Reporting to the Manager Manufacturing, this individual will be part of a cohesive team responsible for producing high quality mRNA-based medicines for evaluation in human clinical trials. The Manufacturing Specialist uses expert knowledge of cGMP regulations and downstream biopharmaceutical production processes to manage investigations and improvement initiatives within manufacturing operations.
Here's What You'll Do:
Practice and promote safe work habits and adheres to safety procedures and guidelines
Utilizes manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues and drive continuous improvement in process operations
Lead cross functional teams to drive complex investigation close outs, determine root causes and implement appropriate corrective and preventive actions
Conducts document revisions and/or document management including batch production records and manufacturing procedures
Performs training with staff on the floor, as needed
Leads cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology
Works independently with minimal supervision and direction
Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion
Monitors production processes
Participates in equipment start-up, commissioning, and validation activities
Ensures equipment operational readiness
Assists with troubleshooting in case of equipment failure
Here's What You'll Bring to the Table:
Bachelor's Degree with 5-8 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
Subject matter expertise in biologics drug substance purification operations (liquid chromatography, TFF, aseptic technique) or a similar complex specialized environment
A comprehensive understanding of regulatory requirements and their applications in a cGMP environment
Minimum of 2 years' experience with deviation/investigation management systems or a similar technical writing system in a cGMP environment
Excellent written and oral English language skills
Demonstrated ability to lead cross functional teams and deliver results with minimal supervision
Ability to manage multiple competing priorities in a fast-paced environment
Experience working with electronic batch records and thorough understanding of 21 CFR part 11 requirements
Background in lean manufacturing methodologies and operational excellence
Experience interacting with representatives of regulatory agencies
Project management experience
Here's What We'll Bring to the Table:
On-site subsidized cafeteria
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)
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. Moderna's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.
Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. (NASDAQ: AZN) and Merck, Inc. (NASDAQ: MRK), as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been named a top biopharmaceutical employer by Science for the past five years. To learn more, visit www.modernatx.com.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
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.