Kelly Science and Clinical are seeking a Director of Cell Therapy Manufacturing Operations for a client located in Philadelphia, PA.

Salary: $140,000-160,000/year

Employment Type: Full Time; Direct Hire

Travel requirements: 25%

Summary:

As the Director of Cell Therapy Manufacturing Operations, you will be responsible for serving as a technical expert on cellular therapy manufacturing operations, both internally and in the client's work with hospitals, biotech, and pharma companies with PHS 351 starting materials and PHS 361 transplant/transfusion products. Provide direct manufacturing operational oversight of all aspects of the Therapeutic & Cellular Solutions (TCS) Labs as SME, applying knowledge of transfusion/transplant clinical biology/biochemistry and hematology as applied in cell and gene therapy process and cell therapy operations, such as cellular isolation with cryopreservation as-a-service. Act as a facility, equipment, logistics, and product SME for other Cellular Therapy labs within the internal system. Provide consultation to internal customers; consult with external vendors. Lead and participate in cross-functional initiatives to advance our execution and delivery of high-quality TCS lab services to hospitals, biotechs, pharma companies, and patients. Maintain knowledge of and perform duties in compliance with applicable regulations and standards, such as FACT, AABB, 21CFR 200, 211, 600, 610, and 1271, EU/Eur.Ph., and USP. Travel and conference participation is required to remain current in practice.

Perform all duties and responsibilities in compliance with standard operating procedures and other applicable Federal, State and local regulations. Provide support, development and/or leadership guidance to all volunteers.

Scope

Establish operating policies and procedures that affect departments and subordinate sections and work units. Interpret company-wide policies and procedures. Develop budgets, schedules, and performance standards. Lead, mentor and train team members. Provide effective leadership including individual performance goal setting, managing the development of entire team and all individuals, recognize and reward employee contributions, planning and facilitating team activities, responsible for hiring and selecting new personnel and motivating members of the functional area.

Responsibilities

• Provide direct operational oversight of the Therapeutic & Cellular Solutions Labs. Manage a team including hiring, training, coaching, evaluating and managing performance. Manage resource allocations and oversee/coordinate staff training and assignments. Foster a culture of accountability and high performance.
• Collaborate with client stakeholder departments such as Quality Assurance and Supply Chain to ensure that the TCS Labs are compliant with all federal/state/local regulations, applicable accreditation agencies (e.g., FACT), and both client and internal policies/procedures as applicable. Cross-functionally partner with Biomedical and TCS Collections, Sales, Process and Project Management teams to ensure alignment between operational capabilities and client demands.
• Coordinate, authorize, and execute protocols related to manufacturing for research, clinical development, and commercial cell-based products requiring cell isolation and cryopreservation.
• Manage and operate ISO 7 cleanroom capabilities according to standard operating procedures. Accountable for execution of manufacturing contracted products and services.
• Oversight of liquid nitrogen (LN2), dry ice, and network cryogenic storage capabilities. In addition, a key responsibility will be to optimize cryogenic logistics and develop a suite of tools like lane mapping and feasibility, risk assessment of the lane, and effort required to establish relationships with air and ground freight providers serving local, domestic, and international destinations. Work with internal partners to accomplish goals.
• Oversight of procurement, warehousing, and logistical activities in line with budgetary and procedural needs throughout the lab network.
• Accountable for communicating budget expenditure resulting from continuous process and manufacturing improvements. Responsible for ensuring all revenue is effectively captured.
• Serve as a technical resource for other TCS Labs throughout the internal system; display expertise externally at industry conferences and hospital seminars.

Qualifications:

• Bachelor's degree in Life Sciences, Operations Management, Medical Technology or a related field. PhD strongly preferred.
• 7+ years of experience in hospital/pharmaceutical/biotech industry with at least 2 years in a leadership role focused on operations or quality within a client servicing organization.
• Must have strong knowledge of sterile manufacturing processes and regulatory requirements (FDA, cGMP, etc.)
• Must have strong interpersonal and communication skills, with the ability to effectively engage and influence stakeholders at all levels, including clients.
• Strongly preferred qualifications include:
• Experience within contract manufacturing
• Knowledge of clinical microbiology,
• Having a working knowledge of tissue culture techniques, flow cytometry, sterility testing and/or NAT- based assays.

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. You must be able to stand for long periods of time, repeat the same movements, use hands to handle, control or feel objects, tools or controls. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. This job requires the ability to hear and speak clearly. The employee must frequently lift and/or move up to 15 pounds and occasionally lift and/or move up to 30 pounds. The work environment will consist of moderate noise. The employee must be able to react quickly using hands, fingers or feet. This job may require the employee to be able to bend, stretch, twist or reach out. This position will require the ability to use stomach and lower back muscles to support the body for long periods of time and the ability to keep or regain the body’s balance or stay upright when in an unstable position. Employee must be able to frequently use one or two hands to grasp, move or assemble objects. The employee must have the ability to sit at a computer terminal for an extended period of time.