External Manufacturing Specialist

Company: Moderna
Location: Norwood
Posted on: September 17, 2020

Job Description:

The Role: Reporting to the Senior Manager of US External Manufacturing Fill Finish, the Specialist/ Engineer II will be part of a team responsible for Moderna's manufacturing activities at 3rd-party contract manufacturing organizations (CMO), with a focus on fill finish. Here's What You'll Do: - Ensure operational and technology transfer activities are performed completely and compliantly at CMOs to deliver a quality product and meet Moderna requirements - Ensure externally manufactured drug products are produced and stored according to the appropriate documentation in order to obtain the required quality. - Review instructions relating to external production operations and ensure their strict implementation by the CMOs - Ensure in collaboration with quality that the appropriate qualification, maintenance, trainings and validations are performed to meet the appropriate Moderna's requirements. - Coordinate and perform the reviews for process performance and Key Performance Indicators at FF CMOs. - Drive for and implement agreed continuous improvements at FF CMOs. - Coordinate reviews and approvals of various documentations from FF CMOs. - In collaboration with Quality, Technical Development, and MS & T, coordinate investigations and troubleshooting efforts at FF CMOs. - Write or revise the appropriate GMP documentations. - Frequently visit and maintain presence at the external partners' sites (as global travel situation allows). - Performs other administrative duties as required. Here's What You'll Bring to the Table: - Bachelor's degree in Engineering or Sciences and 2 - 5 years or MS with 0 - 2 years of industry experience. - Considerable understanding of concepts and principles related to fill finish is preferred - Excellent communication skills (verbal and written) to collaborate with CMC Management in a dynamic, cross-functional matrix environment. - Well organized - a natural ability to be organized in how you think, communicate and conduct your work - You drive for results - you set a high bar for yourself and others - Good critical thinker that can anticipate the needed next step and therefore can work independently - A curious mindset that allows you to constantly learn and challenge the status quo - Ability to navigate through ambiguity and rapid growth and adapt to change. Here's What We'll Bring to the Table: - On-site subsidized cafeteria or catered lunches - Company-provided iPhone - Free parking, monthly subway pass or a subsidized commuter rail pass - Free annual corporate membership to Bluebikes - Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP - Flexible Spending Accounts for medical expenses and dependent care expenses - 16 weeks of 100% paid parental leave for all new parents - 16 weeks 100% paid family caregiver leave - 20 weeks 100% paid medical leave - Eligible for Moderna Month (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter) - Adoption assistance and discounts to local childcare centers, as well as access to - 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately - A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability - Voluntary legal assistance plan - 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)

Keywords: Moderna, Boston , External Manufacturing Specialist, Other , Norwood, Massachusetts