Associate Director, External Operations API

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 checked Jun 13, 2026

Salary

$160K-$180K From the posting source checked Jun 20, 2026

401(k) match

Reported from DOL Form 5500 industry filing (not employer-specific)

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Market context

U.S. role benchmark (BLS OEWS)

$61,842 U.S. median for this role

Projected growth (BLS Employment Projections)

+1.9% - Slower

175% above the BLS role benchmark for operations aggregate.

Matched to SOC 11-1021 - Operations aggregate by role bucket.

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

Role

Role function

Operations From the posting source checked Jun 20, 2026

Seniority

Director Plus From the posting source checked Jun 20, 2026

Schedule

Shift type

Not verified

Weekend work

Not verified

Company

Company stage

Public-company From the posting source checked Jun 20, 2026

Equity

Offered Verified - SEC 10-K source checked Jun 20, 2026

Application

Cover letter

Not verified

Assessment

Not verified

Deadline

Not stated

Where they hire

State eligibility is not yet verified.

About this role

Associate Director, External Operations API Waltham, MA, United States Associate Director, External Operations API API process expert responsible as the technical lead representative supporting API manufacturing at Contract Manufacturing Organizations' (CMO's) and subsequent processing of API's in Drug Product (DP) processes across OSD and injectables. Required to support new product introductions, technology transfers, continually monitor and improve API operations conducted at CMO's on behalf of Alkermes. Responsibilities General Review and maintain Alkermes practices & systems in managing contract manufacturers to ensure compliance with cGMP, and other regulatory requirements - ensuring that appropriate policies, rules, regulations and agreements are followed. Understanding of chemical processes from both scientific and engineering perspective demonstrating expertise in how API processes are developed and controlled to maximize yield and minimize impurities. Perform trending on CMO API processes and identify opportunities for continuous improvement providing technical leadership to implement such improvements to deliver on safety, efficiency and/or compliance. Oversee activities related to API production across the commercial supply network including routine production and associated monitoring/control plans as well as investigations, change controls and CAPA's ensuring processes are robust, efficient and in control. Understand and identify key chemical and physical attributes of API material as it pertains to downstream processing in the drug product process. For new processes ensure that the process is well defined with appropriate identification of CQAs and CPP's with appropriate measurement of both. In conjunction with Commercial Supply Chain oversee network optimization to include vendor selection and technology transfers/validations as required. Maintain the process

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