Role Summary:
The Associate Director Drug Product will be responsible for drug product activities including formulation development and scale-up through registration and validation. This individual will provide technical expertise, and specialized knowledge in formulation development and drug product manufacturing. This role will work closely with drug substance, analytical, clinical supply logistics, and quality assurance. The Associate Director will be accountable for all Drug Product development and manufacturing activities.
Essential Duties and Responsibilities
:
- Provide technical expertise and drive formulation development activities for complex and challenging compounds.
- Responsible for initiating, evaluating, and managing CMOs for formulation development and Drug Product GMP manufacture, as well as providing in person technical support, as needed, to oversee various manufacturing/scale-up/validation activities and provide technical expertise to trouble-shoot manufacturing/packaging process issues.
- Develop long-term plans, including timelines, budget, and API requirements to support drug product development and clinical trial material manufacture through to process validation. Responsibilities will include continuing to build formulation development capabilities.
- Evaluate the activities and emergent data from on-going formulation development, manufacturing and analytical data at CMOs.
- Collaborate with Quality Assurance to ensure the quality of the company’s manufactured products and communicate appropriately to cross-functional teams and senior management.
- Lead, facilitate, and participate in technical discussions as subject matter expert in drug products to successfully resolve problems with suppliers, methods, project issues, deviations and investigations.
- Collaborate with QA, CMC team and CMOs towards timely generation and approval of documents.
- Actively contribute to key CMC sections of regulatory documents eg: INDs/IMPDs/NDAs/MAAs.
- Ability to travel up to onsite company visits and to CMO’s as needed. (Approx 15% of time)
Education and/or Work Experience Requirements:
- BS, MS, or Ph.D. in Chemistry or Chemical Engineering or equivalent with 8+ years related experience within a Pharmaceutical or Biotechnology Company.
- Hands-on experience in formulation development, process optimization, scale-up, technology transfer, and manufacturing of solid oral and parenteral dosage forms of small molecules.
- Deep understanding of the scientific disciplines that underlie the physical and physiological behavior of various small molecule drug formulations, including those for oral and parenteral delivery.
- Must be experienced in managing clinical stage and validation programs as a drug product lead.
- Expert knowledge and experience in using Design of Experiments, and other tools in the Quality by Design paradigm.
- DemonstratedProject Management expertise with the ability to develop and execute long term development plans.
- Experience in the selection, contract negotiation and management of various types of CMOs in support of small-molecule formulation development / DP manufacturing activities.
- Working knowledge of Good Manufacturing Practices (cGMPs) and Regulatory Guidance Documents as they relate to manufacture and quality testing of pharmaceutical products
- Takes initiative, with strong analytical skills and attention to detail and accuracy.
- Demonstrates advanced team facilitation skills that consistently foster effective brainstorming and decision making with both internal colleagues and vendors, particularly in a startup environment.
- Excellent technical writing, oral, presentation, and interpersonal communication skills.
Disclaimer:
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.Fore Bio provides equal employment opportunities (EEO) to all employees and applicant for employment without regard to religion, race, creed, color, sex orientation, national origin, age, marital status or any other characteristic protected by applicable federal, state, or local law.
