Associate Director, Manufacturing Specialists, PCV
ModernaTX, Inc.

Norwood, Massachusetts

This job has expired.


The Role:

Moderna is seeking a Sr. Manager/AD of Manufacturing Specialists for the personalized cancer vaccine site. He/She is accountable for the development, implementation, and ongoing support of manufacturing quality systems and production activities. The individual in this role will lead a cohesive team responsible for supporting complex investigations, root cause analysis, change management and continuous improvement across multiple cGMP manufacturing teams and support functions. He/she will apply existing and new knowledge of bioprocess unit operations and cGMPs to enable technical troubleshooting 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 personalized cancer vaccine site in Norwood, MA by developing SOPs, improving electronic batch records and training materials, and working with engineering to maintain equipment. They will hire and develop and retain a high-performing, flexible manufacturing specialist team capable of maintaining a fast manufacturing operation timeline.

Here's What You'll Do:

  • Promote safety and compliance throughout GMP manufacturing
  • Utilize process knowledge and expertise to lead the manufacturing specialists in complex investigations, identifying and resolving manufacturing issues and driving continuous improvement
  • Resource planning (people, facilities, supplies etc.) to ensure efficient utilization to support the manufacture of mRNA medicines and deliver on time to the clinic
  • Oversee the hiring, training, development, retention, and performance of staff for the leadership and execution of manufacturing specialist operation.
  • Develop and maintain batch records, SOPs and training materials for the personalized cancer vaccine site
  • Closely partner with QA peers for rapid disposition of our products
  • Develop cross-functional investigational, root cause analysis and continuous improvement teams that span across all GMP departments
  • Lead the optimization, trending, and reporting of manufacturing process operational parameters for manufacturing campaigns and daily metrics
  • Ability to manage multiple projects in a fast-paced environment
  • Collaborate and lead effectively in a dynamic, cross-functional matrix environment
  • Leverage Lean and Six Sigma principles to foster and drive a culture of continuous improvement across the Value Stream

Here's What You'll Bring to the Table:
  • A BS in engineering or sciences and 10+ years of experience in cGMP manufacturing processes in a pharmaceutical or biotechnology environment; 8+ years with a Masters. Title is contingent on experience.
  • Previous leadership role leading and developing teams
  • Project management experience
  • Capable of working in a range, from developing strategy to tactical support
  • Strong communication skills, working across a dynamic and complex operation
  • Subject Matter Expert on root cause analysis, complex investigational tools, change management and continuous improvement execution.
  • Technical writing skills and proficient in GMP manufacturing processes including but not limited to TFF Systems, Chromatography systems, single-use process materials/consumables use, fermentation and cell banking operations.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
  • 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.

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