Engineer I / II, Sterile Product Technology

Employer
Moderna
Location
Norwood, MA
Salary
Competitive
Posted
July 27 2019
Ref
R1622
Discipline
Life Sciences, Biology
Organization Type
Biotech
Engineer I / II, Sterile Product Technology

The Role:

Moderna is seeking a highly skilled and motivated Engineer I/II in Sterile Product Technology, a process development team residing in Moderna's Technical Development organization, to support mRNA lipid nanoparticle (LNP) process development that enables our clinical supply. The applicant will play a critical role helping bring medicines to patients as Moderna's portfolio begins to shift towards late-stage development. The primary role for this position will be to support fill/finish process development and scale-up work, with eventual ownership of experimental design and execution. The applicant will collaborate closely with Technical Development, Pre-clinical and GMP Production, Quality, and Drug Product Analytical Development groups on innovative process development efforts. Applicants should have relevant pharmaceutical experience with fill/finish processes and drug product development. The applicant should have strong communication and collaboration skills, along with multiple examples of a strong technical background.

Here's What You'll Do:
  • Conduct screening, sizing, implementation, and phase-appropriate validation activities for sterilizing grade liquid filters in support of fill finish activities.
  • Develop protocols to evaluate the compatibility of the drug product with processing materials, container closure components, and sterilization processes.
  • Perform a range of routine and non-routine analytical characterization techniques, including opacity testing, microscopy, DLS, etc.
  • Support scale-up/scale-down of drug product manufacturing (e.g. fill/finish, Freeze/thaw)
  • Support implementation and maintenance of procedural controls for development fill/finish operations.
  • Develop processes suitable to ensure long-term stability of vialed drug product.
  • Ensure that assigned processes are cGMP compliant and are designed to meet the regulations of the U.S FDA and the EMA.
  • Accountable to plan, organize, and execute experiments, along with presentation of study outcomes to the group and larger audiences
  • Maintain an up-to-date ELN with good documentation practices
  • Closely collaborate with multiple groups to generate innovative solutions to challenging formulation and process problems.


Here's What You'll Bring to the Table:
  • Education Qualifications - Masters or Bachelor's Degree in on one of the following fields: Chemical Engineering, Biochemical or Biomedical Engineering, or any related or sub-disciplines of the above.
  • Relevant Experience: Bachelor's degree with 0-5 years of experience or Master's Degree with 0-2 years of experience
  • Exceptional laboratory skills with ability to work efficiently and productively in a highly dynamic environment
  • Knowledge of statistical design of experiments (DoE) and analysis
  • Knowledge of nucleic acid chemistry and biology
  • Preferred: Experience in BioPharma, BioPharmaceutical, Pharmaceutical, or Biotechnology industry
  • Preferred: Experience with nanoparticle formulation technology
  • Preferred: 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/validation is a plus.
  • Preferred: Knowledge of GMP compliance.
  • Candidate will be curious in exploring new paths for drug development, bold in proposing creative experimental designs and ideas. Will work collaboratively with multifunctional teams and will be relentless in pursuing successful outcomes


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

At Moderna, we believe messenger RNA, or mRNA, is the "software of life." Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past four years. To learn more, visit www.modernatx.com .

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

#LI-AG1

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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