122 applicants
Moderna · 3 days ago
Scientist, Process Development
Norwood, MA
Full-time
Onsite
Senior Level
5+ years exp
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Responsibilities
Provide subject matter expertise in cross-functional process investigations for clinical/commercial drug product.
Support fill/finish packaging, labeling, and logistical processes for clinical trial products and large-scale manufacturing.
Design and execute experiments to assess root causes of process deviations and identify mitigation tools.
Support establishment of CAPAs for process improvements and optimization.
Interface with various teams for process investigation support, technology assessment, and process changes.
Develop protocols to evaluate drug product compatibility with processing materials and sterilization processes.
Support technology transfer of drug product processes internally and externally.
Ensure processes are cGMP compliant and meet regulatory requirements.
Other responsibilities as assigned.
Qualification
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Required
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
Fluent in PDA Technical Reports 22, 26, 60, and 79.
Benefits
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 year-end shutdown, 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!
Company
Moderna
Moderna Therapeutics is a biotechnology company that specializes in drug discovery and drug development based on messenger RNA.
1,001-5,000 employees
H1B Sponsorship
Moderna has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (51)
2022 (25)
2021 (51)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$3.73BKey Investors
Blackstone Life SciencesMSD CapitalBiomedical Advanced Research and Development Authority (BARDA)
2024-03-27Post Ipo Equity· $750M
2022-10-12Post Ipo Equity· $250M
2020-07-26Grant· $472M
Leadership Team
Stephane Bancel
President and Founding CEO
Kenneth Chien
Co-Founder
Recent News
The Motley Fool
2024-06-03
The Motley Fool
2024-06-03
Business Journals
2024-06-03
Company data provided by crunchbase
