Manufacturing Supervisor

5 days ago

Oxford, Oxfordshire, United Kingdom Moderna Therapeutics Full time
Manufacturing Supervisor, Drug Substance, Night Shift

We are seeking a highly skilled and experienced Manufacturing Supervisor to join our team at Moderna Therapeutics.

The Role:

As a Manufacturing Supervisor, you will be responsible for managing production timelines, ensuring compliance with cGMP regulations, and overseeing health and safety protocols. You will work closely with the Day Shift team to foster a collaborative environment and develop batch records, SOPs, and training materials for commercial programs.

Key Responsibilities:

  1. Enforce safety procedures and Moderna's guidelines to ensure compliance with local HSE requirements.
  2. Develop and maintain relationships with the Day Shift team to promote a collaborative work environment.
  3. Coordinate with the Quality Assurance team to ensure timely disposition of commercial batches.
  4. Manage documentation processes and oversee training and development of staff.
  5. Monitor and improve team performance, including regular one-on-one sessions.
  6. Collaborate with Supply Chain to maintain inventory and review process orders.
  7. Respond to routine equipment, process, and digital issues to ensure continuous operation.

Long-term Objectives:

  1. Lead projects aimed at continuous improvement, aligning operations with corporate goals and commercial demand.
  2. Drive initiatives to maintain manufacturing excellence.
  3. Ensure team performance monitoring and make necessary adjustments for improvement.
  4. Lead in troubleshooting and optimizing manufacturing processes.

Requirements:

  1. Typically, 5-7+ years of experience in a GMP manufacturing environment.
  2. A Bachelor's Degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical engineering, Biochemistry or related field preferred.
  3. Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP.
  4. Demonstrated commitment to Moderna's values of Bold, Collaborative, Curious, and Relentless, embodying these values in the workplace.
  5. Ability to collaborate fluidly with peers, supervisors, and cross-functional support groups required.
  6. Exceptional written, oral communication, and organizational skills required.
  7. Skills in project management, including planning, execution, monitoring, and closing projects.
  8. Experience with chromatography and tangential flow filtration would be an asset.
  9. Experience in audit/inspection preparation, understanding Health authority and regulatory guidelines.
  10. Knowledge of environmental monitoring practices in a cleanroom or controlled manufacturing environment.
  11. Specific expertise in mRNA technology, vaccine production, and equipment - beyond a general scientific understanding.
  12. Understanding/Detailed knowledge of regulatory requirements specific to mRNA drug products and vaccine production.
  13. Expertise in quality control measures and assurance processes specific to pharmaceutical manufacturing.
  14. Knowledge of validation processes for manufacturing equipment and processes.
  15. Ability to analyze production data and generate reports for management.
  16. Specific methodologies for continuous improvement, such as Lean, Six Sigma, or others.
  17. Experience in leading Kaizen events or other process optimization initiatives.
  18. Experience in coordinating with supply chain for raw materials and inventory management.

What We Offer:

  1. Quality healthcare and insurance benefits.
  2. Lifestyle Spending Accounts to create your own pathway to well-being.
  3. Free premium access to fitness, nutrition, and mindfulness classes.
  4. Family planning and adoption benefits.
  5. Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown.
  6. Educational resources.
  7. Savings and investments.
  8. Location-specific perks and extras.

About Moderna Therapeutics:

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 UK. We are 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.

We are an E-Verify Employer in the United States and 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.

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