This position is responsible for leading the formulation and process development, manufacture, release and stability of portfolio drug candidates with a focus on drug substance and analytical activities, and support of development from pre-formulation through late stage. This position is also responsible for assisting in the technical transfer, process and method development, optimization, qualification, and validation of activities related to all manufacturing operations, and management/oversight of drug candidate supply chain by efficient manufacturing planning, maintenance of inventory and distribution of clinical trial material in support of studies in all territories.
This is an office-based position that works in a cross-functional and dynamic environment. Clear, timely, professional, and effective communication with all HUYABIO functional areas and global office sites is essential.
Primary Duties and Responsibilities
- Lead the process development, manufacture, release, and stability of portfolio drug candidates with a focus on drug substance and analytical activities
- Manage/oversight of drug candidate supply chain by efficient manufacturing planning, maintenance of inventory, and distribution of clinical trial material in support of studies in all territories.
- Lead the technical transfer, process and method development, optimization, qualification, and validation of candidate analytical methods
- Evaluate and manage third-party contract manufacturers, domestic and foreign, and inter-company alliances with drug substance (API) and drug product manufacturers
- Lead CMC project management support and work closely with pharmaceutical development functions of research and development, process development, drug substance manufacturing, clinical operations, regulatory and quality functions
- Identify and resolve technical challenges in the areas of drug substance process development and manufacturing, drug product formulation development, drug product process development, manufacturing, and packaging, and analytical method development/validation.
- Creation and execution of CMC development plans for new products
- Assist in deviation investigations
- Assist in due diligence technical assessments of potential new products
- Review and approve master and executed batch records from all manufacturing activities; analytical release testing, stability studies and investigations, as required
- Maintain knowledge of current best practices of drug delivery and identifies emerging trends and technologies and lead implementation/feasibility assessment, as appropriate
- Develop and support the global regulatory CMC strategy in partnership with other departments to support clinical studies and necessary manufacturing documents in support of IND, NDA, MAA, and other applications.
- Participate in representing the regulatory CMC group at health authority meetings and interactions, including FDA, EMA, and others as required
- Partner with the global Regulatory Affairs and Quality & Compliance teams to provide regulatory CMC support, leadership, and resource to ensure inspection readiness and preparedness
- Author relevant sections of regulatory documents, including Investigator’s Brochure, Pharmacy Manual, Study Protocols, IND filings, IMPD, and DMFs
- Assist in developing and maintaining document control folders for CMC-related documents
- Lead product development project teams as CMC functional area representative
- Track proposals and invoices to insure alignment with the approved CMC budget
- Manage consultants, vendors, and CROs to meet agreed-upon program timelines/budgets
- Other duties as assigned
Job Qualifications and Requirements
- PhD. or equivalent in Chemistry, Pharmaceutical Sciences, or related Life Science discipline, preferred. MS with extensive pharmaceutical industry experience in manufacturing/CMC will be considered.
- 15+ years experience in pharmaceutical development and manufacturing in the biotech/ pharmaceutical industry.
- Experience with the development and validation of analytical methods required.
- Experience in supply chain strategy and management required.
- Extensive experience with the development, optimization, and scale-up of manufacturing processes for small molecules. Formulation development of poorly soluble compounds expertise desired
- Leadership and management experience essential with proven ability to coach and motivate employees, set priorities, and effectively make decisions
- Hands-on experience in oversight and management of CMC activities at CMOs and partner facilities.
- Strong analytical and problem-solving skills, with the ability to ‘troubleshoot’ in all areas of CMC.
- Solid understanding of FDA and EMA regulatory guidance/requirements as well as experience with authoring regulatory submissions. Demonstrated ability to represent the company at regulatory meetings.
- Thorough knowledge of GMP requirements and familiarity with GLP/GCP.
- Experience in the implementation of GMP QMS, quality oversight/release requirements in the US and EU, root cause analysis, and CAPA implementation. Continuous improvement and Six Sigma training and mindset are highly desirable.
- Excellent interpersonal, organizational, negotiation, and communication (verbal and written) skills are essential.
- The ability to think, plan, and influence strategically and diplomatically on the process development priorities across multiple projects is necessary.
- Must be a leader willing to be both a “coach and a player”.
- Willingness to travel domestically and internationally as needed.
- Experience in the development of the plant, semi-synthetic molecules a plus