Exec Director, API Synthetic Development
About The Position
Directs the route selection, design, and scale-up of pharmaceutical ingredient (API) processes – inclusive of instruments and equipment - from the laboratory through pilot and manufacturing scale. Manages the science and engineering underlying the development and implementation of processing technologies and products to achieve cost effectiveness and improved product quality. Independently conducts synthesis and process development activities for preclinical and clinical candidates, including laboratory experimentation for compound preparation. Plans and implements the development of new process formulas, establishes operating equipment specifications and may advise manufacturing techniques and process equipment changes. Acts as liaison with Research and/or Commercial to ensure processes and designs are appropriate for the customer. Selects, develops, and evaluates personnel to ensure the efficient operation of the department. Works on challenges of significant scope in which analysis of situation or data requires executive review and discussion.
Requirements
- BS/BA degree in Chemistry or similar discipline and 16+ years of experience in pharmaceutical/ process development field and extensive previous leadership experiences also required OR Master's degree in Chemistry or similar discipline and 14+ years of similar experience noted above OR PhD in Chemistry or similar discipline AND 12+ years of similar experience noted above
- A thorough understanding of organic chemistry and process chemistry as well as current literature is required
- Manufacturing expertise in Chemical Development
- Good understanding of cGMP requirements in API manufacturing as demonstrated through past and present training and responsibilities
- Must have a demonstrated track record of managing multiple programs, resources and staff
- Must have extensive expertise in working with CRO/CMO's both as a lead and a team member
- Acts as a "trusted advisor" across the company and may be recognized as an external expert
- Provides strategy, vision and direction regarding issues that may have company-wide impact
- Requires in-depth knowledge of the functional area, business strategies, and the company’s goals
- Possesses industry-leading knowledge
- Must be self-motivated, detail-oriented, decisive
- Ability to quickly learn and think independently
- Excellent interpersonal & communication skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside the Company
- Excellent managerial skills and experience fostering career development of direct and indirect reports
- Demonstrated ability to influence and lead others
Responsibilities
- Drives strategic vision and direction for API Development
- Directs the design and scale-up of processes, instruments and equipment from the laboratory through pilot plant and manufacturing scale-up
- Manages the science and engineering underlying the development, implementation, and maintenance of process methods and equipment for the production of process formulas, technologies and products to achieve cost effectiveness and improved product quality
- Plans and implements the development of new process formulas, establishes operating equipment specifications and improves manufacturing techniques and new process equipment production
- Acts as liaison with research and/or development to ensure processes and designs are compatible.
- Selects, develops and evaluates personnel to ensure the efficient operation of the function
- Supports off-site synthesis and interaction with scale-up/ manufacturing contractors
- Effectively documents research and conducts work in a safe manner in accordance with company and departmental guidelines
- Performs other duties as assigned
- Interacts internally and externally with executive level management, requiring negotiation of extremely critical matters.
- Influences policy-making
- Leads multiple disparate groups and actively contributes to strategic planning for the larger function
- Partners with executive leadership team for the function to provide cohesive direction towards company goals
- Regularly interacts with vendors, regulatory bodies and other external stakeholders exerting influence and negotiating to drive business results
- Directs and controls the activities of multiple functional areas, divisions, product groups or service area
- Other duties as assigned
Benefits
- retirement savings plan (with company match)
- paid vacation, holiday and personal days
- paid caregiver/parental and medical leave
- health benefits to include medical, prescription drug, dental and vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Executive
Education Level
Ph.D. or professional degree
