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1+ months

Senior Manager, Bioassay

Kelly Services
Alachua, FL 32616
**Kelly is actively recruiting for Direct Hire Sr. Manager BioAssay for a Biologics company in the Greater Gainesville area, FL.**


The Sr Manager, Bioassay, reports to the Director, Quality Control, and will be responsible for all CGMP related bioassay method transfer, qualification, characterization, release and stability testing for monoclonal antibody products, viral vaccines, gene therapy products, virus-like particle products as well as other therapeutic biopharmaceuticals. In addition, the Sr Manager, Bioassay will be responsible for:

Providing management of personnel in the Bioassay team.

Planning and directing the day to day activities of the technical staff, including verification of completed, signed analytical reports, relevant SOPs, instrument qualifications and other activities as deemed necessary.

Operating robust CGMP bioassay analytical testing for biologic products under CGMP criteria.

Leading method transfer, qualification and validation for complex bioassay methods to include cell based bioassays, ELISAs, flow cytometry, qPCR, ddPCR, CE and other applicable methods as deemed necessary.

Interfacing with the Director, Quality Control to ensure CGMP compliance and documentation.

Interfacing with Quality Assurance, Supply Chain, Manufacturing, Process Development, Validation, Engineering and other operations related functions.

Interfacing with clients in regular Integrated Product Team meetings.


*All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.


Minimum Education and Experience Requirements for Competency:

MS in a Biological Science, (Biochemistry, Immunology, Molecular Biology, Virology), or related field with a minimum of 12 years related experience.

Minimum eight years of experience in CMC CGMP bioassay activities.

Minimum five years of management experience.

Strong analytical problem-solving and troubleshooting skills.

Strong leadership and communication skills.


**If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life.**


\#TJP2022_SPEC


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-04-11 Expires: 2022-06-11

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Senior Manager, Bioassay

Kelly Services
Alachua, FL 32616

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