CMC Project Manager, R&D Integration and Program Management - Waltham, MA | Biospace
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CMC Project Manager, R&D Integration and Program Management

Alkermes

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Location:
Waltham, MA
Posted Date:
12/2/2016
Position Type:
Job Code:
7049
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Company Overview

Alkermes plc is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. The company has a diversified portfolio of more than 20 commercial drug products and a substantial clinical pipeline of product candidates that address central nervous system (CNS) disorders such as addiction, schizophrenia and depression. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and manufacturing facilities in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

Position Summary

Alkermes is seeking an R&D Project Manager with a strong technical drug product development background to support Chemistry, Manufacturing, and Controls (CMC) teams within our development portfolio. This person will work closely with the other pharmaceutical research and development areas, process development, manufacturing, supply chain, quality and regulatory to ensure development and execution of project plans to meet key corporate goals.

Key Responsibilities:

This person will play a key role in the management of cross functional activities within our CMC teams, partnering closely with team members as well as members of R&D senior management to orchestrate development of CMC plans, timelines, budgets, and ensure execution of project plans to meet key corporate goals. 

Areas of responsibility will include:

  • Facilitates development and execution of CMC project plans, including:
    • Integration of detailed execution and long-term development plans across the various CMC areas such as: API development and manufacturing, formulation development, process development, analytical method development and validation, manufacturing, quality, and CMC regulatory
    • Identification of critical program assumptions/activities/constraints
    • Supports team with optimization of plans by evaluating assumptions and incorporation of new inputs as the projects progress through development
    • Proactive management of project execution as well as potential risk areas, including identification and implementation of mitigation and/or contingency plans
  • Provides overall project management support to a CMC team/s, ensuring clear and open communication and fostering proactive cross-functional integration across CMC departments and company sites
    • Develops and maintains CMC program budgets and timelines, facilitates cross-functional logistics and manages project communications tools/documents used by the team and functional area management

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.

Requirements

Minimum Education & Experience Requirements:

  • BS/MS in a scientific or engineering discipline, with 8+ years of relevant pharmaceutical product development experience
  • 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-AB1

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.