Director, Formulation Development & CSP Leadership

Acadia Pharmaceuticals Inc.; Princeton (KY); Hybrid; USD 170,000 - 213,000; Full time

Benefits offered by this job

Competitive base salary

Health, dental, and vision insurance

Employer-paid life, disability, travel

EAP coverage

401(k) Plan with company match

Employee Stock Purchase Plan

15+ vacation days

Paid holidays

Paid sick time

Tuition assistance

Job summary

Acadia Pharmaceuticals seeks a Director of Formulation Development to lead formulation, primary packaging, and manufacturing process development across its drug portfolio, from early development through commercialization.

You'll manage CSPs, resolve complex technical issues, and advance manufacturing technologies to support clinical supply, process validation, and lifecycle management. The role emphasizes reducing risk, accelerating progress, and strong cross-functional collaboration.

Qualifications

• Advanced degree in Pharmaceutical Sciences or related field with at least 10 years of formulation and manufacturing process development experience.
• Proven ability to manage external development and manufacturing partners (CROs, CMOs, CSPs).
• Strong written and verbal communication and leadership across functions; willingness to travel domestically and internationally.

Responsibilities

• Design and oversee formulation development and manufacturing processes for clinical and commercial use.
• Evaluate and qualify CSPs for development, scale-up, and commercialization; manage related supplier agreements.
• Lead development and scale-up of clinical formulations and finished dosage forms at CSPs; provide on-site technical support when needed.
• Plan and direct scientific activities, interpret data, draw conclusions, and prepare technical reports for regulatory submissions.
• Align CSP manufacturing schedules with clinical supply needs to ensure uninterrupted material availability.
• Conduct risk assessments of processes and drive resolution with CSP partners.
• Prepare technical reports and regulatory documentation (CMCs) to support filings and approvals.
• Collaborate with analytical, manufacturing, quality, and regulatory teams on development plans and lifecycle management.
• Ensure compliance with cGMP and other GxP requirements; support CSP readiness for inspections.

Skills

Formulation development

Primary packaging

Manufacturing process development

CSP management

Technical leadership

Regulatory readiness

Cross-functional collaboration

Travel flexibility

Education

Advanced degree in Pharmaceutical Sciences or related field

Job description

Acadia Pharmaceuticals seeks a Director of Formulation Development to lead formulation, primary packaging, and manufacturing process development across its drug portfolio, from early development through commercialization.

You'll manage CSPs, resolve complex technical issues, and advance manufacturing technologies to support clinical supply, process validation, and lifecycle management. The role emphasizes reducing risk, accelerating progress, and strong cross-functional collaboration.