The individual in this role will be accountable for leading a team to support Commercial and Clinical operations. They will apply existing knowledge of bioprocess unit operations and cGMPs while learning the Moderna platform. This position will be inclusive of trouble shooting, document updates, procedure creations, batch review, readiness and close out activities. The supervisor uses knowledge of manufacturing biopharmaceutical unit operations, quality systems and digital infrastructure to drive continuous improvement. They will leverage knowledge of cGMP regulations to support investigations and improvement initiatives within manufacturing operations. Additional functions include acting as a responsible liaison between the Manufacturing group and other partner groups (MST, Facilities, Supply Chain, QA, etc.) This role will also work cross-functionally to assist in planning manufacturing activities, maintenance and calibration of equipment and instruments and provide oversight of batch close out work such as batch record review and completion. The successful candidate must have a good understanding of current regulatory, GMP and safety standards and be able to apply this knowledge in a GMP environment. They will enable technical and operational success while keeping employee safety and product quality front of mind. They will develop a high-performing, flexible manufacturing team capable of meeting a constantly evolving manufacturing operation timeline.
This position is located at our location in Norwood, MA. This position will be Monday to Friday, 8:00 AM - 5:00 PM.
Here's What You'll Do:
Here's What You'll Bring to the Table (Minimum Qualifications):
- Ensure batch records (inclusive of eBR, MBR, elogs, audit trails, trend reports, LIMS etc) are reviewed and product disposition timelines met
- Maintain production schedule, driving compliance (i.e., CAPAs, deviations, proactive initiatives, change controls, change actions, and effectiveness checks) and manufacturing owned actions
- Oversee the hiring, training, development, retention, coaching, and overall performance of staff for execution of manufacturing support operations
- Drive change and continuous improvement projects
- Provide coaching of the manufacturing support team in execution of the process, troubleshooting, cGMPs, and safety practices
- Escalate and drive resolution to issues that may impact operational safety, product quality, or ability to produce
- Work with process SMEs to develop/update batch records, digital platforms, procedures, and training materials
- Ensure the training of staff and adherence to established procedures
- Establish and maintain a Quality Culture within your team
- Play a key role in leading ops readiness for new product introductions and change overs
- Quickly adapt and maintain a flexible schedule based on the demands of production
- Monitor the achievement of business and financial goals, rapidly escalate when critical issues arise that impact our ability to meet those goals
- Collaborate cross-functionally with Technical SMEs (i.e., MST, Process Engineering), Facilities, Validation, Supply Chain, QA, and QC to meet business goals
- Requires BS in a relevant science or engineering discipline plus 5 years' experience in a biotechnology manufacturing/quality/development environment; or an MS with 2-5 years' experience; or 10+ years professional experience with 5 years' being in a biotechnology manufacturing/quality/development environment.
- Previous Supervisory / Leadership experience is required
- Thorough knowledge and understanding of cGMPs
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- Subject Matter Expert on RNA Manufacturing
- Excellent communication and presentation skills
- Strong leadership, collaboration, and team building skills
- Skill in conflict resolution and crucial conversations (within the team and between functions)
- Fluency in digital systems such as Infobatch, Syncade, SAP, DeltaV, MES, etc.
- Experience in both traditional stainless-steel and single use systems
- Strong understanding of manufacturing supply chain systems, including production planning, scheduling, and material management
- Proven ability to assess risk and collaborate with support groups to develop suitable action plans and minimize potential impact
- Experience in cGMP inspections (with partner companies and/or regulatory agencies)
- Highly competitive and inclusive medical, dental and vision coverage options
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
- Family care benefits, including subsidized back-up care options and on-demand tutoring
- Free premium access to fitness, nutrition, and mindfulness classes
- Exclusive preferred pricing on Peloton fitness equipment
- Adoption and family-planning benefits
- Dedicated care coordination support for our LGBTQ+ community
- Generous paid time off, including:
• Vacation, sick time and holidays
• Volunteer time to participate within your community
• Discretionary year-end shutdown
• Paid sabbatical after 5 years; every 3 years thereafter
- Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
- 401k match and Financial Planning tools
- Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
- Complimentary concierge service including home services research, travel booking, and entertainment requests
- Free parking or subsidized commuter passes
- Location-specific perks and extras!
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. 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 and approval 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 autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven 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.