Director, Formulation Development

Acadia Pharmaceuticals; Princeton (NJ); Hybrid; USD 170,200 - 212,700; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) Plan with company match

Paid parental leave benefit

Job summary

Acadia Pharmaceuticals in Princeton, NJ is seeking a Director of Formulation Development to lead formulation and manufacturing process development across their portfolio. The ideal candidate will have over 10 years of experience in the industry and a strong focus on oral solid dosage forms.

This hybrid role requires collaboration across various teams to ensure successful development and compliance with regulations. A competitive salary range of $170,200 – $212,700 is offered, along with additional benefits.

Qualifications

• Minimum of 10 years of progressively responsible experience in formulation and manufacturing process development.
• Proven success in formulation and dosage form development.
• Strong knowledge of cGMP requirements.

Responsibilities

• Design and develop pharmaceutical formulations and manufacturing processes.
• Evaluate and qualify Contract Service Providers (CSPs).
• Lead and oversee development and scale-up of clinical formulations.

Skills

Formulation development

Manufacturing process development

Leadership

Communication

Education

Advanced degree in Pharmaceutical Sciences or related field

Job description

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.

Location and Work Model

This position can be based in Princeton, NJ. The 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. The 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. It manages Contract Service Providers, resolves complex technical issues, and advances manufacturing process technologies that support clinical supply, process validation, and lifecycle management, playing a key part in reducing development risk, improving execution, and accelerating program progression.

Primary 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

Education, Experience, & Skills

• Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field required; equivalent combination of education and 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 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

Scope

This role manages complex projects and technical programs to achieve functional objectives in alignment with established policies, timelines, and business goals. The position addresses cross‑functional challenges, develops methods and evaluation criteria for projects and programs, and partners with management on matters affecting the functional area.

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand, walk, sit, use hands to handle or feel objects, reach with hands and arms, climb or balance, stoop, kneel, crouch, and see, speak, or hear in a standard office environment and independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. Ability to travel domestically and internationally is required.

Compensation

Salary Range: $170,200–$212,700 USD

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.

Benefits for 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, religion, gender identity, sexual orientation, disability, and other protected characteristics as defined by 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. To request or inquire about the reasonable accommodation, please use our Reasonable Accommodation Request Form.