Exec Director, API Synthetic Development

Neurocrine Biosciences • San Diego, CA

3d

About The Position

Neurocrine Biosciences is a leading biopharmaceutical company dedicated to discovering, developing, and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine, and immunological disorders. The company's diverse portfolio includes FDA-approved treatments and a robust pipeline. This role directs the route selection, design, and scale-up of pharmaceutical ingredient (API) processes, including instruments and equipment, from laboratory through pilot and manufacturing scale. It involves managing the science and engineering underlying the development and implementation of processing technologies and products to achieve cost effectiveness and improved product quality. The position independently conducts synthesis and process development activities for preclinical and clinical candidates, plans and implements the development of new process formulas, establishes operating equipment specifications, and advises on manufacturing techniques and process equipment changes. The role also acts as a liaison with Research and/or Commercial to ensure processes and designs are appropriate for the customer, and selects, develops, and evaluates personnel to ensure efficient department operation. This position addresses challenges of significant scope requiring 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 OR Master's degree in Chemistry or similar discipline and 14+ years of similar experience OR PhD in Chemistry or similar discipline AND 12+ years of similar experience
• 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
• Demonstrated track record of managing multiple programs, resources and staff
• 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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree