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Sr. Manager, Validation, Drug Product

Employer
Moderna, Inc.
Location
Norwood, MA
Start date
Jun 13, 2024

Job Details

The Role

Reporting to the Associate Director, Validation the Sr. Manager, Validation is responsible for leading Validation readiness for a state-of-the-art Drug Product (Fill Finish) cGMP manufacturing facility. This role involves ensuring operational readiness for production of both clinical and commercial drug products while adhering to current GxP, corporate, regulatory and industry best practices.The role is responsible for providing cross functional support for Commissioning, Qualification & Validation (CQV) activities which occur as part of the facility start up.

The objective of this role includes the development and execution of a comprehensive validation strategy including regulatory inspection readiness. The leader will liaise with key stakeholders to work through the facility integration strategy in addition to ensuring the appropriate systems and operational processes are developed, implemented, and maintained to ensure the seamless start-up and routine operation of the facility.

Upon facility start-up this role will provide end-to-end Validation oversight for drug product operations to ensure compliance with cGMPs, company procedures, and regulatory requirements.

The Sr. Manager will play a crucial role in establishing the operational strategy, implementing best practices, and building a team to achieve excellence in manufacturing operations while adhering to regulatory compliance and quality standards. You will be at the forefront of our mission to deliver mRNA therapies to patients worldwide, using your expertise to ensure the smooth operation of our manufacturing processes. Your work will directly contribute to the production of therapies that have the potential to transform the lives of patients.

Heres What Youll Do

In this role, your responsibilities will include:

  • Supervise and lead Validation Engineers (FTEs and/or Contractors) responsible for the commissioning, qualification, and validation of facilities, utilities, equipment, and critical processes for Drug Product Manufacturing at Modernas Norwood MTC Campus.

  • Develop and execute validation plans for facility utilities, equipment, and processes, including formulation, clean component preparation, filling, visual inspection, and packaging.

  • Prepare and review validation documentation, including protocols, reports, and Standard Operating Procedures (SOPs).

  • Coordinate and perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.

  • Serve as Validation System Owner for validation systems and hardware. Develop and improve maintenance strategies for validation hardware.

  • Work closely with cross-functional teams to ensure compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and industry standards.

  • Investigate and troubleshoot validation-related issues and implement corrective and preventive actions (CAPA). Ensures timely resolution of documentation, compliance, product complaints, and quality deviation investigations.

  • Maintain validation status of systems and equipment through periodic reviews and revalidation activities.

  • Support risk assessments and change control processes related to facilities and engineering.

  • Provide technical expertise and training to other team members and departments on validation principles and practices.

  • Collaborate with project teams on the integration of new technologies and equipment into the production environment.

  • Ensure timely completion of validation activities in line with project timelines and production schedules.

  • Own quality records or actions within quality systems (i.e. Change Controls, Deviations, and CAPAs) related to validation activities. Provide input into assessing change controls, and continuous improvement initiatives.

Heres What Youll Need (Minimum Qualifications)

  • Bachelor of Science degree in Engineering, Pharmaceutical Sciences, or a related technology discipline.

  • A minimum of 8 years of experience with at least 2 years in drug product manufacturing.

  • In-depth knowledge of cGMP, FDA, and regulations, pharmaceutical processing, and cleanroom operations.

  • Experience with validation of utilities, formulation, filling, visual inspection, and packaging systems.

  • Excellent written and verbal communication skills, with the ability to prepare clear and concise validation documentation.

  • Strong problem-solving abilities and attention to detail.

  • Ability to work independently and as part of a team in a fast-paced and changing environment.

  • Proficient in Microsoft Office Suite and validation management software.

  • Strong leadership skills with the ability to develop and motivate a diverse team.

  • Excellent project management, organizational, and communication skills.

  • Demonstrated ability to work cross-functionally and manage complex projects with multiple stakeholders.

  • Problem-solving mindset with a commitment to quality and safety.

Heres What Youll Bring to the Table (Preferred Qualifications)

  • Proven track record of successful facility start-ups or major operational projects within the pharmaceutical industry.

  • Excellent project management, organizational, and communication skills.

  • Demonstrated ability to work cross-functionally and manage complex projects with multiple stakeholders, with the ability to convey complex information in an understandable manner to various stakeholders.

  • A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

  • 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)

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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

 

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Company info
Website
Phone
617-714-6500
Location
200 Technology Square
Cambridge, MA
US

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