Position Summary & Role (general description of the role; e.g. expectations, key milestones, impact)
Work hours are 8 hours per day, Tuesday through Saturday. However, depending on production activities, although rare, overtime in the evening and/or weekends and holidays work may occur - predominantly in the manufacturing core in classified cleanroom environment. May also be required to work at times in a range of environments including regular laboratories areas. Work environment also includes office space for administrative work, document preparation/review and access to electronic Operation and Quality Systems.
Job Responsibilities (core responsibilities; include people management if applicable)
- This position will perform and lead production related activities in the cGMP Manufacturing Core according to established procedures at the Medical Counter Measures (MCMs) Advanced Development and Manufacturing Facility in Alachua (Florida).
- Lead upstream related activities including cell culture at small and large scale, cell transfection, media and buffer preparation, and bioreactor and fermenter-based production.
- Lead upstream related activities including incubators, wave reactors, single-use bioreactors, depth filtration skids, TFF skids, centrifugation and ultracentrifugation single-use mixers, in process testing equipment , , and viral clearance.
- Establishes performance standards and goals for manufacturing associates.
- Draft Standard Operation Procedures, Change Controls, and Deviations.
- Draft and review Production batch records and review executed records.
- Order equipment and perform installation, qualification, and routine maintenance.
- Resolves problems of manufacturing staff and manages manufacturing resources
- Prepares and conducts technical presentations of manufacturing processes
- Works with subject matter experts to trouble-shoot and/or optimize processes as required
- Supports the technical transfer of new products into the manufacturing area
- Supports Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment
- Supports Ology QA during audits and regulatory inspections
- Supports other manufacturing process teams and other Ology groups as necessary to achieve Manufacturing team goals
- Approve timecards, personal time off requests, and coordinate scheduling of direct reports for on-time delivery of manufactured products.
- Conduct mid-year and end of year employee reviews for direct reports.
- Create and guide direct reports using Performance Improvement Plans, if necessary.
- Hirers, evaluates, train develop, and terminate staff.
- Adhere to safe working practices.
- Provide other assistance as needed to upper Management.
Preferred Experience, Education & Qualifications (Education/Degrees/Certifications)
- Minimum of a high school diploma or GED and 8 years of relevant work experience. A post-secondary degree from an accredited institution with a major field of study in Biology, Chemistry, Engineering or similar may substitute for the required experience (for example, an A.S and 6 years of experience, B.S. and 4 years of experience, M.S. and 2 years of experience).
- 2 years of team leadership responsibilities preferably in a cGMP environment.
- Ability to document work clearly and accurately and be detail oriented.
- Must have basic computer skills and familiar with Word and Excel.
- English reading comprehension and legible writing skills.
- Communication and organization skills in a teamwork environment.
- Experience working as a team member with shared responsibilities is desired.
- Previous work experience in GMP environment is preferred.
- Self-motivated and hard working
Other Ideal Personal Characteristics:
This job requires the employee to perform the following physical activities:
- Repetitive motion
This job requires the employee to work in the following conditions:
- Working while gowned for extended periods of time (4 hours before changing gown).
This job requires exposure to the following:
- Noise (enough noise to cause the employee to shout to be heard above ambient noise level.)
- Hazards: moving mechanical parts, electrical current, working on high places, exposure to high heat or exposure to chemicals).
- Hazards: packaging, shipping, handling, or decontamination of blood or other potentially infectious materials (OPIM), including continuous human cell lines.
- Hazards: packaging, shipping, handling, or decontamination of infectious agents assigned to risk group 2, including for emergency response.
- Hazards: packaging, shipping, handling, or decontamination of infectious agents assigned to risk group 3, including for emergency response.
- Laboratories, production rooms, waste holding areas, or other facilities where infectious agents are or may be handled or stored.
- Close quarters and small enclosed rooms.
- Conditions that affect the respiratory system or the skin: fumes, odors, dust, mists, gases, or poor ventilation.
- Narrow aisles or passageways.
This job requires the employee to perform the following type of physical work:
- Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
- Light work. Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the employee sits most of the time, the job is rated for light work.
This job requires the following visual acuity requirements:
- Preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.
- Determines the accuracy, neatness, and thoroughness of the work assigned or to make general observations of facilities or structures.
This job requires routine or periodic use of respiratory protection:
- Loose-fitting respirators, such as hood or helmet style Personal Air Purifying Respirators (PAPR).