Director, Formulation Development

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

Benefits offered by this job

Competitive salary

Bonus and equity packages

Medical, dental, and vision insurance

401(k) Plan with company match

15+ vacation days

Paid parental leave benefit

Tuition assistance

Job summary

ACADIA Pharmaceuticals Inc. in Princeton, NJ, is seeking a Director of Formulation Development. This role leads formulation and packaging development for drug candidates, emphasizing oral solid dosage forms. Responsibilities include managing external partners, ensuring compliance with regulatory standards, and overseeing clinical formulation development.

The ideal candidate holds an advanced degree and has over 10 years of relevant experience. The position also offers a flexible hybrid working arrangement and a competitive salary range between $170,200 and $212,700 USD.

Qualifications

• Minimum 10 years of experience in formulation and manufacturing process development.
• Proven success in managing external partners for product development.
• Strong knowledge of cGMP and regulatory submissions.

Responsibilities

• Lead formulation design and process development for clinical submissions.
• Evaluate and manage Contract Service Providers (CSPs).
• Conduct risk assessments and ensure compliance with standards.

Skills

Leadership

Technical report writing

Project management

Oral solid dosage form development

Regulatory submissions

Education

Advanced degree in Pharmaceutical Sciences or related field

Tools

cGMP

Regulatory standards

Job description

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.

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, and Skills

• 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

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 abstract, cross-functional challenges, develops methods and evaluation criteria for projects and programs, and partners with management on matters affecting the functional area. The role operates with a high degree of judgment in selecting approaches, allocating resources, and resolving issues of diverse scope. Decisions have significant impact on project execution, functional performance, and broader organizational outcomes.

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.

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: $170,200-$212,700 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 [e-mail] 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.

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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.