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Sr. Specialist, Manufacturing, Clinical Drug Product
4 months ago
The Role
The Manufacturing Operations Support team is responsible for the day-to-day operational support of clinical and commercial drug substance processing and release through batch record review and continuous improvement projects. A Sr. Technical Specialist, Manufacturing uses extensive knowledge of manufacturing practices, bioprocess unit operations, process engineering and digital systems to act as a technical leader for the clinical drug product manufacturing team. The Sr. Specialist will, independently and proficiently, lead in the development of operational procedures and training material, training manufacturing associates, supporting technology transfer activities, investigating issues that arise, and driving projects.
Here's What You'll Do
* Follow all relevant GMP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
* Practice and promotes safe work habits and adheres to safety procedures and guidelines. • Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
* Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
* Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence of gowning and vision, if applicable.
* Utilize the manufacturing support systems and equipment as required including, but not limited to, SAP, VEEVA, Delta V, Syncade, LIMS, CMMS.
* Provide on-the-floor coaching of the manufacturing team in execution of the process, troubleshooting, cGMPs and safety practices.
* Serve as the manufacturing lead for tech transfers and other projects.
* Leads cross-functional teams to drive complex manufacturing operation changes, improvements, and issue investigations.
* Work with process SMEs to develop batch records, SOPs, and training materials.
* Closely partner with QA colleagues for disposition of batches, including ensuring timely batch record, protocol, and log reviews, deviation investigation support.
* Support the investigation and own CAPA implementation for manufacturing deviations.
* Own and manage change controls for projects within the team.
* Own the purchasing and induction of simple equipment and tools.
* Participate in equipment start-up, commissioning, and validation activities.
* Approve SOPs and batch records, change controls, technology transfers, and protocols as delegated.
* Additional duties as may be assigned from time to time
* No delegation authority associated with this role.
Here's What You'll Need (Minimum Qualifications)
Required Background:
* Education: Degree
* Experience: STEM degree with 5-8 years' industry experience or a Masters' degree with 3-5 years' industry experience
* Specific Certifications or Training: None
Here's What You'll Bring to the Table (Preferred Qualifications)
* Other Quantifiable Preference: 2 years' experience with batch record review or a similar technical writing system in a cGMP environment. Comprehensive understanding of GMP regulations.
* A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
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)
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