Job Description:

Position Summary:

Alkermes is seeking a CMC Program Manager with a strong technical background in small molecule drug product development to support Chemistry, Manufacturing, and Controls (CMC) teams within our development portfolio. This person will partner with CMC Leaders and work closely with team members and leadership from R&D and Operations functional areas including formulation development, process development, manufacturing, supply chain, external operations, analytical, quality and regulatory to ensure development and execution of CMC project plans to meet key corporate goals.

Key Responsibilities:

This person will play a key role in the management and integration of cross functional CMC activities partnering closely with team members as well as functional leads to orchestrate development and ensure execution of CMC plans, timelines, and budgets that are aligned with CMC and overall program strategy.

Areas of responsibility will include:

• Facilitating development and execution of CMC project plans by ensuring:
  
  
  
  • Identification of critical program assumptions/activities/constraints
  
  
  • Integration of detailed execution and long-term development plans across the various CMC areas such as: drug substance development, drug product formulation and process development, analytical method development and validation, manufacturing, release, material characterization and stability testing, product control strategy, CMC regulatory interactions, and report/submission planning and execution
  
  
  • Proactive analysis of potential risk areas, including identification and implementation of mitigation and/or contingency plans
  
  
  • Optimization of plans and incorporation of new inputs as CMC programs progress through development, commercialization and lifecycle management
  
  
  
  


• Maintaining alignment between the CMC teams and leadership through:
  
  
  
  • Managing CMC program communication tools/documents
  
  
  • Ensuring integration of CMC plans with over-arching program plans
  
  
  • As needed, supporting external vendor oversight, contract development, and spend management
  
  
  
  


• Contributing to the establishment and enhancement of CMC project management tools and best practices to ensure we are providing effective PM support to the teams &/or the organization.


• Providing overarching project management support to a CMC teams, fostering an environment that encourages clear and open communication, strong collaboration across departments and sites, curiosity and ingenuity, discussion of challenges &/or opportunities, and problem solving with an enterprise mindset


• Developing and maintaining CMC program budgets and timelines

We're looking for an individual who values the team dynamic, is organizationally savvy, excels in a matrixed-management/leadership environment, and enjoys working on the details without losing site of the larger organizational goals.

Basic Requirements:

• BS/MS in a scientific or engineering discipline, with 10+ years of relevant pharmaceutical product development experience

Preferred Requirements:

• Prior experience managing cross functional teams with timeline management and budgetary responsibility


• Prior experience working on regulatory submissions


• Expert knowledge of MS Project and MS Excel


• Exceptional verbal/written communication, time/resource management, attention to detail, interpersonal and organization skills

#LI-HB1

About Us

Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).

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.

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