatory filings (e.g. IND/CTA, IMPD, Investigator’s Brochure, etc.)
- Work with internal and external audiences to meet agreed upon milestones within established time and budget targets.
- Identifies, manages and contributes to external drug substance and analytical testing collaborations.
- Manages CROs on solid state and pre-formulation development.
- Reviews and approves drug substance batch records.
- Interacts closely with internal R&D groups (safety, toxicology, clinical) and partners in conducting efficacy and stability studies.
- Contributes to scientific and strategy discussions to advance and enhance product candidates.
- Contributes to relevant sections of domestic and international regulatory filings.
- Manages clinical drug substance inventory and distribution to domestic and international sites.
- Strong foundation in chemistry, materials science, pharmaceutical sciences or chemical engineering, advanced degree in Organic Chemistry, Ph.D. preferred
- 10+ years relevant pharmaceutical process chemistry and GMP development and experience in the pharmaceutical industry, drug product development experience is preferred
- Strategic view and leadership abilities as well as hands on problem solving skills and strong critical thinking
- Proven experience as a direct manager of people and/or manager of external teams. Experienced project leader with demonstrated ability to lead a team to agree upon milestones within established time end budget parameters
- Strong knowledge of modern synthetic organic chemistry and drug development processes
- The ability to perform under pressure, manage outsourced projects with external vendors, and work effectively in a fast pace environment
- Track record of advancing novel therapeutic agents from discovery into preclinical and subsequent clinical development as Project or CMC leader
- Awareness and understanding of adjacent areas including preclinical and clinical spaces
- Experience with safety, analytical, and stability regulation and protocols.
- Thorough understanding of cGMPs as well as FDA, EMA, USP/PhEur and ICH guidelines
- Experience with process engineering and cGMP.
- Demonstrated ability and willingness to make mission critical decisions on an independent basis
- Demonstrable success in key areas of responsibility
- Ability to work in a team environment and respond to multiple client audiences in the preclinical, clinical and regulatory spaces.
- Outstanding written and verbal communication skills demonstrating the ability to clearly articulate CMC strategies to a diverse audience