Full Time

Director, Drug Product Operations

Posted 1 month ago
Application ends: June 29, 2023
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Job Description

Overview The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive – what FDB call Genki. External US College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas’ population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area. The Head of Drug Product Operations is responsible all operational aspects of drug product projects at FDBT. Reports to Vice President, Engineering and Asset Development Work Location College Station, TX Primary Responsibilities: Provides leadership for manufacturing operations of the drug product team. Maintain focus on continuous reduction of risk to patient through deploying engineering and procedural controls while delivering operational requirements. Create alignment with other stakeholders required across program lifecycle: winning the program, on boarding the program, transferring the program into Drug Product Ops, execution of manufacturing activities, qualification, regulatory document support, and ongoing maintenance. The stakeholders include Business Development, Process Development, Process Sciences, Engineering, Quality Assurance, Quality Control, Facilities, EHS and Clients. Exhibit leadership through both role power and via influence. Hold the budget and ensure financial leadership for Drug Product department. Maintain Drug Product operations in compliance with FDA and EU requirements. Set up robust controls for Drug Product programs where BDS is supplied from both internal and external sources. Set up robust training using both internal and external venues including succession planning. Take the lead in client audits and competent authority inspections. Provide data and support to the Global Business System Group (GBS) for drug product and packaging and labeling. Complete investigations in a timely manner and ensure root causes are correctly identified and documented. Develop and track to appropriate metric and reporting in a timely and transparent basis. Provide safety oversite and compliance with all EHS requirements. Hire, train, develop and evaluate staff. Take corrective actions as necessary on a timely basis and in accordance with Company policy. Ensure compliance with current federal, state, and local regulations in consultation with Human Resources as appropriate. Perform other duties and projects as assigned and required. Qualifications: Master’s degree preferably in business, engineering, science or related field with 10 years’ experience preferably in Biotechnology or Pharmaceutical Operations and 10 years’ experience in a managerial position; OR Bachelor’s degree preferably in business, engineering, science or related field with 12 years’ experience preferably in Biotechnology or Pharmaceutical Operations and 10 years’ experience in a managerial position; OR High School Diploma or equivalent with 20 years’ experience preferably in Biotechnology or Pharmaceutical Operations and 10 years’ experience in a managerial position. Represented DPO during regulatory inspection. Authored in part or whole CMC sections for DPO. Experience working with isolated filling systems. Validation and/or QA leadership. Both CMO and Development company experience. Extensive, demonstrated experience in the life cycle of drug product operations. Clear leadership qualities and demonstrated success in management including both role power and influence with colleagues. Demonstrates managerial maturity in fast-paced development and operational environments. Requires strong analytical and communication skills including both oral and written. Ability to translate high-level guidance into executable plan including buy-in from stakeholders. Ability to prioritize work to meet deadlines. Demonstrated ability break up complex activities into delegated pieces to enable timely execution. Transparent, detail oriented and accurate. Excellent computer skills and proficient in MS Office (Work, Excel, Outlook, PowerPoint) and MES/data historian use. Strong interpersonal skills with an understanding of diverse backgrounds and an emphasis on communication: training, team building, negotiation skills, interdepartmental interactions, leadership and management. Ability to hire, train, and develop employees to grow within the organization. Role model for company core values of trust, delighting our customers, Gemba, and Genki. 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 essential functions. While performing the duties of this job, the employee is required on a regular basis to: Experience prolonged standing, some bending, stooping, and stretching. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. May be required to lift up to 40 pounds on occasion. Attendance is required. Join us FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large. We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please email FDBTHRfujifilm.com or call 979-431-3500. To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.