Director or Senior Director, API Development

Benefits

Parental leave

Not verified

Non-birth-parent leave

Not verified

Family-building benefits

• Fertility benefits: Not verified
• Adoption assistance: Not verified
• Surrogacy assistance: Not verified

Mental health support

Not verified

Relocation assistance

Not verified

Childcare support

Not verified

Learning budget

Not verified

Verification

Not verified

Salary

$220K-$240K From the posting source

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Market context

U.S. role benchmark (BLS OEWS)

$116,543 U.S. median for this role

Projected growth (BLS Employment Projections)

+9.8% - Much faster than average

U.S. benchmark only; posted salary is not compared across countries or currencies.

Matched to SOC 15-1252 - Software Engineering aggregate by role bucket.

Source: U.S. Bureau of Labor Statistics, OEWS, May 2024 and Employment Projections, 2024-2034.

Role

Role function

Engineering From the posting source

Seniority

Staff Plus From the posting source

Work mode

Remote From the posting source

In-office days

0 days From the posting source

Schedule

Shift type

Not verified

Weekend work

Not verified

Company

Equity

Offered Verified - SEC 10-K source

Application

Cover letter

Not verified

Assessment

Not verified

Deadline

Not stated

Where they hire

State eligibility is not yet verified.

About this role

Director or Senior Director, API Development Remote Position Summary: We are seeking a Director or Senior Director, API Development, who will report to the Executive Director of Pharmaceutical Development. You will be the technical expert for current API synthesis production and will lead creation, optimization, and management of additional API entities as part of new compound/formulation development activities. Responsibilities: Provide leadership and technical guidance for selection, transfer, and management of new CDMO manufacturing activities. Lead current drug substance manufacturing process and optimize for continuous improvement of material. Support ongoing CDMO manufacturing activities and troubleshoot issues and non-conformities. Determine and resolve gaps for regulatory compliance with drug substance manufacturing and development. Support formulation development with drug substance optimization, impurity identification, and pre-clinical study coverage involvement. Author and review drug substance IND-enabling protocols, reports, and regulatory submissions. Engage and support formulation development with new entity optimization and synthetic route creation/advancement. Produce intellectual patent assessments and complete development projects intended for furthering IP generation. Other duties as assigned. Qualifications: PhD, Master's, or Bachelor's degree in a physical science field, ideally chemistry, chemical engineering, or biomanufacturing. ≥ 8 years in small molecule medicinal chemistry, API development, and/or manufacturing. Experienced with early development activities including IND-enabling development and authoring. Managed CDMOs for initial development, manufacturing, process validation, and transfer activities. Knowledge of analytical technologies including LC, GC, NMR, MS, XRPD, and other relevant methodologies used for elucidation and purity determination. Well-informed of FDA, EU, and ICH guidelines for drug substance manufacturing and quality assurance. Excellent

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