Associate Director, Sterility Assurance - Personalized mRNA Cancer Vaccine

The Role:

In this role you will be designing, implementing, and driving an aseptic and sterility assurance program within Modernas growing Personalized mRNA Cancer Vaccine program at the Norwood, MA site. Reporting to the Sr. Director, Quality, the Associate Director, Sterility Assurance, will also be collaborating closely with Modernas global and site SA network and programs, driving standardization, harmonization, and best practice across sterile manufacturing operations. You will also deliver and drive continuous improvement of aseptic techniques/practices to ensure the sterility of Modernas clinical products.

Heres What Youll Do:

• Have in depth knowledge and expertise in aseptic processing and sterile operations including syringe/vial filling isolators and manual filling to assure adoption of best practice in aseptic processing

• Provide support to the sterile manufacturing site on all aspects of aseptic processing/behaviors and sterility assurance

• Provide advice/guidance and training for personnel to enhance aseptic practices and sterile production processes including the development and or review of training materials and curriculum

• Ensure alignment within Modernas network with the global microbiological/aseptic standards and compendial requirements

• Support inspections, partner audits etc. on-site and incorporate any lessons learned into Modernas sterility assurance program

• Perform proactive surveillance of global regulatory requirements (international and domestic), industry guidance and emerging trends of regulators to ensure Moderna policies and standards remain current and are benchmarked against best practices in the context of sterility assurance processes.

• Execute a holistic end to end program utilizing QBD and contamination control risk assessments to evaluate and certify Modernas sterile manufacturing clinical drug product site in aseptic processing and to assure the sterility of Modernas products.

• Provide input for the design of new Drug product facilities/lines to ensure cleanliness control and adequate aseptic manufacturing strategies.

• Performs regular GEMBA style assessments of aseptic and low bioburden manufacturing operations, assessing compliance of operations including identification of deficiencies and opportunities for improvement

• Provide technical support, in the context of SA processes:

  • for sites and product related inspections

  • to manufacturing and quality during manufacturing and/or laboratory deviation investigations, change control and CAPAs

  • through the development and / or technical review of site specific procedures, protocol, and policies in support of the sterility assurance program that supports personalized medicines.

  • This position is expected to work in a highly collaborative and cross-functional team environment (including Technical Development groups) also supporting sites in regulatory and third party/HA inspections.

  • The individual will also act as interdepartmental liaison to various groups including Manufacturing, Manufacturing Science and Technology, Quality Assurance, Global Quality Control, Regulatory and Technical Development. This position may be based at the Moderna, Norwood, MA facility.

  • This position will work collaboratively with the Global Sterility Assurance experts to achieve company objectives and ensure policy alignment across the organization.

Heres What Youll Bring to the Table:

• Bachelors degree with a minimum of 10 years of experience in the biotechnology or pharmaceutical industries, with 5+ years direct experience in sterile manufacturing or supporting sterile manufacturing.

• Knowledge and experience in personalized medicine manufacture a plus.

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 persons 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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