Manager, Operations-Department of Neurosurgery-GMP Lab

Manager, Operations-Department of Neurosurgery-GMP Lab Gainesville, FL Job Details Full-time $70,600 - $80,200 a year 1 day ago Qualifications Research design Manufacturing management Sourcing GLP Operations management Procedural guides Technical documentation Engineering Laboratory experiments Biotechnology Mid-level 3 years Master's degree Manufacturing standard operating procedures Bachelor's degree Production planning Quality control Batch records Virology Organizational skills Experimental design Quality standards in production Cleanroom Training & development Master's degree in engineering Mammalian cell culture Production scheduling Manufacturing company experience Overseeing training Engineering validation Master's degree in biotechnology

Full Job Description JOB NO:

539355

WORK TYPE:

Staff Full-Time

LOCATION

Main Campus (Gainesville, FL)

CATEGORIES

Biology/Life Science, Grant or Research Administration

DEPARTMENT

29190000 - MD-NEUROLOGICAL

SURGERY CLASSIFICATION TITLE

Manager, Operations

CLASSIFICATION MINIMUM REQUIREMENTS

Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.

JOB DESCRIPTION

Manage the Tech Transfer of new manufacturing processes. Coordinate the development of new quality control testing procedures with the Associate Director of Operations and individual project managers. Plan and direct the development of new manufacturing process in collaboration with the Director of Operations and project sponsors. This will involve the design and execution of required process development experiments and analysis of experimental results. This includes the evaluation of required new biological materials such as viral vectors, mammalian cell lines and associated material transfer requirements, health and safety precautions, and required storage and use conditions. This will also involve the drafting and implementation of required engineering design systems and associated specification technical documents Identify required manufacturing equipment. Coordinate the purchase, installation, and drafting of required validation protocols and Standard Operating Procedures (SOPs). This will include a comprehensive verification that new equipment engineering specifications comply with facility design parameters and other facility equipment Identify new raw materials required for new manufacturing processes, identify appropriate vendors for purchase, and draft required raw material specification documents according to current SOPs. Where needed, this will include the drafting and/or review of engineering design specifications for materials . Develop new custom bioprocess reagents as needed, including contracting with contract manufacturers for production and testing. Where needed, this will include the drafting and/or review of engineering design specifications for materials Works with the Process Development Group for the transfer of final process to GMP Manufacturing, including the drafting and issuance of production batch records according to current SOPs. Where needed, this will include the drafting and/or review of engineering design specifications for both process and associated equipment Oversight of Manufacturing Staff and of Manufacturing Operations. Oversee the training and daily job performance of all manufacturing personnel according to current SOPs Develop daily, weekly, monthly, and annual manufacturing schedules in coordination with the Director of

GMP EXPECTED SALARY

$70,600-$80,200 REQUIRED

QUALIFICATIONS

Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.

PREFERRED

EDUCATION & TRAINING Master's degree in a biotechnology/life science or in engineering, and at least four years of direct experience in a clean room environment with GMP involvement.

EXPERIENCE

3+ years of related experience in cell processing and Viral Vector Production

KNOWLEDGE

Working understanding of Gene and Cell Therapy concepts Experience with clean room work and GLP/GMP regulations, as well as mammalian cell culture and virology SKILLS Detail-oriented Strong organizational skills

PHYSICAL QUALIFICATIONS

Must be able to lift items weighing up to 50 pounds

SPECIAL INSTRUCTIONS TO APPLICANTS

For consideration, please complete an application and include a cover letter, resume and the names and email addresses of three to five references. The University of Florida is an Equal Employment Opportunity Employer. Application must be submitted by 11:55 p.m. (ET) of the posting end date.

HEALTH ASSESSMENT REQUIRED

Yes

ADVERTISED

01 Apr 2026 Eastern Daylight Time

APPLICATIONS CLOSE

08 Apr 2026 Eastern Daylight Time