Moderna is seeking a cGMP Sr. Manufacturing Associate based at their Cambridge, MA site. This position will transition to our new GMP Manufacturing site in Norwood, MA. This is a second shift position.
The individual in this role will be part of a cohesive team responsible for producing mRNA Manufacturing of Personalized Cancer Vaccines for evaluation in human clinical trials. This position will transition to our new GMP Manufacturing site in Norwood, MA. He/she will apply existing and new knowledge of bioprocess unit operations and cGMPs to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will be able to document and communicate their technical and operational observations clearly and efficiently. They will be able to operate pilot-scale bioprocessing equipment and interact fluidly with peers and supervisors in the Pilot Plant, and cross-functionally with Quality Control, Quality Assurance, Supply Chain, Process Development &Technology Transfer counterparts.
Here’s What You’ll Do:
- On-the-floor leadership and execution of daily unit operations.
- Help establish daily unit operations schedule that includes people, product, and material flow.
- Strict adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation.
- Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.
- Monitor process operations to ensure compliance with specifications.
- Complete tasks in support of personalized scale manufacturing, including in the care of high-value capital equipment, such as pilot-scale chromatography/TFF systems.
- Assist in the investigation of procedural deviations.
- Practice safe work habits and adhere to Moderna’s safety procedures and guidelines.
- Utilize knowledge to improve operational efficiency.
- Adhere to gowning procedures and maintain a clean general operating area.
- Adhere to documented waste handling procedures to respect environmental regulations.
Here’s What You’ll Bring to the Table:
- 5+ years of experience in a GMP manufacturing environment.
- Bachelors in relevant science or engineering discipline, or equivalent in work experience.
Here’s What We’ll Bring to the Table:
- Daily on-site catered lunches.
- Company-provided iPhone.
- Free parking, monthly subway pass or a subsidized commuter rail pass.
- 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.
- 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.
- Adoption assistance, competitive parental leave, discount to local childcare centers, as well as access to Care.com