Manager, Quality Control - Microbiology

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 #MiracleMaker to join our Quality Control team as a Manager, Quality Control - Microbiology .

As a Manager, Quality Control - Microbiology you will be charged with leading quality control activities, specifically in supporting the technical needs in the Quality Control Microbiological Department under cGMP CFRs and ISO guidelines.

The role will work closely with Manufacturing, Quality, Facilities, Engineering, and Process Engineering groups to monitor the TriLink cleanroom facilities and contamination control.

How you will make an impact :

• Establish and manage processes for routine Quality Control microbiological release testing and facility management and defense of Quarterly Reports and related Investigations.
• Work with colleagues and external contractors to coordinate effective Environmental Monitoring sampling and testing of Grade A-D including Aseptic Fills (Vials and Bags), ISO 8, ISO 7, and ISO 5 manufacturing areas, including air viable and nonviable and utility systems.
• Responsibilities include assisting with designing and conducting sampling studies, contributing to the review of summary reports and providing technical support on any follow-up actions.

The successful candidate will thrive in a flexible fast-paced environment and have experience working with Quality Management Systems.

• Review contractor reports, training, oversite and design follow-up action plans as needed
• Manage the implementation of microbiological methods in the Quality Control Microbiological Department to support business growth.
• Propose new capital or resource investments to allow QC to keep up with the overall growth of the business
• Mentor a growing team in best practices in microbiological methods and science, under GMP and / or ISO considerations
• Author / review of technical protocols and reports to support methods qualification / validation.
• Oversee the IOQ / PQ of analytical instrumentation and ensure successful Onboarding into GMP Systems
• Assist Department Head with budget and allocating resources per company objectives
• Perform other functions and duties as required

The skills and experience that you will bring :

• BS or higher in microbiology or related field
• 7+ years of relevant life science industry experience
• 3+ years experience with demonstrated skills in GMP and / or ISO, leading small teams of QC associates and / or scientists
• Experience in microbiological assays such as Endotoxin, Bioburden, TOC, and Conductivity.
• Experience in Environmental monitoring and utilities programs.
• Experience with managing multiple laboratories across different sites.
• Experience with method transfer of microbiological assays preferred.
• Experience with method, spreadsheet, and software qualification and validation preferred
• Experience with equipment / enterprise system integrations such as LIMS integrations with laboratory equipment preferred
• Proficient in MS Office applications, such as Word, Excel, and Project
• Experience with 21 CFR 820, 21 CFR 210 / 211, ICH Q7, ISO 9001, ISO 17025, and / or ISO 13485 requirements strongly preferred
• Strong multitasking abilities to complete activities in a fast paced, deadline driven environment
• Results driven self-starter
• Ability to manage stress and balance competing demands in a high throughput environment

The anticipated salary range for this position is $112,000 - $133,000. In addition, highly competitive long-term incentives in the form of company equity, bonus participation and company sponsored benefits are provided as part of the total compensation package.

The salary offer will depend on multiple factors which may include the successful candidate's skills, experience and other qualifications, as well as the location of the role.

The benefits of being a #Mirac le Maker :

• You have the potential to change, improve , and save lives around the world.
• You have the opportunity to be a part o wner in Maravai through RSU grants and optional employee stock purchase plans .
• We offer comprehensive medical plans and H SA / FSA options .
• Fertility & family planning assistance .
• A variety of additional optional benefit s 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.

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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 .