Sr. Technical Specialist, New Product Introduction
- Employer
- Moderna, Inc.
- Location
- Norwood, MA
- Start date
- May 28, 2023
View more
- Discipline
- Clinical, Clinical Medicine, Marketing
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Genetown, Best Places to Work
Job Details
The Role:
Moderna is seeking a Sr. Specialist for the New Product Introduction team within Clinical Drug Substance. This role will be based at the Norwood, MA site. As a leader of NPI, he/she will apply expert knowledge of manufacturing practices, bioprocess unit operations and cGMPs to enable success with new product and process introductions while maintaining safety and compliance at the forefront. The NPI Lead will be a key player in the development of operational procedures, leading tech transfer activities, process improvements and driving right first-time results for new suites, equipment, and processes. This individual will lead operational introduction of new DS processes into MTC-S. This specialist will support deployment of the overall drug substance technical strategic roadmap.
Heres What Youll Do:
Lead and project manage process and equipment technical transfers from development and technology partners
Participate and lead cross-functional teams to drive complex manufacturing operational changes, improvements to existing processes and new product introductions
Drive operational readiness activities for new processes and products with water runs, right first-time preparation, introduction to manufacturing presentations
Practice and promote safe work habits- adhere to all safety procedures and guidelines
Provide on-the-floor support to the manufacturing team in execution of new processes, equipment, troubleshooting issues, and safety practices
Own and manage change controls for projects within the team
Participate in equipment start-up, commissioning, and validation activities as required
Creates and manages results of improvement projects, right first-time activities and batch completion reviews
Maintain a flexible schedule based on the demands of production and projects
Leverage Lean and Six Sigma principles to foster and drive a culture of continuous improvement
Heres What Youll Bring to the Table:
A BS in engineering or sciences and minimum of 3-5 years of highly relevant experience in manufacturing processes in a pharmaceutical or biotechnology environment.
A self-driven mindset who can work independently and as a team with minimal supervision and direction
Demonstrated track record of complex problem solving and troubleshooting technical and process related issues
Experience with MES, SAP and VEEVA highly preferred
Highly organized with proven project management skills
Demonstrated ability to lead, communicate and present data
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
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
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. Were 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 make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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Company
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.
mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”
Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.
Stock Symbol:
MRNA
Stock Exchange:
USNASDAQ GS
- Website
- https://modernatx.com/
- Phone
- 617-714-6500
- Location
-
200 Technology Square
Cambridge, MA
United States
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