- Operation of the following systems:
- Single-Use Cell Culture Vessels/Bioreactors up to 1000L
- Bacterial Fermentation Culture Vessels up to 1000L
- Alpha Wasserman Continuous Flow Centrifuges
- Disposable Magnetic Mixing Bags and Totes
- Cell Expansion and Propagation
- Banking/Cryopreservation of Cell Lines and Viruses
- Plate counting, microscopic examination.
- Prepare medium, monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation.
- Responsible for supervising daily manufacturing activities and staff, including hiring, performance evaluations, coaching, mentoring, disciplinary actions, termination recommendations, training, development, etc.
- Responsible for implementing project safety and quality assurance programs
- Develop, write, and review Standard Operating Procedures and Batch Production Records (BPRs).
- Responsible for ensuring proper documentation and execution of BPRs and activity records, according to cGMP regulations.
- Lead deviation resolution and closure with subject matter expert and quality teams.
- Responsible for tracking CAPAs to closure.
- Provide input and support to R&D functions during development and scale up activities as necessary.
- Represents organization in client meetings as the subject matter expert with regard to assigned manufacturing processes.
- Ensure an adequate supply of materials available; ensure all materials for project are procured prior to production.
- Maintain the confidentiality of proprietary company information.
- Responsible for continuous improvement in areas of responsibility.
- Maintain an effective working relationship with others.
- Perform all other duties as assigned.
Required Skills & Abilities:
- Demonstrated leadership, coaching and mentoring skills.
- Demonstrated experience in training others to perform and maintain cGMP standards
- Excellent skills with Microsoft Office applications.
- Must have flexible work hours, and be willing to work outside of normal, scheduled hours; as necessary. Must be able to work alternative shift hours and weekends as required.
- Excellent self-discipline and attention to detail.
- Advanced math and computer skills.
- Must have exceptional planning and organizational skills, excellent oral and written communication skills, and be proactive in process interfacing with colleagues in various roles and functions throughout the manufacturing facilities.
- Demonstrated ability to work with teams and collaborate with others.
- Excellent problem-solving skills.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee, in order 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, pushing, pulling, reaching above the shoulder, stooping, and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
- Ability to lift up to 25 pounds frequently and up to 50 pounds on occasion.
- Attendance is mandatory.
- Master’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with 4 years of experience in a manufacturing environment which includes 2 years of cGMP experience and at least 1 year of lead or supervisory experience.
- Undergraduate degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with 6 years of experience in a manufacturing environment which includes 2 years of cGMP experience and at least 1 year of lead or supervisory experience.
- Experience with cultivation at a minimum of pilot scale cell culture vessels.
- Experience with Mammalian Cell, Insect Cell, Yeast and Bacterial Cell Lines.
- Experience with MAb, pDNA, and Viral Propagation technologies.
- Biotechnology Certificate
- Green-Belt Certification
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.comor call 979-431-3528.