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Technical Specialist, Manufacturing - DNA Small Scale

Employer
Moderna, Inc.
Location
Burlington, MA
Start date
Nov 23, 2022

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Job Details

The Role:

Moderna is seeking a Technical Specialist based at their Burlington, MA site. The individual in this role will be part of a cohesive team responsible for producing the DNA Plasmid used as a starting material for mRNA vaccines and therapeutics. The Technical Specialist uses expert knowledge of manufacturing practices, bioprocess unit operations, process engineering and digital systems to act as a technical leader for the manufacturing team. The Technical Specialist will be a key player in the development of operational procedures and training material, training manufacturing associates, supporting Tech Transfer activities, investigating issues that arise, and driving projects within the team focused on delivering Right First Time results in an efficient manner.

Heres What Youll Do:

  • Practice and promote safe work habits adhere to all safety procedures and guidelines

  • Provide on-the-floor coaching of the manufacturing team in execution of the process, troubleshooting, cGMPs, and safety practices

  • Serve as the manufacturing lead for tech transfers and other projects

  • Participate on and Lead cross-functional teams to drive complex manufacturing operation changes, improvements, and issue investigations

  • Work with process SMEs to develop batch records, SOPs, and training materials

  • Provide on-the-floor training of manufacturing staff

  • Closely partner with QA peers for rapid disposition of batches, including ensuring timely batch record, protocol, and log reviews, deviation investigation support, etc.

  • Support the investigation and own CAPA implementation for manufacturing deviations

  • Own and manage change controls for projects within the team

  • Own the purchasing and induction of simple equipment / tools

  • Serve as a key point of contact for Maintenance and Metrology

  • Own ops readiness for new product introductions, technology transfers, and major capital projects

  • Participate in equipment start-up, commissioning, and validation activities

  • Maintain a flexible schedule based on the demands of production and projects

  • Work independently with minimal supervision and direction

  • Escalate issues and constraints that have the potential to impact business objectives

Heres What Youll Bring to the Table (Minimum Qualifications):

  • 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.

  • Thorough knowledge and understanding of cGMPs

  • 2+ years experience with technical writing in a cGMP environment

Preferred Qualifications:

  • Subject Matter Expert on cell culture and gigaprep scale purification operations

  • 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 SAP, MES, etc.

  • 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

  • Background in lean manufacturing methodologies & operational excellence

  • Experience in cGMP inspections (with partner companies and/or regulatory agencies)

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.

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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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