University of Florida - Alachua, FL

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The Director of Downstream Process Development and GMP Manufacturing (Asst Director 2, Research Programs/Services) at Center of Excellence for Regenerative Health Biotechnology Florida Biologix directs downstream process development activities and cGMP compliant purification operations related to column chromatography (affinity, size exclusion, anion/cation membrane absorbers, HIC , etc.) filtration, centrifugical and other separation-based methods for proteins, viral vectors and large and small molecules. These activities fulfill contract requirements, providing customers with high quality biopharmaceutical products suitable for research, pre-clinical and clinical use. The Director provides coordination, leadership, scientific and technical expertise for all such projects. The incumbent is responsible for the activities in Downstream Process Development and Downstream GMP Manufacturing groups, ensuring that these activities are timely, efficient and productive while adhering to client’s requirements, operational/quality parameters and cGMP standards. The Director is also responsible for maintaining cGMP compliance in his/her areas of responsibility by modifying, reviewing and approving documents (SOPs, Batch Records, Specifications, Validation and Qualification protocols, PDPRs, etc.) and for operating within project and department budgets. The incumbent serves as the supervisor for Downstream Process Development and Downstream GMP Manufacturing Managers, Scientists and Technicians and therefore is also responsible for review of their hiring, training, goal setting and performance evaluation. This individual works closely with the Upstream PD and Manufacturing groups, Fill/Finish, Quality Control, Quality Assurance, Project Management, Marketing, Administration, and Facilities teams in the execution of all responsibilities and for the planning and implementation of new processes and of technology, sourcing raw materials, reagents, process equipment and facilities modifications/validations as they become necessary. The Director attracts, facilitates, participates in contract development and maintains good relations and communications with clients as a primary technical interface between the client’s technical staff and FB. This person works with vendors supporting Downstream PD and Manufacturing activities while planning, implementing, and coordinating the optimization of the manufacturing processes requiring application of sound scientific principles. The incumbent assists Senior Management in the development, interpretation and implementation of UF and FB policies and procedures as they apply to the assigned areas of responsibility.

35% – Operations
• Identify, plan, organize, coordinate and execute all Downstream Process Development and GMP Manufacturing projects while applying sound scientific principles. Analyze PD and Manufacturing data and work with QC PD and QC to develop appropriate sampling plans and QC assays requirements. Meet all contract requirements to assure on-time, on-budget supply of products suitable for research, pre-clinical and/or clinical use, as specified.
• Ensure that the Downstream Process Development Laboratories and Manufacturing facilities operate efficiently considering the conditions of the facilities, reagent and raw materials sourcing and inventory, project scheduling, staff utilization, process and storage equipment usage and the purchase of needed processing and storage equipment.
• Make decisions/recommendations as to the implementation of new processes or equipment and of changes in same in consultation with senior managerial staff, QA and the client, when appropriate.
• Work with senior management to develop strategic plans for staffing, facilities and equipment requirements to meet current and future downstream process development and Manufacturing activities.
• Assure that department activities and facilities are in compliance with cGMPs, FB Quality Systems, Preventive Maintenance, change over cleaning, calibration and validation and revalidation schedules, safety requirements and FB policies. Review and approve process development reports, batch records, deviation reports, investigations reports. Investigate issues and trouble-shoot. Recommend changes in FB policy/procedures as needed.
• Perform hands-on activities when required in the PD lab and GMP facility according to written procedures in compliance with cGMP regulations. Be gowning qualified as required. Monitor the outcome of media fills, aseptic process simulations, and room qualifications.
• Assist in the preparation and review of general manufacturing and facility related documents and records.

25% – Supervision
• Hire appropriate Downstream Process Development and GMP Manufacturing staff, as budgets allow, providing the required experience as needed for project implementation and successful completion.
• Ensure that subordinates are properly trained while clearly communicating the expectations, schedules, safety concerns and duties of their jobs. Provide goal setting and performance evaluations.
• Ensure that personnel perform and interact with all other FB staff in a manner which meets the requirements for the manufacturing of human biopharmaceutical products and professional and courteous teamwork.
• Ensure that the Downstream Process Development and Manufacturing staff understand and meet all appropriate regulatory standards, providing guidance, discipline, and that they follow standard operating procedures. Participate in annual safety training and as needed training on policies, cGMP regulations, and customer’s requirements and ensure that subordinates do the same.
• Participate on Executive Committees when asked.

20%- Communications
• Meet weekly with FB Directors/managers to communicate and coordinate Downstream Process Development and GMP Manufacturing activities to meet timelines as well as coordination of activities with all internal departments and outside service contractors, service personnel, and vendors as necessary.
• Participate in a weekly meeting with Director and Associate Director CERHB and the Process Development staff (as designated) to discuss experimental data, PD plans and progress.
• Participate in project meetings as required.
• Communicate daily as needed to ensure coordination of activities between Downstream PD and Manufacturing staff and other FB depts. to ensure progress on projects.
• Present at public meetings when requested.

10% – Client Interaction
• Attract and communicate effectively with prospective clients acting as a primary technical contact for downstream activities. Attend site visits as applicable.
• Participate in the development of potential project proposals focusing on technical aspects of the proposal/contract.
• Attend project meetings as scheduled by Project Management for each project involving Downstream PD or GMP Manufacturing activities to report on progress. Assist Project Managers with maintaining accurate meeting minutes. Oral and written presentations to clients are required.
• Participate in marketing activities, as needed, and review all marketing literature pertaining to areas of responsibility.

5% – Budget
• Improve and make more time/cost efficient the downstream process development laboratories and GMP Manufacturing facilities and respective procedures.
• Prepare the yearly department budget and operate within same. Interact with Supply Chain Manager to ensure lowest cost but required specifications of materials and equipment are met. Assist in negotiation with supply contractors and material vendors to identify and ensure cost saving options. Participate in the development of project pricing.

5% – Other
• Other duties as assigned.

Minimum Requirements:
Master’s degree in an appropriate area of specialization and two years of appropriate experience; or a bachelor’s degree in an appropriate area of specialization and four years of appropriate experience.

Preferred Qualifications:
MS degree in an appropriate area of specialization with a minimum of ten years of hands- on, practical process development experience in purification of proteins and vectors from mammalian and insect cell culture.
Hands-on experience with SOP and batch record development, laboratory equipment maintenance, calibration, cleanroom operations, change over cleaning and GMP downstream purification of large and small molecules is required.
Conversant about process development activities, as well as the basic elements of product formulation, stability protocols, process and methods validation as well as equipment and facility qualification practices.
Must have working knowledge of modern laboratory procedures, as well as, experience in aseptic Biologics operations including hands-on experience with affinity, anion and cation membrane absorbers, TFF , diafiltration, centrifugal methods and viral clearance evaluation.
Have experience based, thorough understanding of cGMP and FDA /EU requirements, NIH regulations, and other regulatory experience such as regulatory inspections, CMC preparation and the ability for technical writing.
Have leadership, delegation, and motivation skills to effect performance of individuals in the area of responsibility and throughout the organization, including 2 years of supervisory experience.
MS Word, MS Access, MS Excel, MS PowerPoint, MS Outlook, and MS Project experience mandatory.
Highly motivated, organized, and detailed oriented. Self-starter with the ability to work productively and independently and to solve problems. Proven ability to manage multiple projects and responsibilities simultaneously and prioritize tasks in order of importance. Excellent oral and written communication skills.

Health Assessment Required:

Special instructions to applicants:
This is a time-limited position.

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