ModernaTX, Inc. seeks an Engineer, Manufacturing Sciences & Technology for its Norwood, Massachusetts location.
Here's What You'll Do:
Lead the technology transfer of Small Molecules (SM) products and nucleotide production processes from development to GMP manufacturing.
Apply knowledge of unit operations, including Tangential Flow Filtration, Anion Exchange Chromatography, Small Molecule Synthesis Reaction, Inline Filtration, Bottling/Filling, Lipid Encapsulation, Mixing, Clean-in-Place (CIP) and Clean-out-of-Place (COP) to determine process, equipment, and quality control strategy requirements and perform facility fit assessments.
Develop User Requirement Specifications (URS's), Process Flow Diagrams (PFD's), and technology transfer documents, including process descriptions, bill of materials, bill of parameters, bill of equipment, study protocols, monitoring protocols, study reports, qualification summary reports, sensor risk assessments, standard operating procedures, and master batch records (step-by-step instructions to manufacture product batches).
Drive or support Failure Mode and Effects Analysis (FMEA), Failure Mode, Effects and Criticality Analysis (FMECA), Fault Tree Analysis (FTA), Hazard and Operability Analysis (HAZOP), and Alarm Rationalization assessment to quantify risk and recommend risk mitigation strategies.
Support Process Characterization with a Quality by Design approach to determine Design of Experiment (DoE) strategy tailored to each specific process and product.
Determine Critical Process Parameters, Proven Acceptable Range and Normal Operating Range, as well as Critical Quality Attributes.
Support incident investigations through Root Cause Analysis (RCA) and other TapRooT methodologies including Ishikawa diagrams, Scatterplots, and Pareto Charts.
Troubleshoot instruments such as Filter Integrity Testers, pH meter and probes, temperature control units, conductivity meter and probes, temperature meter and probes, sensor flowrate meters, single use mixers, chromatography skids, jacketed mixing glass reactors, peristaltic pumps, quaternary diaphragm pumps, biosafety cabinets and fume hoods.
Utilize quality documentation management tool (Veeva Vault QMS), laboratory database (LabVantage), equipment database (BlueMountain), and software such as OSI PI Historian, Spotfire, JMP, SAP, Microsoft Office (Excel, Visio, OneNote, PowerPoint, Word, etc) in performance of job duties.
Ensure operations are in compliance with all Regulatory, Environmental, Health and Safety (EH&S), and cGMP (current Good Manufacturing Practices) quality systems that assure proper design, monitoring, and control of manufacturing processes and facilities.
Author Biologics License Application (BLA) Filing documentation and support Regulatory/Health Agency audits.
Lead optimization activities and provide technical expertise for process improvements using DMAIC methodology (Define, Measure, Analyze, Improve and Control) and tools such as Process Mapping, Control Charts, and Pareto Charts.
Ensure high degree of performance consistency at the required quality standard.
Here's What You'll Bring to the Table:
Minimum requirements: Requires a Bachelor's degree in Chemical Engineering or related field and 4 years of progressive post-baccalaureate experience in the position offered or as Process Engineer, Equipment Engineer, Validation Engineer, or related position in the pharmaceutical or biotechnology industry. Alternatively, employer will accept a Master's degree in the stated fields and 2 years of experience in the stated occupations.
Must have 2 years of experience with:
Executing Technology Transfers, Process Scale-ups and Process Validations in a GMP environment;
Supporting Unit Operations, including Mixing, Filling and Filtration, Chromatography test methods and providing person-in-plant support to troubleshoot incidents;
Supporting health agency audits and authoring responses/reports to health agency inquiries;
Risk Assessments including FMEA, Failure Mode, FMECA, FTA, HAZOP, and Alarm Rationalization;
Incident Investigations, including RCA by using TapRooT methodology, Ishikawa diagrams, Scatterplots, and Pareto Charts; and
Data analysis with MiniTab and JMP.
May telecommute up to 2 days per week.
Up to 10% domestic and international travel required.
Apply at https://modernatx.wd1.myworkdayjobs.com/en-US/M_tx (Job ID: R17075) or email resume and cover letter to careers@modernatx.com with subject line: R17075.
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
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!
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer) #LI-NB1 -
