Summary: The Manufacturing Supervisor will work directly with a range of purification technologies including viral filtration, Tangential Flow Filtration, Depth Filtration, Dead-end Filtration, chromatographic separations technologies (GE AKTA systems), Viral Inactivation and Final Filling Operations following cGMP requirements. This individual will also supervise a team of employees directly or indirectly in the Downstream process.
- Operation and familiarity with the following systems:
- Medium to Large-scale filtration systems including Tangential Flow Filtration (TFF) and depth filtration.
- Medium to Large-scale Chromatographic systems (ÄKTA).
- Pre-Packed Columns from 10L to 100L.
- Single use mixing systems (Pall & GE).
- Single Use connectivity types such as GE DAC and Colder AseptiQuik
- SAP Inventory control and consumption
- Responsible for supervising daily manufacturing activities and staff, performance evaluations, coaching, mentoring, disciplinary actions, 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 Process Development and Technical Operation 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.
- Promote and facilitate cross functional training within the organization
- 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 in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field and 3 years of relevant experience; OR
- Bachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field and 5 years of relevant experience; OR
- Associates degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field and 7 years of relevant experience; OR
- High School/GED with 9 years of relevant experience.
- Above experience must include three (3) years of cGMP.
- Biotechnology Certificate
- Six Sigma Certification