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Engineer II, Drug Product Development

Employer
Moderna, Inc.
Location
Norwood, MA
Start date
Nov 8, 2022

Job Details

The Role:

We are seeking a highly motivated Engineer II to join our Drug Product Development (DPD) team in Norwood, MA. This candidate will be responsible for technical development in container science and combination product development to advance Modernas exciting mRNA pipeline and technology platforms. From pre-clinical through commercialization, DPD is accountable for product image definition, formulation development, aseptic process development and characterization, container science, process scale up, and technology transfer. The specific focus of this position will be characterization and implementation of new primary container systems and combination products. This will include the development and manufacturing of prefilled syringe (PFS) combination products through appropriate Design Controls.

Here is What Youll Do:

  • Establish and execute integrated development plans for drug-device combination products (primarily PFS) starting from the Drug Product interface through label and packaging operations

  • Serve as the key interface connecting our internal development/quality/regulatory teams with various third parties (CDMOs, consulting groups, vendors, suppliers, etc)

  • Oversee the design, execution, and documentation of appropriate development, verification, and validation studies

  • Author/review combination product technical documentation including DHF documents, design input requirements, test plans/protocol/reports, engineering assessments, and design outputs

  • Perform required risk assessments, implement appropriate mitigation strategies, and document approaches through appropriate risk management systems

  • Advance platform and functional initiatives through direct contributions and matrixed leadership

  • Support authoring and review of regulatory submissions

Heres What Youll Bring to the Table:

  • Degree in Mechanical/Chemical/Biomedical Engineering or related discipline

  • Minimum of 2 years (PhD), 4 years (MS), 6 years (BS) industry experience in biopharmaceutical combination product development

  • Expertise in Design Controls for Combination Products

  • Hands-on experience with development of drug-device combination products (PFS and autoinjector)

  • Demonstrated success interfacing with third parties (CDMOs, consulting groups, vendors, suppliers, etc.)

  • Experience in additional device types (eg on-body infusers (OBI), nebulizers, pressurized metered-dose inhalers (MDIs), and dry powder inhalers (DPIs) is a big plus

  • Experience in project management approach to advance complex and fast-paced projects through matrixed (internal and external) teams

  • Solid understanding Good Manufacturing Practices (GMP), Risk Management, and US/Global medical device regulations

  • Familiarity with Human Factors studies

  • Ability to work independently and as part of a team in a highly dynamic, fast-paced, matrixed environment with rapidly evolving priorities

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 winter shut down
    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.

#LI-KP1

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Company

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. 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 and cardiovascular diseases, independently and with strategic collaborators.

mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”

Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.

 

Stock Symbol:

MRNA  

Stock Exchange:

USNASDAQ GS

 

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Company info
Website
Phone
617-714-6500
Location
200 Technology Square
Cambridge, MA
United States

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