Specialist/Engineer II, External Manufacturing Details

Specialist/Engineer II, External Manufacturing

Moderna - Norwood, MA

Employment Type : Full-Time

The Role:

Reporting to the Associate Director External Manufacturing, this individual will be part of a team responsible for Moderna’s manufacturing activities at 3rd-party contract manufacturing organizations (CMO).

Here’s What You’ll Do:

• Partner with Technical Development, Supply Chain, Quality, and Regulatory to support GMP production activities at Moderna’s critical material CMOs/suppliers.

• Ensure operational and technology transfer activities are performed completely and compliantly at CMOs to deliver a quality product and meet Moderna requirements

• Coordinate CMO/supplier team, including scheduling and facilitating meetings, sending out agendas, writing and distributing minutes, managing team documentation, and tracking goals and action items

• Coordinate reviews and approvals of various documentations from CMOs

• Collaborate with internal cross-functional team to own and drive forward internal change controls to support process, equipment, specification, and/or packaging changes at the CMOs

• Collaborate with Technical Development and External Quality to coordinate investigations and troubleshooting efforts at CMOs. Initiate and own internal deviations as required

• Drive for and implement agreed continuous improvements at CMOs

• Coordinate and perform the reviews for process performance and Key Performance Indicators at CMOs

• Collaborate with Technical Development, External Quality, and Supply Chain to support batch release, shipping, and disposition activities at CMOs as applicable

• Collaborate with Supply Chain, Finance, Logistics, and Accounts Payable to ensure on-time invoice payment

• Author and revise SOPs and/or other GMP and non-GMP documentation as required

• Frequently visit and maintain presence at the external partners’ sites, as the global travel situation allows.

• Performs other administrative/managerial duties as required.

Here’s What You’ll Bring to the Table:

• Bachelor's Degree with 2-5 years of experience in biopharmaceutical operations or a Master’s Degree with 0-2 years industry experience; Degree in Engineering or Life Sciences is preferred

• Project management experience is preferred

• Comprehensive understanding of regulatory requirements and their applications in a cGMP environment

• Excellent written and oral English language skills

• Demonstrated ability to lead and support cross-functional teams and deliver results with minimal supervision

• Ability to manage multiple priorities in a fast-paced environment

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 care.com
• 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)

About Moderna:

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com .

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.