Scientist, Process Development

HERE’S WHAT YOU’LL BRING TO THE TABLE:

PhD with 0-2 years, MS with a minimum of 5 years or BS with a minimum of 8 years of industry experience in the biopharmaceutical/biotechnology space. Pharmaceutical Sciences, Chemical Engineering or related Scientific field preferred.
Prior experience with drug products based on nanoparticle delivery technology is preferred.
Demonstrated background of providing technical support to commercial manufacturing processes, including but not limited to, support of process investigations, implementation of pro-active process modifications and support of post-approval changes.
Experience with mature quality management systems, deviation management, change controls and CAPA implementation.
Hands-on experience with aseptic liquid filling of vials. Familiar with current varieties and suppliers of parenteral vials and stoppers.
Hands-on experience with best current practices and trends in disposable sterile technologies.
Experience with process scale-up/scale-down and technology transfer of FDA-regulated manufacturing processes.
Working knowledge of relevant FDA, EU, ICH guidelines and regulations.
Knowledge of GMP regulations, Process Validation/Qualification principles, and aseptic processing principles.
Hands-on experience with sterile filtration unit operations and a variety of filter membranes and manufacturers. Experience working with filter manufacturers on the design filter validation studies is a plus.
Preferred: Hands-on experience with aseptic lyophilization and aseptic filling of pre-filled syringes
Preferred: Fluent in PDA Technical Reports 22, 26, 60, and 79.
Creative/innovative/problem solver.
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

THE ROLE:

Moderna is working to develop first-in-class messenger RNA (mRNA) based medicines. Moderna is seeking a highly skilled and motivated Scientist with a strong background in Drug Product (DP) development in the biopharmaceutical/biotechnology space residing in Moderna’s Technical Development organization in Norwood, MA. This role is part of the Commercial Development and Readiness team and enables commercial and clinical supply for Moderna’s seasonal vaccines, individualized neoantigen therapies, and future products. The applicant should have strong communication and collaboration skills, along with multiple examples of a strong technical background in Drug Product Development.
The successful candidate should have strong experience in aseptic processing, tech transfer, visual inspection, and fill/finish Process Development. Ideal candidates should have prior demonstrated experience in supporting clinical/commercial drug product operations with a focus on pro-active process improvements and optimization, effective troubleshooting, interfacing with existing teams to collaboratively resolve process investigations and implement appropriate controls to ensure robust clinical/commercial manufacturing at internal/external manufacturing facilities. We seek applicants that are proactive, enthusiastic, and show a passion for their work. Applicants should have prior project leadership experience, communications skills with a track record of excellent written and oral communication skills and experience operating within a Quality Management System. The position will support cross-functional teams across Analytical Development, Manufacturing Sciences and Technology, Manufacturing, Supply Chain, Quality, Regulatory and Program Management functions as well as with external CMO teams.
In this role, multi-day domestic and/or international travel (up to 20%) should be expected to support process investigations, technology transfer and provide Person-in-Plant (PiP) support for clinical/commercial batches.

HERE’S WHAT YOU’LL DO:

Provide subject matter expert (SME) expertise and representation in cross-functional process investigations for clinical/commercial drug product.
Support processes related to fill/finish packaging, labeling, and logistical support for clinical trial products, as well as large scale manufacturing.
Support process investigations by active participation in root cause assessment exercises utilizing standard-industry tools.
Design and execute detailed experiments using appropriate scale down models, QbD principles and process characterization/modeling techniques to assess and confirm root causes of process deviations and identify effective mitigation tools.
Cross-functionally support establishment of appropriate CAPAs needed to improve robustness of clinical/commercial manufacturing of Moderna’s drug product.
Identify opportunities for pro-active process improvements and optimization based on commercial performance data to improve robustness of commercial manufacturing process.
Interface extensively in a matrixed environment with Process Development teams for process investigation support, assess new technologies, support on-going process characterization and post-approval changes.
Develop protocols to evaluate the compatibility of the drug product with processing materials, container closure components, and sterilization processes.
Support development of processes suitable to ensure long-term stability of bulk and vialed drug product.
Provide subject matter expertise on complex aseptic liquid and lyophilization filling applications. Equipment includes state-of-the-art, highly automated systems, as well as traditional, legacy systems.
Support technology transfer of drug product processes, both internally and to external CMOs. Serve as person-in-plant, where applicable.
Support scale-up/scale-down of drug product manufacturing (e.g. Fill/finish, Freeze/thaw, Lyophilization).
Serve as subject matter expert on particulate control and visual inspection processes across Moderna’s fill/finish operations.
Ensure that assigned processes are cGMP compliant and are designed to meet the regulations of the U.S FDA and the EMEA.
Other responsibilities as assigned.