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Moderna · 19 hours ago

Senior Engineer II, Drug Product Development

Norwood, MA

Full-time

Onsite

Senior Level, Lead/Staff

$131K/yr - $209K/yr

8+ years exp

Moderna is a pioneering company revolutionizing medicine through mRNA technology, and they are seeking a Senior Engineer II for Drug Product Development. This role involves providing technical leadership for temperature-controlled shipping system validation, ensuring regulatory compliance, and collaborating with various teams to enhance the distribution of mRNA medicines.

BiotechnologyGeneticsHealth CareMedicalPharmaceuticalTherapeutics

Comp. & Benefits

No H1B

U.S. Citizen Only

Responsibilities

Serve as the technical lead and subject matter expert for shipping validation within Drug Product Development

Define and implement robust, risk-based validation strategies across temperature-controlled distribution systems

Design, qualify, and maintain global shipping systems supporting clinical and commercial product movement

Execute distribution and packaging studies including temperature mapping, ISO/ASTM testing, and thermal modeling

Lead lane qualification and lifecycle management activities across validated transport solutions

Drive strategic decision-making through risk assessments, data analysis, and regulatory compliance frameworks

Author, review, and approve technical documents including validation master plans, protocols, and SOPs

Support internal and external audits, including health authority inspections and responses

Lead investigations, CAPAs, and change controls related to shipping systems and temperature excursions

Collaborate with Quality, Regulatory, Supply Chain, and Engineering to align and execute shipping strategies for late-stage and commercial programs

Contribute to global regulatory submissions, including INDs, BLAs, and MAAs, by authoring distribution-related sections

Provide mentorship to junior engineers in validation strategy, technical documentation, and compliance standards

Advance platform-level initiatives by developing scalable validation approaches and contributing to organizational best practices

Qualification

Shipping validationTemperature-controlled distributionRisk-based validation strategiesBiopharmaceutical developmentRegulatory complianceData analysisTechnical documentationCollaborationMentorshipProblem-solving

Required

Degree in Chemical/Mechanical/Packaging/Biomedical Engineering, Pharmaceutical Sciences, or related discipline

Minimum of 4 years (PhD), 8 years (MS), 10 years (BS) industry experience in biopharmaceutical development, focused on shipping validation

Experience working closely with external CDMOs and service providers

Experience in shipping of parenteral Drug Products and commercialization of a range of relevant drug product images such as pre-filled syringes, injection devices and vials

Knowledge and understanding of product/packaging interaction, barrier properties, stability, global pharmaceutical shipping regulations, and distribution testing

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

Ability to travel up to 20%

This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work