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Assoc. Director/Senior Manager, Manufacturing Central Services at Moderna Therapeutics

Posted in Other 30+ days ago.

Type: Full Time
Location: Norwood, Massachusetts





Job Description:

The Role:
Moderna is seeking a Senior Manufacturing Manager / Associate Director of Central Services. He/She is accountable for the leadership of Moderna s Buffer Preparation, Material Handling and future Equipment Preparation teams. The individual in this role will lead these newly formed and expanding teams through initial scale up and through operational excellence. 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 respecting global regulatory expectations. They will play a vital role in the continuing operations and maturation of our new Norwood, MA facility by developing SOPs, improving electronic batch records and training materials. They will hire, train, develop and retain a high-performing, flexible manufacturing team capable of meeting a fast manufacturing operation timeline.

Here s What You ll Do:
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Lead teams that safely produce buffers, kit and transfer materials to make mRNA medicines for clinical trials including Moderna s new COVID-19 vaccine
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Ensure plans and resources (people, facilities, supplies etc.) are efficiently utilized to manufacture and deliver on time to the clinic
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Oversee the hiring, training, development, retention, and performance of staff for the leadership and execution of manufacturing operations.
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Eliminate waste in the process leveraging lean concepts (value stream mapping, 5S)
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Develop batch records, SOPs and training materials for the Norwood Facility
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Closely partner with QA peers for rapid disposition of mRNA medicines
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Develop comprehensive operating plans and monitors the achievement of business and financial goals.
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Ability to manage multiple projects in a fast-paced environment
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Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment
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Leverage Lean and Six Sigma principles to foster and drive a culture of continuous improvement

Here s What You ll Bring to the Table:
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A BS in engineering or sciences and 10+ years of experience in all manufacturing processes in a pharmaceutical or biotechnology environment.
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Previous management or project experience is required
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Subject Matter Expert on Bioprocess equipment.
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Strong inventory management / MES background
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Technical writing skills and proficient in investigations and root cause analysis.
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Experienced with cGMP

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:
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. The Company s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna 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. and Merck, Inc., 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) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been ranked in the top ten of Science s list of top biopharma industry employers for the past five years. To learn more, visit .

Our Mission:
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.
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