- Management of complex DP investigations: Investigation management, Root cause analysis, Risk assessment, CAPA, Documentation and Reporting, Decision-Making, Problem solving, compliance monitoring
- Technical Drug Product Stewardship in support of clinical programs: Product technical strategy, engagement with technical development and manufacturing to identify solutions to complex technical challenges, product risk management, process benchmarking, technical support and troubleshooting, process development and optimization, innovation and product development
- New equipment and facility build out: Equipment installation and commissioning, Facility design and construction, Inspection systems installation and implementation, Labeling technology and machinery set up, Packaging line design and setup for clinical and commercial, Engineering design principles, technology transfer in support of insourcing and outsourcing
- Lead and manage complex technical investigations to address deviations, out-of-specification results, and other product-related issues.
- Serve as the technical lead for drug product teams, providing strategic direction and expertise in fill-finish, inspection, packaging, and labeling operations.
- Assume responsibility for product technical stewardship, ensuring that all aspects of drug product manufacturing are compliant with regulatory requirements and industry best practices.
- Develop and implement product technical strategies that align with the company's objectives and market demands.
- Collaborate with cross-functional teams, including R&D, Quality, Regulatory Affairs, and Operations, to ensure seamless technology transfer and scale-up of drug products.
- Drive continuous improvement initiatives to enhance process robustness, increase efficiency, and reduce costs while maintaining product quality.
- Provide technical input during regulatory submissions and respond to questions from health authorities.
- Author and review technical documentation, including validation protocols, standard operating procedures (SOPs), and technical reports.
- Mentor and develop junior MS&T staff, fostering a culture of technical excellence and knowledge sharing.
- Represent the MS&T department in strategic planning discussions and provide expert guidance on technical matters
- Experience in new facility build-outs and new equipment qualification is highly desirable, including involvement in design, commissioning, and validation activities to ensure operational readiness for drug product manufacturing.
- Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline.
- Minimum of 7 years of relevant experience in the biotechnology or pharmaceutical industry, with a focus on drug product manufacturing.
- Extensive experience managing complex technical investigations and providing technical leadership for drug products.
- Strong technical background in fill-finish, inspection, packaging, and labeling processes for pharmaceutical products.
- Demonstrated ability to develop and execute technical strategies for drug products.
- Excellent problem-solving skills with a systematic approach to root cause analysis.
- Familiarity with regulatory requirements and guidelines for pharmaceutical manufacturing (e.g., FDA, EMA, ICH).
- Strong leadership and communication skills, with the ability to influence and collaborate effectively with various stakeholders.
- Proficient in data analysis and interpretation, with a solid understanding of statistical methods.
- Product technical stewardship
- Experience in new facility build out
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
- 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
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Sr. Engineer I, Drug Product MS&T - Norwood, United States - Moderna
Description
The RoleIn this role, you will be a key technical leader in the organization, responsible for managing complex investigations, providing drug product technical leadership, and ensuring product technical stewardship. This role requires a strong understanding of the fill-finish process, inspection, packaging, and labeling of pharmaceutical products. The ideal candidate will have a proven track record in developing product technical strategies and leading cross-functional teams to maintain product quality, efficacy, and compliance throughout the product lifecycle. Experience in new facility build-outs and new equipment qualification is highly desirable, including involvement in design, commissioning, and validation activities to ensure operational readiness for drug product manufacturing. Specific skill sets/role will include:
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 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 (EEO/AAP Employer)
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