Full-time Director, External Development & Manufacturing, Alkermes

This position is responsible for leading key Pharmaceutical Development

activities that enable effective execution of Alkermes drug development

programs. Core responsibilities include business oversight of contract

development and manufacturing organizations (CDMOs) involved in development

activities and manufacturing of Alkermes drug development candidates through the

end of Stage 1 process validation, with appropriate transition of

responsibilities to Technical Operations as programs progress toward Stage 2

process validation. The role also provides operational leadership for monthly

scheduling of the Waltham Clinical Manufacturing Facility to ensure alignment of

development, manufacturing, clinical supply, and program priorities. This

individual will support Pharmaceutical Development operations by tracking

project progress and deliverables, onboarding new CDMOs, managing contracts,

coordinating resource and facility planning, and working with CMC Project

Managers to monitor budgets, timelines, and operational risks. These

responsibilities require strong cross-functional collaboration with

Pharmaceutical Development SMEs, CMC Teams, Clinical Supply, Strategic Sourcing,

Finance, EHSS, Quality, Technical Operations, Project Management and other key

stakeholders. The candidate will have strong scientific and operational skills,

excellent communication skills, and the ability to thrive in a matrixed,

cross-functional team environment.

02RESPONSIBILITIES

• Lead Pharmaceutical Development activities that support execution of
• development programs, including CDMO oversight, clinical materials demand
• forecasting, facility scheduling, and operational planning.
• Act as the primary business point of contact with CDMOs to facilitate the
• integration of CDMO activities within CMC teams and ensure on-time, in-full
• delivery of development and manufacturing commitments.
• Manage CDMO timelines, deliverables, and performance expectations against an
• established CDMO Governance Model to support product quality, program
• objectives, and development-stage commitments.
• Lead the monthly scheduling process for the Waltham Clinical Manufacturing
• Facility, balancing program priorities, resource availability, equipment
• capacity, material readiness, and operational constraints.
• Facilitate alignment among Pharmaceutical Development, Clinical Supply, CMC
• Project Management, Quality, and manufacturing stakeholders to proactively
• identify and resolve demand, capacity, and scheduling conflicts.
• Manage submission of Alkermes RFPs and CDMO SOWs.
• Act as the primary Pharmaceutical Development liaison with Legal, working
• with key stakeholders on contracts for new and existing CDMOs, including
• supply agreements, confidentiality agreements, purchase orders, and related
• business documents.
• Establish and monitor Key Performance Indicators (KPIs) for CDMOs and
• coordinate periodic reviews of process performance, operational performance,
• and KPI metrics.
• Coordinate preparation of periodic business and operational review meetings
• with CDMOs.
• Assist in CDMO selection activities, working with SMEs in Pharmaceutical
• Development, Strategic Sourcing, Finance, EHSS, Technical Operations, and
• Quality, as applicable, to prepare competency assessments and support robust
• decision-making.
• Analyze business opportunities and challenges with CDMOs involved in Stage 1
• development activities; provide financial and strategic analyses of decision
• options and make recommendations to senior management.
• Interface with internal Pharmaceutical Development SMEs, Project Management
• and CMC Teams on CDMO activities, clinical materials planning, and
• development manufacturing operations.
• Partner with Pharmaceutical Development SMEs on managing CDMO relationships
• and internal operational processes.
• Work closely with Technical Operations on CDMOs supporting Phase 3 activities
• through the end of Stage 1 process validation, with transfer of
• responsibilities to be finalized at the start of Stage 2 process validation.
• Identify and implement operational improvements, tools, and best practices to
• strengthen planning, scheduling, governance, and cross-functional execution
• within Pharmaceutical Development.
• Stay current in external trends and best practices relevant to pharmaceutical
• development operations, CDMO management, clinical supply planning, and
• development manufacturing operations.
• Knowledge/Skills Required:
• Exceptional oral and written communication skills.
• Strong project management, operational planning, and cross-functional
• facilitation abilities.
• Strong analytical skills with the ability to translate development program
• needs, clinical demand assumptions, manufacturing capacity, and material
• constraints into actionable plans.
• High level of technical knowledge of development manufacturing operations,
• facility capabilities, plant equipment, and operational constraints.
• Significant knowledge of cGMPs and applicable regulatory guidance.
• Ability to lead recurring governance processes, including demand forecasting,
• manufacturing scheduling, business reviews, and operational issue resolution.
• Demonstrated ability to interact and collaborate within an interdisciplinary
• team environment on creative problem solving, prioritization, and operational
• decision-making.
• Ability to influence without direct authority and drive alignment across
• technical, clinical supply, quality, finance, sourcing, and manufacturing
• stakeholders.

03QUALIFICATIONS

• Ph.D., M.S., or B.S. in a scientific, engineering, pharmaceutical sciences,
• or related discipline with 10+ years of relevant pharmaceutical or
• biotechnology industry experience.
• Previous process development, clinical manufacturing, pharmaceutical
• operations, and/or manufacturing experience preferred.
• Experience with clinical materials planning, demand forecasting, supply
• planning, production scheduling, or related operational planning processes
• preferred.
• Demonstrated capability to effectively manage technical, operational, and
• business details across multiple programs and stakeholders.
• Experience working with outsourced CDMOs in a business oversight capacity.
• Alkermes has recently adopted a hybrid working environment to support and meet
• the needs of employees and this role will operate in a flexible environment with

60% of time in the office and 40% from home. This position is eligible for the

hybrid workplace model, requiring work to be completed onsite at our Waltham, MA

office at least 3 days per week. This role is not eligible for fully remote

work.

The annual base salary for this position ranges from $216,000 to $235,000. In

addition, this position is eligible for an annual performance pay bonus.  Exact

compensation may vary based on skills, training, knowledge, and experience.

Alkermes offers a competitive benefits package.  Additional details can be found

04on our careers website: www.alkermes.com/careers#working-here

[http://www.alkermes.com/careers]

05#LI-MB1

• Why join Team Alkermes?
• Alkermes applies its decades of deep neuroscience expertise to develop medicines
• designed to help people living with complex and difficult-to-treat psychiatric

and neurological disorders. A global biopharmaceutical company, headquartered in

Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a

meaningful difference in the way people manage their diseases. We have a

portfolio of proprietary commercial products for the treatment of alcohol

dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy,

and a pipeline of clinical and preclinical candidates in development for various

psychiatric and neurological disorders.

We are proud to have been recognized as an employer of choice by many national

organizations. In 2024 and 2025, we were certified as a Great Place to Work in

the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe,

a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier

and recognized as a Best Place to Work in BioPharma by Fortune Magazine.

Alkermes, Inc. is an equal employment opportunity employer and does not

discriminate against any qualified applicant or employee because of race, creed,

color, age, national origin, ancestry, religion, gender, sexual orientation,

gender expression and identity, disability, genetic information, veteran status,

military status, application for military service or any other characteristic

protected by local, state or federal law.  Alkermes also complies with all work

authorization and employment eligibility verification requirements of the

Immigration and Nationality Act and IRCA.  Alkermes is an E-Verify employer.