Associate Director, Technical Operations - Drug Product

Location: Remote – US-based candidates only, no visa sponsorship available.

About the role

Lead operational priorities where safety, quality, compliance, and execution discipline are central to success. Collaborate with field leadership, support functions, and cross-functional stakeholders to improve accountability, service delivery, and operational consistency. Influence operational scale, customer outcomes, and organizational performance within a life sciences environment.

Responsibilities

• Oversee production, scale-up, and validation of small molecule drug products at CDMOs.
• Review and approve manufacturing documents including batch records and validation protocols.
• Verify processes' suitability and validation at external labs.
• Provide technical support for GMP manufacturing quality systems and regulatory submissions.
• Collaborate on CMC development and commercialization with internal and external teams.
• Author and review technical documents and regulatory filings (INDs, IMPDs, NDAs).
• Ensure CDMOs meet quality standards and contractual obligations.

Requirements

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or related field; advanced degree preferred.
• 8+ years of experience in small molecule drug product manufacturing, focusing on scale-up and commercialization.
• Experience with amorphous solid dispersions and solid oral drug product development.
• Expertise in process development, characterization studies, and commercialization of solid oral products.
• Experience managing global CDMOs and third-party manufacturers.

Benefits

• Premium health insurance and financial wellness offerings.
• Wellness and employee support programs.
• Life insurance and disability coverage.
• Retirement plans with employer match.
• Generous paid time off.

Pay

$150,000 – $195,000 annually.