Acadia Pharmaceuticals Inc.

Director, Formulation Development

Princeton, New Jersey, United States · Director

Sponsorship not specified$170k-$213kDetected 12 days ago
RecruitingCustomer SupportGMPFDA RegulatoryLeadershipCommunicationPublic SpeakingGxP

About the role

  • 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.
  • This role plays a key part in reducing development risk, improving execution, and accelerating program progression.
  • Plan and direct scientific and technical activities, including data interpretation, evaluation of results, development of conclusions, and preparation of technical reports and presentations

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
  • 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
  • We are committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the BEST candidate for the job.

Requirements

  • Ability to travel domestically and internationally is required.
  • Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or a related field required
  • Minimum of 10 years of progressively responsible experience in formulation and manufacturing process development, including leadership responsibilities.
  • Strong knowledge of cGMP requirements and experience supporting regulatory filings, including NDAs or other marketing authorization applications
  • Strong written and verbal communication skills, with the ability to translate complex technical information for cross-functional audiences

Skills

  • Education, Experience, and Skills

Compensation

  • $170,200 - $212,700 USD

Benefits

  • Competitive base, bonus, new hire and ongoing equity packages
  • Medical, dental, and vision insurance
  • Employer-paid life, disability, business travel and EAP coverage
  • Employee Stock Purchase Plan with a 2-year purchase price lock-in
  • 15+ vacation days
  • Paid parental leave benefit
  • Tuition assistance

Equal opportunity

  • 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.
  • 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.
  • As an equal opportunity employer, Acadia is committed to a diverse workforce.

Visa & Work Authorization

  • 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 condi
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This listing is sourced directly from Acadia Pharmaceuticals Inc.'s careers page and normalized into a canonical job model.