Sr. Manager, Chemical Development

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 can be based in Princeton, NJ OR San Diego, CA. Acadia's hybrid model requires this role to work in our office an average of 3 days per week. Position Summary: Responsible for the chemical process development, implementation and management of robust, cost effective, and safe processes for the manufacture of APIs from the research stage, through clinical development and marketing approval. Will be responsible for the technical development, support, innovative solutions and commercialization of drug substances using an external network of providers. This position is integral to the advancement of ACADIA’s growing portfolio of drug candidates, and will provide technical oversight, expertise and guidance of externalized drug substance development related activities. Primary Responsibilities: Lead scientific strategy for drug substance development, ensuring scalable, efficient, and compliant processes that meet clinical and commercial needs Oversee contract service providers (CSPs) to develop, optimize, and scale manufacturing processes from preclinical through commercialization Apply risk assessments and Quality by Design (QbD) principles to define design space and establish robust control strategies Develop end-to-end drug substance strategies supporting product quality, global regulatory approvals, and supply chain flexibility Manage technology transfer, outsourcing, and external manufacturing to build a reliable and scalable supply chain Establish, evaluate, and manage CSP partnerships, including contract negotiation, performance oversight, and issue resolution Ensure cGMP compliance, oversee deviations and change management, and partner with Quality and Regulatory to assess impact on filings Lead planning and execution of timelines, deliverables, and CMC documentation to support regulatory submissions and inspections Provide cross-functional leadership and technical expertise, supporting internal teams, governance forums, and external diligence activities Education/Experience/Skills: Ph.D. degree in Synthetic Organic Chemistry or other related scientific discipline. A minimum of 8 years of relevant progressive experience in API development and manufacturing in the pharmaceutical/biotechnology industry with a minimum of 5 years in a scientific role. An equivalent combination of relevant education and applicable job experience may be considered. Requirements: Leadership experience in managing diverse project activities with contract CDMO facilities at different global locations Experience with global pharmaceutical/chemical development and manufacturing operations for development-stage small molecules, including upstream/downstream process development. Well-versed in drug substance manufacturing control strategies Highly knowledgeable with FDA and ICH guidelines relating to registration, quality and compliance with small molecule drug substance Awareness of scientific developments and opportunities in chemistry/chemical engineering Strong understanding of organic synthetic chemistry concepts and cross-functional understanding related to API development from pre-IND through NDA Chemistry Manufacturing Controls (CMC) expertise to prepare documents for regulatory filing (e.g. IND to NDA) Extensive knowledge of current Good Manufacturing Practices (cGMPs) and experience in chemical development for new drugs Excellent communication, interpersonal and presentation skills. Ability to effectively collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators) Skilled at negotiating with business partners/management and influencing senior level leaders regarding matters of significance to the organization. Demonstrated problem-solving abilities and conflict resolution skills Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals Physical Requirements This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs. In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location. Salary Range $154,200 — $192,700 USD 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 with in 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.