Engineer III/ Sr. Engineer I, Sterile Technology

Employer
Moderna
Location
Norwood, MA
Salary
Competitive
Posted
March 07 2019
Ref
R1405
Discipline
Life Sciences, Biology
Organization Type
Biotech
Engineer III/ Sr. Engineer I, Sterile Technology

The Role:

Moderna is working to develop first-in-class messenger RNA (mRNA) based medicines. Sterile Process Technologies, a process development team residing in Moderna's Technical Development organization, has been tasked with development and implementation of processes to enable high quality and cost effective sterile drug product filling for personalized manufacturing applications.

Reporting to the Principal Engineer of Sterile Technology, we seek a highly-motivated Sterile Technology Engineer III / Senior Engineer I to support development of sterile drug product processes for our Personalized Cancer Vaccine (PCV), both internally and with Moderna's Contract Manufacturing Organizations (CMOs). The incumbent will be responsible for early and late stage technical development of Personalized Cancer Vaccine fill and finish activities, which may include evaluation of novel container closure systems that may be suitable for small-batch, personalized manufacturing, as well as scale-down and scale-out of filling activities. The successful applicant will work closely with scientists and engineers in Moderna's Process and Analytical Development Departments, as well as the Personalized Vaccines Unit that spans Technical Development, Manufacturing, QC, QA and Supply Chain, to develop, transfer, and support the implementation of best-in-class sterile technology processes. Applicants should have experience in aseptic processing, tech transfer, visual inspection, and fill/finish process development/characterization.

Here's What You'll Do:
  • Oversee process development related to fill/finish packaging and labeling for Personalized Cancer Vaccine products, including assessment of container closure systems novel to Moderna, and scale-down/scale-out of drug product manufacturing (e.g. Fill/finish, Filtration).
  • Serve as subject matter expert on complex aseptic liquid filling applications. Equipment includes state-of-the-art, highly automated systems, as well as traditional, legacy systems.
  • Author and review technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions.
  • Develop protocols to evaluate the compatibility of the drug product with processing materials, container closure components, and sterilization processes.
  • Act as the sending unit for technology transfer of PCV drug product processes. Serve as person-in-plant, where applicable.
  • Serve as subject matter expert on particulate control and visual inspection processes across Moderna's PCV fill/finish operations.
  • Implement screening, sizing, implementation, and phase-appropriate validation activities for sterilizing grade liquid filters in support of fill finish activities.
  • Ensure that assigned processes are cGMP compliant and are designed to meet the regulations of the U.S FDA and the EMEA.


Here's What You'll Bring to the Table:
  • BS/MS/PhD in Biochemical Engineering, Chemical Engineering or related Scientific/Engineering field.
  • Experience: 0 to 2 years post Doctoral Degree or 2 to 8 years post Master's Degree or 5 to 10 years post Bachelor's degree. Experience in BioPharma, BioPharmaceutical, Pharmaceutical, or Biotechnology industry preferred.
  • Hands-on experience with aseptic liquid filling of vials, pre-filled syringes, and/or cartridges. Familiar with current varieties and suppliers of parenteral container closure systems.
  • Expertise with bringing new biotech products to market across various dosage forms and device delivery systems.
  • Knowledge of statistical design of experiments (DoE) and analysis.
  • Working knowledge of relevant FDA, EU, ICH guidelines and regulations.
  • Knowledge of GMP regulations, Process Validation/Qualification principles, and aseptic processing principles.
  • Experience with process scale-up/scale-down/scale-out and technology transfer of FDA-regulated manufacturing processes.
  • Hands-on experience with sterile filtration unit operations and a variety of filter membranes and manufacturers. Experience working with filter manufacturers on the design of microbial retention screenings/validations is expected.
  • Preferred: Fluent in PDA Technical Reports 22, 26, 60, and 79
  • Preferred: Experience with aseptic lyophilization.
  • Preferred: Combination product expertise.
  • Preferred: Experience with nanoparticle formulations
  • Preferred: Knowledge of nucleic acid chemistry and biology


Here's What We'll Bring to the Table:
  • Daily on-site catered lunches
  • Company-provided iPhone
  • Free parking, monthly subway pass or a subsidized commuter rail pass
  • 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
  • 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


Why join Moderna Therapeutics

We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured - at a breadth, scale and speed not common in the biopharma industry.

Since our founding in 2011, we have built the industry's leading mRNA technology platform , the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline , and an unparalleled team . Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage.

We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world.

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

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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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