Summary: The primary job responsibilities are planning, preparing and oversight of media/buffer prep scheduling according to strict quality standards and providing exceptional customer service. Train and develop Tech I, II, and III’s to work with minimal supervision with all media/buffer prep processes. Operate processing equipment including autoclaves and pressurized tanks per procedure and report any issues. Work effectively and efficiently in a team-oriented environment to keep Media Prep operations running smoothly. Interact with customers, vendors, suppliers, and internal departments to improve safety, maintenance, efficiency, and productivity. Report any training or policy deficiencies and identify opportunities to improve procedures and operations. Develop, implement, maintain and evaluate department SOPs, quality compliance GMPs, GXPs, GLPs, and other established procedures. Identify and support continuous improvement to processes as to increase customer satisfaction.
- Oversee Media Prep functions.
- Direct Media Prep Technicians on day-to-day activities.
- Provide input and support Manufacturing to meet production demands.
- Perform all job functions safely. Follow safety guidelines, equipment procedures, and chemical handling guidelines. Report any safety deficiencies or safety incidents immediately.
- Develop a thorough understanding of department procedures, quality requirements, performance metrics, and customer requirements.
- Gain a thorough understanding of the department and how Buffer Prep work impacts customers.
- Perform all operations free of operational variances and work with a high degree of precision and accuracy.
- Accurately prepare media per recipe or customer guidelines following established procedures (SOPs, GMPs, GLPs, IPs, etc.).
- Prepare media when assigned and within the specified time.
- Update media orders on the request system daily.
- Perform general lab maintenance and housekeeping per department procedures.
- Participate in audit readiness initiatives. Report any deficiencies or malfunctions immediately.
- Create and foster a team oriented environment by demonstrating respect and appreciation for differences in perspectives and approaches among colleagues.
- Identify opportunities to help others.
- Maintain professionalism in the presence of conflict.
- Provide exceptional customer service. Immediately address any customer inquiries and requests. Be willing to adjust workload to accommodate rush requests. Report any customer issues immediately.
- Develop, establish and monitor documentation per established procedures.
- Review all data fields, supplies used, labels, and calculations to ensure accuracy and completion per established procedures. Report any ongoing errors to the supervisor.
- Ensure training is accurate and kept updated for all areas of Buffer Prep. Attend GMP / GLP / GXP courses annually or as required. Complete training records in a timely manner. Coach and train Technicians.
- Assist in executing and monitoring a training plan for new personnel including ongoing feedback and provide training to other technicians as requested.
- Be fully accountable for the Media Prep group and perform all tasks to ensure success.
- Adhere to appropriate laws, FDBT regulations and programs, and GMP, GXP, and GLP guidelines.
- Initiate and monitor team to participate in process improvement initiatives for media, equipment, or procedures.
- Troubleshoot issues with media, processes, or equipment, and report any issues immediately. Follow up as necessary to ensure resolution.
- Adjust to schedule changes, work overtime as necessary, and be willing to support all Media Prep labs as needed.
- Ongoing development of technical expertise relevant to the scientific principles and technologies related to media development and preparation.
- Evaluate new equipment, technologies and business processes to enhance media preparation operations.
- Other duties as assigned.
Required Skills & Abilities:
- Experience in a GLP, GMP, or GXP environment.
- Must possess effective time management and organizational skills, strong math skills, strong problem solving skills, ability to work independently, good interpersonal communication skills, and demonstrated strong customer serviced skills.
- Must have ability to follow written procedures and quality compliance requirements.
- Must have strong initiative and focus on safety, quality, accuracy, and be detail-oriented.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to meet the following standards:
- May be required to work 2nd shift (currently 2 PM – 11 PM) and may be required to work weekends, off-shifts, and overtime as required.
- No make-up or jewelry can be worn when working in the clean room environment.
- Expected to be on feet standing or walking for up to 90% of shift.
- Ability to lift up to 40 lbs.
- Work with and around pressurized tanks, housings and equipment, which are connected by piping and pumps and serviced by pressurized steam, water, air and cleaning/sanitizing chemicals systems.
- Don gowning in the form of hospital scrubs, coveralls and safety toe footwear with shoe covers multiple times per shift.
- Don lab coats as well as safety glass/goggles, gloves (nitrile or latex) multiple times per shift.
- Handle and work with hazardous materials and chemicals per OSHA guidelines.
- Use hearing protection and dust masks as required.
- Utilize keyboard and mouse to interact with process automation systems as well as email, word processing/spreadsheets and other online computer systems.
- Manipulation of process equipment, connections and raw materials may require bending and reaching as well as repetitive twisting gripping hand motions. Where mechanical stress or pressure can be transmitted to the palm and the fingers during hand tool use, especially when large forces must be exerted. Forces should not exceed 22 pounds/inch2 (10 kg/cm2).
- May be assigned to 2nd shift (currently 2 PM – 11 PM) and may be required to work weekends and holidays.
- Attendance is mandatory.
- Bachelor’s Degree plus three (3) years’ experience of which two (2) years must be GXP experience; OR
- Associates Degree plus five (5) years’ experience of which two (2) years must be GXP experience; OR
- High School Diploma/GED plus six (6) years’ experience of which two (2) years must be GXP experience.
- Must also have completed at least one (1) Biotech course/training.
- GMP Experience.
- Biotechnology experience.