Address
Form of workThe Role
In this role, you will be responsible for the development, implementation, and optimization of inspection, packaging, and Labeling processes to support clinical and commercial production at a new state-of-the-art Drug Product (Fill Finish) cGMP manufacturing facility. This is a unique opportunity to spearhead and shape the future of inspection and L&P workflows at the new facility located in Norwood. This role will serve as a subject matter expert on inspection, packaging, and Labeling in support of clinical and commercial drug products in vials and pre-filled syringes presentation for liquid and lyo dosage forms.
Heres What Youll Do
Develop and optimize Knapp kits for use in manual and automated inspection processes.
Design and implement robust inspection and packaging procedures to ensure product quality and compliance with regulatory requirements.
Develop recipes and parameters for automated visual inspection systems, ensuring high accuracy and efficiency.
Set up, qualify, and maintain inspection and Labeling equipment, including troubleshooting, and performing routine maintenance.
Develop and maintain expertise in serialization technologies and requirements for the purpose of product traceability and anti-counterfeiting.
Collaborate with IT and production teams to integrate serialization systems with existing manufacturing and packaging equipment.
Oversee the generation, management, and exchange of serialization data with internal systems and external partners such as contract manufacturers and distributors.
Experience with new facility build out is highly desirable.
Collaborate with cross-functional teams to integrate inspection and Labeling processes into the overall manufacturing workflow.
Conduct risk assessments and root cause analyses for inspection and packaging operations.
Create and maintain accurate documentation, including SOPs, batch records, and equipment logs.
Train personnel on inspection and Labeling procedures and equipment operation.
Stay current with industry trends and advancements in inspection technology and regulatory guidelines.
Participate in audits and inspections by regulatory agencies and internal quality assurance teams.
Collaborate with the engineering and quality teams to identify and implement process improvements.
Additional duties as may be assigned from time to time.
Heres What Youll Need (Basic Qualifications)
Bachelors or Masters degree in Engineering, Life Sciences, or related field.
Minimum of 3 years of experience in an MS&T or related role within the pharmaceutical or biotechnology industry.
Heres What Youll Bring to the Table (Preferred Qualifications)
Proven expertise in Knapp kit development for inspection processes.
Strong knowledge of manual, semi-automated, and automated visual inspection systems.
Experience in recipe development for automated visual inspection equipment.
Proficiency in setting up and qualifying inspection and Labeling equipment.
Familiarity with cGMP regulations and other relevant industry standards.
Excellent troubleshooting, analytical, and problem-solving skills.
Strong communication and interpersonal skills, with the ability to work effectively in a team environment.
Detail-oriented with strong organizational skills and the ability to manage multiple tasks simultaneously.
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Physical Requirement: Ability to work in a manufacturing environment, including standing for extended periods and handling of production equipment.
This position is site-based, requiring you to be at Modernas site full-time. This position is not eligible for remote work.
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, theinfrastructure 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 peopleare 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. 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 contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
-
