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