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
Ensure cGMP compliance, oversee deviations and change management, and partner with Quality and Regulatory to assess impact on filings
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.
What we offer US-based Employees:
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 talentacquisition@acadia-pharm.com 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.
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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.