The Manager of Support Operations will be responsible for the comprehensive operation of cGMP Buffer/Media production suites, clean/sterile equipment preparation, raw material sampling, and Weigh/Dispense activities in a biopharmaceutical pilot scale/commercial launch facility. The individual will manage day-to-day operation of multiple suites providing various support services for the production of preclinical, clinical phase, and commercial launch Biologics materials including production/staff scheduling, generation/ approval/ close-out of all cGMP related documentation, preparation of assemblies and solutions, and suite change-over ensuring compliance to relevant regulations. The Manager will also be responsible for providing support services for cGMP suite cleaning and spent material removal, maintenance of consumable stocks, and movement of raw materials and solutions within the cGMP production suites.
1. Manage buffer and media weigh/dispense/production suites, clean/sterile assembly preparation, raw material sampling and dispensing. Drive the design, acquisition and implementation and of new technologies for buffer and media preparation. Assist with the transfer of new buffers and media formulations working with GMP Operations and Development laboratory personnel. Oversight of other areas within the facility may be added at the company’s discretion.
2. Provide general supervision for cGMP suite cleaning and waste removal, stocking of consumables, and movement of raw materials and solutions within the cGMP suites.
3. Provide direct supervision, training, and hands-on support of production staff in the operation of equipment to support preclinical, clinical phase, and commercial launch batches of all materials. Coordinate and supervise department change-over activities. Serve as the equipment and suite owner to coordinate routine suite and equipment maintenance, calibration, and validation with appropriate internal departments.
4. Coordinate the preparation/revision of master batch records, SOPs, and review/close-out all cGMP documents, including equipment and process deviations for each campaign.
5. Assist in troubleshooting equipment issues and batch/material related deviations. Provide timely reporting, investigation, and resolution of manufacturing process/product deviations, change controls, and commitments.
6. Ensure adherence of operations to cGMP, ICH, EMEA and JP Guidelines as well as industry safety standards and OSHA guidelines.
7. Interact cross-functionally with Upstream and Downstream Operations, Facilities, Quality Assurance, Quality Control, VTE, and other internal and external functions to support successful batch production.
8. Recruit, train, and develop staff supporting operations. Ensure staff are trained in cGMPs, process specific knowledge, equipment operation, and relevant regulations.
• Minimum of a Bachelors in biological sciences or engineering, business or technical management
• Minimum of 5-8 years in a multi-discipline cGMP production environment, initiating, scheduling, and managing Biopharmaceutical product manufacturing functions.
• Knowledgeable in operation of washers, sterilizers, and buffer/media single use solution prep equipment.
• Knowledgeable in cGMP equipment validation, trouble shooting, and maintenance.
• Ability to identify, investigate, and solve process, product and equipment problems.
• Strong working knowledge of US cGMP, EMEA, and JP regulations.
• Excellent written and communication skills.
• Excellent interpersonal skills.
• Team player who can excel in a “hands-on” entrepreneurial environment.
• Previous supervisory experience.
• Ability to train and develop subordinate technical staff.
• Fitness for the use of chemical safety respirators for solution handling required
Source: Job Diva – Job Listing