Exec Director, API Synthetic Development

Neurocrine Biosciences; San Diego (CA); On-site; USD 236,800 - 323,000; Full time

Benefits offered by this job

Annual bonus target of 35%

Retirement savings plan with company match

Paid vacation and personal days

Health benefits including medical, dental, and vision

Job summary

Neurocrine Biosciences in San Diego is seeking an experienced leader to direct the design and scale-up of pharmaceutical ingredient processes. The role involves managing process development and ensuring compatibility across research and commercial initiatives.

The ideal candidate will possess a strong background in organic chemistry, extensive leadership experience, and a proven track record in managing multiple programs and resources. This position offers a competitive salary and comprehensive benefits.

Qualifications

• Thorough understanding of organic chemistry and process chemistry required.
• Good understanding of cGMP requirements in API manufacturing.
• Proven track record of managing multiple programs and staff.

Responsibilities

• Drives strategic vision and direction for API Development.
• Directs design and scale-up of processes from lab to manufacturing.
• Acts as liaison with research to ensure process compatibility.

Skills

Organic chemistry

Process chemistry

Leadership

Project management

Communication skills

Education

BS/BA degree in Chemistry or similar discipline and 16+ years of experience

Master’s degree in Chemistry or similar discipline and 14+ years of similar experience

PhD in Chemistry or similar discipline and 12+ years of similar experience

Job description

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.

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

Qualifications

• 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

Benefits

The annual base salary we reasonably expect to pay is $236,800.00-$323,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills.

In addition, this position offers an annual bonus with a target of 35% of the earned base salary and eligibility to participate in our equity based long term incentive program.

Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

EEO Statement

Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.