- Operation and familiarity with the following systems:
- Large-scale filtration systems including Tangential Flow Filtration (TFF) and depth filtration.
- Large-scale centrifugation systems including Sucrose Density Centrifugation, Continuous Flow Centrifugation, and Clarification.
- Large-scale Chromatographic systems (ÄKTA).
- Experience with single use systems.
- 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(s) 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 (Word, Excel, PowerPoint).
- 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 preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with 4 years of experience in a manufacturing environment which includes 2 years of GXP experience and lead or supervisory experience; OR
- Bachelor’s degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with 6 years of experience in a manufacturing environment which includes 2 years of GXP experience and lead or supervisory experience; OR
- High School or Associates Degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with 10 years of experience in a manufacturing environment which includes 5 years of GXP experience and lead or supervisory experience.
- Biotechnology Certificate
- Six Sigma 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.com or call 979-431-3528.