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Director Formulation Development Jobs in California

Amgen

Process Development Senior Scientist

Thousand Oaks, CA · On-site

$96K - $131K/yr

Proven experience in formulation development, stability testing, and fill/finish operations for biologics; direct ADC drug product formulation experience is strongly preferred. * Demonstrated ...

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Director Formulation Development information

What is a Director Formulation Development?

A Director of Formulation Development leads the design and optimization of pharmaceutical formulations, ensuring they meet quality, regulatory, and performance standards. They oversee research, guide teams in developing new drug delivery systems, and collaborate with regulatory and manufacturing teams. This role requires expertise in chemistry, pharmaceutics, and process development to ensure successful product commercialization. Additionally, they manage project timelines, budgets, and technical challenges to drive innovation in drug formulation.

What does a Director Formulation Development do?

As a Director Formulation Development, you will oversee the design and optimization of drug formulations, lead a multidisciplinary team of scientists, and ensure that projects meet quality, budget, and timeline expectations. Your daily activities often include strategic planning, reviewing progress reports, troubleshooting formulation challenges, and collaborating with regulatory, manufacturing, and quality assurance departments. You may also interact with upper management to report on key milestones and contribute to long-term product development strategies. This role offers opportunities to influence project pipelines and play a central part in bringing new therapies to market.

What are the key skills and qualifications needed to thrive as a Director Formulation Development?

A Director Formulation Development typically requires an advanced degree in pharmaceutical sciences, chemistry, or a related field, along with significant experience in drug formulation and team management. Familiarity with industry-standard formulation software, regulatory compliance systems, and relevant certifications such as PMP or Six Sigma are highly valued. Excellent leadership, communication, and strategic planning skills help set high performers apart in this role. These skills and qualities are critical for driving innovative product development, ensuring regulatory compliance, and effectively leading cross-functional teams.

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Director Formulation Development jobs near you
Infographic showing various Director Formulation Development job openings in California as of September 2026, with employment types broken down into 89% Full Time, and 11% Contract. Highlights an 94% In-person, and 6% Hybrid job distribution.

Assistant Director / Associate Director, Pharmaceutical Development ‒ Regulatory Writing

Carlsbad, CA • On-site

Scorpion Therapeutics
51 - 200 employees
Learn more about Scorpion Therapeuticsexternal

Other

Posted 11 days ago

Job description

Assistant Director / Associate Director, Pharmaceutical Development — Regulatory WritingResponsibilities
  • Serve as primary author and/or coordinator for drug product CMC sections of regulatory submissions and supporting documents (INDs, IMPDs, NDAs, briefing packages, and responses to regulatory questions).
  • Translate technical data (formulation, drug product/device development and manufacturing, analytical testing, stability, specifications, control strategies) into clear, accurate, phase-appropriate regulatory narratives.
  • Partner with Pharmaceutical Development leads and cross-functional CMC teams to define authoring strategy, align messaging, identify data gaps early, and meet aggressive timelines.
  • Lead document planning, content integration, version control, review cycles, comment reconciliation, and finalization of submission-ready CMC documents.
  • Author and/or review technical documents supporting filings (development reports, justification documents, protocols, specifications, batch records, stability summaries, change assessments).
  • Develop and standardize templates, best practices, and authoring workflows to improve consistency/efficiency/quality.
  • Shape regulatory content for lifecycle changes, platform justifications, comparability arguments, and global expansion.
  • Communicate with internal stakeholders, external partners, and vendors to obtain data and resolve issues.
  • Support process development of drug product manufacturing and formulation development as needed.
Requirements
  • BA/BS+ in Pharmaceutical Sciences/Chemistry/Chemical Engineering/Biochemistry or related field; 8+ years (BA/BS), 6+ years (MA/MS), or 3+ years (PhD) drug product development preferred.
  • Sterile drug product development/manufacture experience; responsibility authoring CMC content for regulatory submissions.
  • Clear, persuasive regulatory writing; strong scientific rigor.
  • Experience authoring CMC technical and administrative documents within controlled documentation systems.
  • Good judgment interpreting data and resolving risks/inconsistencies.
  • Knowledge of FDA, ICH, USP, ISO and other relevant guidance.
  • Competent in relevant laboratory practices.
  • Excellent organizational, project management, and communication skills.
Benefits

Ionis provides an “excellent benefits package” (link: https://ionis.com/careers).

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