- Management of the technical operations team.
- Leadership and building teams to support client and regulatory agencies in face-to-face interactions.
- Ownership of methodologies and support packages.
- Interface with internal/ external technical experts and peers to maintain a broad knowledge of the technology and regulatory issues that impact on the biopharmaceutical/gene therapy businesses enabling technology options to be identified, evaluated, and compared
- Manage and lead the seamless transfer of new processes and technologies to the National Center for Development and Manufacturing and Flexible Biomanufacturing Facility 200, ensuring requirements for health and safety and cGMP compliance are delivered.
- Ensure best practice operating methods are deployed by providing System Ownership.
- Resolve operational problems such as deviations/ QIPs/ CAPAs by acting as System Owner.
- Lead investigations into events arising from compliance issues.
- Ensure implementation of e-learning, video, classroom and in suite design and delivery as appropriate.
- All other duties as may be assigned or required.
Ensure the Technical Operations Team works independently and with colleagues to provide expertise and assistance for the design, development, standardization and maintenance of operational biotechnology utilized in the manufacture of drug substances and other process intermediates.
As a CDMO, customer liaison is a vital part of our business; the Technical Operations team will act as a point contact for our customers during manufacturing execution.
This leadership position will ensure the team becomes the subject matter experts on a set of the core manufacturing and operational technologies for the manufacturing unit. Operational biotechnologies include: Isolators and incubators and their use in cell propagation, Cell Culture/Single Use Technology, Adherent cell culture technology, Filtration, Chromatography and Final Filtration. Core manufacturing technologies include Weigh and Dispensing and Mixing and Buffer Preparation.
Develop and maintain equipment and unit operation standards and procedures utilizing 4M (Man, Materials, Machinery and Methods) approach including:
- (Man) Develop and deliver effective skill building and training plans for a given operational technology to manufacturing technicians.
- Collaborate with individuals and teams of technicians & managers on self-development plans.
- Implement e-learning, video, classroom and in suite design and delivery as appropriate.
- Create and maintain the technical training manuals and personnel certification process.
- Assure local operational practice reflect local procedure and instruction.
- Provide guidance and direction on cross-functional training initiatives.
- (Materials) Understand process control and material inputs to ensure capable and acceptable process output.
- Create Process Consumables List for the Manufacturing Campaign to enable Supply Chain in procurement activities and creation of process orders
- Create new material specifications, as needed.
- (Machinery) Understand technology operation capabilities, limits and control strategies
- Lead coordination of the selection of existing process equipment for use in each customer program.
- Review and/or Approve equipment qualification limits.
- Review Calibration Tolerances and Approve Out of Tolerance Investigations
- Represent the manufacturing unit for equipment purchase, new technology and changes to equipment.
- Prepare room/equipment layout as part of new product introduction.
- (Methods) Develop and maintain Technical Operational Manuals/Standard Operating Procedures/Work Instructions/Batch Records.
- Lead operational technology standardization, standard batch templates and instruction interfaces and lead continuous improvement for a given technology.
- Interface with Process Development to ensure smooth transfer of processes into the manufacturing plant.
- Develop and approve procedures and batch records.
- Create Standard Work for manufacturing readiness, execution, and batch disposition activities.
Required Skills & Abilities:
- Demonstrated leadership ability with proven communication success
- Excellent oral and written communication skills, interpersonal and organizational skills.
- Ability to train others to perform to cGMP standards.
- Proficient with Microsoft Office applications.
- Good self-discipline and attention to detail.
- Must have flexible work hours – must be willing to work outside of normally-scheduled hours as necessary; including opportunities for alternative shift-hours and weekends as required.
- Excellent math and computer skills.
- Experience working in cleanroom environments.
- Must have good planning skills and must be willing to interface with and guide colleagues in many different roles and functions throughout the manufacturing facilities.
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:
- Experience prolonged standing, some bending, stooping, pushing, pulling, reaching above shoulders and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
- Lift up to 25 pounds frequently and up to 50 pounds, on occasion.
- Attendance is mandatory.
- Bachelor’s degree preferably in Science, Engineering or other related field and eight (8) years of relevant related experience including four (4) years of supervisory/management experience; OR
- Associate’s degree preferably in Science, Engineering or other related field and ten (10) years of relevant related experience including four (4) years of supervisory/management experience.
- Above experience must include four (4) years’ GMP experience.
- Experience in transfer of processes.
- Experience conducting and evaluating training.
- Experience with manufacturing instruments/equipment.
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 e-mail FDBTHR@fujifilm.com or call 979-431-3528.