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Manager, Production Operations - GMP

Jupiter, FL USA

Who we are: 

Maravai LifeSciences translates extraordinary science into everyday miracles, helping biotech, biopharma, and life sciences companies everywhere deliver novel vaccines, therapeutics, and diagnostics. We are global leaders in providing products and services within the fields of nucleic acid production and biologics safety testing to many of the world's leading biopharma, vaccine, diagnostics, and cell and gene therapy companies.  

At Maravai, we believe that diverse perspectives are the foundation of innovation. Through an inclusive and equitable culture where every team member is inspired to bring their best selves to work, we cultivate an environment in which we can lead together, providing differentiated value to our customers, and enabling the miracles of science. For over 35 years, Maravai’s portfolio companies have served as a catalyst for innovative, lifesaving technology for humanity. Pioneering nucleotide research since its inception, we are now leading the way in the rapidly expanding mRNA market. 

Your next role as a Miracle Maker 

Maravai LifeSciences is seeking a GMP Manufacturing & Support Manager to join our Operations team at Alpha-zyme. In this critical role, you will play a key part in establishing and enhancing our GMP facility and capabilities, ensuring compliance with industry regulations, and leading a high-performing team to support GMP-grade manufacturing operations.

At Alpha- zyme, we are committed to delivering high-quality, custom enzyme solutions that power scientific discovery and innovation. As a GMP Manufacturing & Support Manager, you will be instrumental in building and optimizing our GMP infrastructure, ensuring that our processes meet the highest industry standards while supporting our mission to enable scientific breakthroughs through the reliable supply of specialized enzymes.

How you will make an impact: 

  • Lead efforts to bring up and expand GMP facility capabilities, ensuring adherence to industry regulations and best practices.
  • Train, schedule, and supervise production and manufacturing support staff to ensure operational efficiency and compliance.
  • Conduct investigations into GMP production issues and manage non-conformance events.
  • Oversee GMP cleaning operations and provide technical support to meet production schedules.
  • Ensure GMP production processes meet all regulatory standards and company requirements.
  • Review and approve controlled documents, cleaning documentation, and executed batch records.
  • Lead or support activities related to CAPAs, change control, and QMS items.
  • Collaborate with cross-functional teams, including Manufacturing, Facilities, Engineering, Supply Chain, and Process Development, to address support needs.
  • Hire and develop operators, maintaining training matrices and job descriptions to ensure workforce readiness.
  • Support activities related to ISO 14644 cleanroom classifications and compliance.
  • Drive continuous improvement initiatives to enhance production processes and maintain compliance.

 The skills and experience that you will bring: 

  • Bachelor’s degree in life sciences or engineering with a minimum of 4 years of relevant experience in the pharmaceutical or related industry (Master’s degree preferred).
  • At least 2 years of experience managing, supervising, and developing teams in a GMP setting.
  • Strong knowledge of cGMPs, including experience drafting GMP documents (Deviations, NCMRs, CAPAs, SCARs, SOPs, Batch Records, Validations, and Forms).
  • Familiarity with 21 CFR 210/211 quality systems and cGMP production processes.
  • Experience with biologics manufacturing or CDMO environments is preferred.
  • Proficiency in electronic quality systems for cGMP facilities.
  • Understanding of ISO 14644 cleanroom classifications and cleanroom compliance.
  • Proven ability to implement processes that drive measurable improvements in manufacturing operations.
  • Strong written and verbal communication skills, with the ability to collaborate cross-functionally and drive initiatives forward.

#LI-ONSITE

The benefits of being a #MiracleMaker: 

  • You have the potential to change, improve, and save lives around the world. 
  • You have the opportunity to be a part owner in Maravai through RSU grants and optional employee stock purchase plans. 
  • We offer comprehensive medical plans and HSA/FSA options. 
  • Fertility & family planning assistance. 
  • A variety of additional optional benefits and insurance options, including pet insurance. 
  • Retirement contributions. 
  • Holidays & Paid Time Off. 

Benefits may vary by region and employment type and do not apply to temporary employees or contractors. See a comprehensive list of benefits at our Benefits & growth site at https://www.maravai.com/careers/benefits-and-growth/ 

To view more opportunities to become a #MiracleMaker, visit our career site at https://www.maravai.com/careers/  

Maravai LifeSciences is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation, and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law. 

Click here to view Maravai LifeSciences Privacy Notice 

 

HIRING SCAM ALERT 

Recently, individuals impersonating Maravai LifeSciences Human Resources members have offered fraudulent interviews and job offers to unsuspecting candidates. To help protect you from these scam artists, please be aware that: 

  • Maravai LifeSciences will never interview a candidate over RingCentral, similar messaging apps or social media (e.g. Telegram, Google Hangouts, WhatsApp, Facebook Messenger, etc.) 
  • Maravai LifeSciences will never send a company check or ask an applicant to pay a fee or purchase at home work/training materials in connection with an application for employment. 
  • Maravai LifeSciences will never provide excess money to an applicant and ask the applicant to write a check for repayment. 

 

 If you have any doubt about a job offer or any other communication purporting to come from Maravai LifeSciences, please reach out to us directly at taops@maravai.com. If you believe you have been a victim of fraud, you can report this activity at: www.iC3.gov or www.stopfraud.gov. 

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