About Acadia Pharmaceuticals
Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference.
Please note that this position is based in Princeton, NJ or San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.
Position Summary:
The Senior Director, Chemical Development will lead and advance end‑to‑end drug substance development from early programs through commercial manufacturing. This role owns API process strategy, development, scale‑up, and supply, while leading high‑performing teams and overseeing external manufacturing partners. The Senior Director will define long‑term drug substance strategy, support CMC development and commercial manufacturing, and author key regulatory submissions to ensure a reliable, compliant global supply.
Primary Responsibilities:
- Engage in all facets of development from small scale synthesis to the development of the commercial synthetic route.
- Develop and implement strategic and operational plans to deliver drug substance for multiple development projects to challenging timelines.
- Initiates, evaluates and validates new drug substance CSPs to support commercialization scale up.
- Establish and maintain good working relationships with contract service providers.
- Negotiate and manage contracts and agreements.
- Work with CSPs to diagnose and correct process issues.
- Work with Quality and Regulatory Groups to determine the impact of process deviations and work towards resolutions.
- Develop timelines, goals, and deliverables for drug substances and related manufacturing processes.
- Optimize the manufacturing process to maintain high product quality, improve process portability, assess process scale-ability, increase process robustness, improve process efficiency, and reduce manufacturing costs.
- Ensure supply of drug substance is consistent with development plans by coordinating drug substance production in multiple CSP sites, managing contracts and invoices.
- Ensure CSPs remain current and compliant with all cGMP related requirements, guidelines and procedures.
- Track deviations and processes changes for the different suppliers and collaborate with Regulatory Affairs and Quality Assurance in assessing their impact on regulatory filings.
- Initiate and coordinate the preparation of CMC documentation for regulatory filings.
- Develop CMC plans for assigned projects, with special focus on API sourcing, drug product development and manufacture. Facilitate cross-functional planning of CMC activities across departments and disciplines to align dependencies, schedules, and funding.
- Collaborates with Regulatory Affairs and other groups to support product filings.
- Assist in contract site preparation activities for pre-approval inspections.
- Support interdisciplinary working teams with recommendations, advice and action plans for drug substance-related issues.
- Evaluate new process technology ensuring freedom to operate and expanding the IP for the company.
- Provide onsite process coverage during process registration and process validation as needed to support manufacturing activities and resolve process issues, if any.
- Communicate drug substance related issues and information to committees, teams and interested groups within the company.
- Supervise, train and mentor personnel within the department and at the CSPs, as needed.
- Evaluate business development opportunities from a CMC perspective by providing technical support to due diligence activities.
Education/Experience/Skills:
- PhD in Organic Chemistry required.
- A minimum of 14 years’ experience with progressively responsible positions within the pharmaceutical/biotechnology industry including a minimum of 8 years in a leadership role.
- A combination of relevant education and applicable job experience may be considered.
Must possess:
- Ability to lead in a strategic manner while being able to reduce concepts to practice.
- Strong understanding is required of the drug substance development process including regulatory quality inspections and audits.
- Contemporary awareness of scientific developments and opportunities in chemistry/chemical engineering.
- Is a highly credible technical functional expert with a strong understanding of organic synthetic chemistry concepts.
- Chemistry Manufacturing Controls (CMC) expertise is required to prepare documents for regulatory filing.
- Experience in establishing, managing and leading the CMC teams for pre-clinical through commercial development projects.
- Extensive knowledge of current Good Manufacturing Practices (cGMPs) and experience in chemical development for new drugs.
- Collaborative leader able to operate effectively and with a strong sense of urgency in a fast-paced environment.
- Hands-on approach with a strategic and operational focus; capable decision maker in the execution of responsibilities with a high degree of flexibility to adapt to company and industry changes.
- Outstanding communicator: direct, effective, clear, concise, well organized and appropriate.
- Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the organization.
- Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals.
- Domestic and Overseas Travel is required.
Physical Requirements:
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds weight. Ability to travel by car or airplane independently up to 20% of the time and work after hours if required by travel schedule or business issues.
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What we offer US-based Employees:
- Competitive base, bonus, new hire and ongoing equity packages
- Medical, dental, and vision insurance
- Employer-paid life, disability, business travel and EAP coverage
- 401(k) Plan with a fully vested company match 1:1 up to 5%
- Employee Stock Purchase Plan with a 2-year purchase price lock-in
- 15+ vacation days
- 13 -15 paid holidays, including office closure between December 24th and January 1st
- 10 days of paid sick time
- Paid parental leave benefit
- Tuition assistance
EEO Statement (US-based Employees): Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We strongly encourage you to apply, especially if the reason you are the best candidate isn’t exactly what we describe here.
It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.
As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at [email protected] or 858-261-2923.
Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodations given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.
California Applicants: Please see Additional Information for California Residents within our Privacy Policy.
Canadian Applicants: Please see Additional Information for Canadian Residents within our Privacy Policy.
Applicants in the European Economic Area, Switzerland, the United Kingdom, and Serbia: Please see Additional Information for Individuals in the European Economic Area, Switzerland, the United Kingdom, and Serbia within our Privacy Policy.
Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (“Acadia”). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in the absence of an executed search agreement will not obligate Acadia in any way with respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.
