POSITION SUMMARY:
This position is responsible for directing all aspects of CMC (Chemistry, Manufacturing and Controls) for pharmaceutical drugs and agents as well as the analytical work associated with that CMC across all of the small molecule projects within Pharma Cinq and, potentially, gene therapy projects. The responsibilities span the range of CMC from sourcing starting materials to formulation development, planning and managing manufacturing of API (active pharmaceutical ingredient) and potential drug products, as well as directing the associated analytical work. This position will also be responsible for the CMC sections of relevant regulatory (FDA and other) documents from INDs to NDAs. This position will work closely with senior management and will supervise the work of others directly and/or across interdisciplinary teams.
DUTIES AND RESPONSIBILITIES:
- Identifies and works with the most suitable manufacturers of APIs.
- Oversees and directs the transfer of manufacturing processes and analytical methods from any current or past vendors to the most suitable CDMOs for each drug candidate.
- Identifies and works with the most suitable chemistry process development-improvement and scale-up laboratories.
- Identifies and works with the most suitable formulation development labs.
- Works within and/or leads project teams to accomplish project goals and manages/coordinates work of other team members.
- Ensures that manufacturing processes, analytical methods and new formulations are and will meet FDA (and other) regulatory requirements, including GLP and GMP.
- Acts as the primary interface with Quality Assurance on matters related to CMC and methods development and validation.
- Manages and works with subject matter experts and consultants as needed.
- Troubleshoots and optimizes manufacturing processes and analytical methods.
- Writes CMC sections of INDs, NDAs, Prior Approval Supplements (PAS), Annual Reports and other FDA (and other regulatory authorities) documents and submissions.
- Reviews CMC data and reports as well as other sections of INDs, NDAs, PAS, Annual Reports intended for submission to FDA and other regulatory agencies.
- Prepares and/or supports preparation of invention disclosures and patent applications.
- Presents progress, challenges, milestones, needs to senior management and makes recommendations.
- Works cross functionally with other business units on projects/products or associated deliverables.
- Specific duties may vary depending upon prioritization of projects and programs.
EXPERIENCE AND QUALIFICATIONS:
- Ph.D. in Organic Chemistry, Chemical Engineering or related field.
- Bachelor's degree in chemistry prior to Ph.D. preferred.
- A minimum of 12 years directly relevant industrial experience.
- A minimum of 5 years direct experience managing external CDMOs (contract drug manufacturing organizations) and participating in project teams composed of internal and external (CDMO, consultants) team members.
- Direct experience with and knowledge of the requirements for tech transfer of drug substance and drug product manufacturing processes and analytical method development and validation.
- Direct, hands-on experience with writing and reviewing CMC sections of INDs, NDAs and related regulatory documents.
- Direct experience in managing and directing formulation development.
- Direct experience in selecting and working with stage-appropriate CDMOs.
- Direct experience in selecting and working with process improvement and scale-up labs.
KNOWLEDGE, SKILLS AND ABILITIES:
- Thorough understanding of FDA requirements and guidelines for GMP manufacturing and analytical methods for clinical and commercial pharmaceuticals.
- Knowledge of viral vectors and gene therapy development and manufacturing is a plus.
- Problem solving skills and demonstrated ability to organize and move project tasks forward in an orderly and structured fashion.
- Strong analytical skills with the demonstrated ability to gather and evaluate complex data and information and develop a recommendation and plan of action.
- Excellent organizational, planning, and time management skills with the ability to manage multiple and often changing priorities and issues of varying complexity, while meeting time-sensitive deadlines and deliverables.
- Solid leadership skills with demonstrated knowledge and understanding of staff management practices and processes. Ability to establish accountabilities and expectations and manage performance to achieve results.
- Demonstrated propensity to be collaborative, proactive, and self-motivated in the prioritization, execution and completion of projects.
- Strong communication (written and verbal) skills regardless of the format (e.g., documents, public speaking situations, presentations, etc.).
- Attention to detail with demonstrated commitment to excellence and performance.
- Proven proficiency in Microsoft Office (i.e., Word, Excel, PowerPoint, Outlook).
- Expertise with data analysis programs, such as JMP and GraphPad Prism.
PHYSICAL DEMANDS:
- While performing the duties of this job, the individual is frequently required to sit for long periods, use a computer and participate in telephone (or WebEx, etc.) calls. The individual is occasionally required to travel to contract manufacturers or laboratories.
WORK ENVIRONMENT:
- Office environment.
- Occasional travel to contract manufacturing or laboratory sites.
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