Director, Formulation Development
About The Position
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. Acadia's hybrid model requires this role to work in our office three days per week on average. Position Summary The Director, Formulation Development leads formulation, primary packaging, and manufacturing process development across Acadia’s portfolio of drug candidates from early development through commercialization. This role provides technical leadership for externalized drug product development across oral solid, liquid, and injectable dosage forms, with a primary focus on oral solid dosage forms. The position is responsible for managing Contract Service Providers (CSPs), resolving complex technical issues, and advancing manufacturing process technologies that support clinical supply, process validation, and lifecycle management. This role plays a key part in reducing development risk, improving execution, and accelerating program progression.
Requirements
- Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or a related field required; an equivalent combination of education and relevant industry experience may be considered.
- Minimum of 10 years of progressively responsible experience in formulation and manufacturing process development, including leadership responsibilities.
- Proven success in formulation and dosage form development, with experience authoring technical reports and CMC sections for regulatory submissions.
- Deep understanding of dosage form formulation, primary packaging, manufacturing process development, scale-up, optimization, and validation
- Demonstrated success in oral solid dosage form development of new chemical entities
- Strong knowledge of cGMP requirements and experience supporting regulatory filings, including NDAs or other marketing authorization applications
- Proven ability to manage external development and manufacturing partners, including CROs, CMOs, and CSPs
- Strong written and verbal communication skills, with the ability to translate complex technical information for cross-functional audiences
- Demonstrated leadership, influence, and resource alignment across functions to achieve development and organizational goals
- Flexibility to travel domestically and internationally
Responsibilities
- Design and develop pharmaceutical formulations and manufacturing processes to support clinical development, registration, and product launch
- Evaluate and qualify Contract Service Providers (CSPs) to support development, scale-up, and commercialization, and manage related supplier agreements as needed
- Lead and oversee the development and scale-up of clinical formulations and finished dosage forms at CSPs, serving as on-site technical support when required
- Plan and direct scientific and technical activities, including data interpretation, evaluation of results, development of conclusions, and preparation of technical reports and presentations
- Partner with clinical supply management to define supply requirements and align CSP manufacturing schedules to ensure uninterrupted availability of clinical trial materials
- Conduct risk assessments of manufacturing processes and products at key development milestones and drive resolution of findings with relevant CSPs
- Author and review technical reports and development documentation to support regulatory submissions, including review of MBRs, BPRs, and CSP-generated reports
- Collaborate with analytical, manufacturing, quality, and regulatory teams to develop plans and protocols for drug product development and lifecycle management
- Ensure compliance with cGMP and applicable GxP requirements, and support CSP readiness for health authority and pre-approval inspections
- Perform other responsibilities as assigned
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Director
