New

Associate Director Chemical Development

Acadia Pharmaceuticals Inc.
United States, New Jersey, Princeton
Feb 21, 2025
About Acadia Pharmaceuticals Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding, we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson's disease psychosis and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer's disease psychosis, and multiple other programs targeting neuro-psychiatric and neuro-rare diseases. For more information, visit us at Acadia.com and follow us on LinkedIn and X. Please note that this position is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average. Associate Director, Chemical Development will be 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. This position will manage the technical development, support, provide 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. The scope of the role encompasses a wide breadth of life-cycle, ranging from early stage development, late stage development, process validation, contribution towards CMC content for regulatory submissions, regulatory approval and product life cycle management. The role will be critical in ensuring optimized development, reduced risk profiles and ultimately accelerate the development cycle of assets. Primary Responsibilities Provide strong scientific support to the overall chemical development team to ensure that the development plan provides for rapid and innovative process development and scale-up of drug substance incorporating quality, safety, compliance, cost-effectiveness, sustainability and reliability to meet development and commercial requirements Oversee contract development organizations to lead the development and optimization of drug substance processes to support the program from pre-clinical phase through marketing approval Perform risk assessments of manufacturing process scale-up and use Quality by Design (QbD) principles to define the design space and develop an overall control strategy Formulate drug substance development strategy to ensure product quality, facilitate regulatory approvals globally and achieve operational flexibility of supply chain Facilitate technology transfer, chemical outsourcing, external manufacturing to deliver a robust supply chain for all drug substances Foster an inclusive workplace, creating staff development opportunities, encouraging innovation, advocating a quality culture, maintaining safety and achieving high performance 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 Initiate, evaluate and validate new drug substance CSPs (Contract Service Providers) to support commercialization scale-up Establish and maintain good working relationships with contract service providers, including negotiate and manage contracts and agreements Work with CSPs to diagnose and correct process issues Work with Quality function to determine the impact of process deviations and works toward 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, increase process robustness, improve process efficiency, and reduce manufacturing costs Ensure the 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 Collaborate 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 validation or as needed to resolve process issues Communicate drug substance related issues and information to committees, teams and interested groups within the company Support corporate development activities, serving as drug substance/chemistry expert, as part of cross-functional diligence teams to assess external assets/opportunities Education and Experience PhD in synthetic organic chemistry or a related field. Targeting 8 years of experience in pharmaceutical research, development and manufacturing with 2 years' experience in a leadership role preferably in the areas of process development, process characterization, process validation, drug substance manufacturing and/or product life cycle management. An equivalent combination of relevant education and experience may be considered. 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 and manufacturing 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 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. #LI-HYRBID #LI-BG1 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 single 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 would strongly encourage you to apply - especially if the reason you are the best candidate isn't exactly as we describe it 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 [emailprotected] or 858-261-2923. Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment. Notice for California Applicants: Please see our California Applicant Privacy Notice 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 absence of an executed search agreement will not obligate Acadia in any way with the 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.