Operational oversight of the following systems dependent upon assignment:
Upstream Unit:
- Single-Use Cell Culture Vessels/Bioreactors up to 2000L
- Bacterial Fermentation Culture Vessels up to 2000L
- Alpha Wasserman Continuous Flow Centrifuges
- Disposable Magnetic Mixing Bags and Totes
- Cell Expansion and Propagation
- Banking/Cryopreservation of Cell Lines and Viruses
- Hyperstack, Cellstack and other adherent cell technologies
- Plate counting, microscopic examination
- Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation
Downstream Unit:
- Medium to Large-scale filtration systems including Tangential Flow Filtration (TFF) Hollow Fiber Tangential Flow Filtration (HFTFF), Nanofiltration and depth filtration.
- Medium to Large-scale Chromatographic systems (ÄKTA)
- Pre-Packed Columns from 1L to 100L
- Single use mixing systems (Pall & GE)
- Single Use connectivity types such as GE DAC and Colder AseptiQuik
- Plate counting, microscopic examination
- Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation
- Bulk filling
- Aseptic process simulation and drug product filling
Solution Preparation Unit:
- Preparation of medium from stock raw materials including the compounding, mixing, testing and filtration for further process needs
- Preparation of buffers from stock raw materials including the compounding, mixing, testing and filtration for further process needs
- Weighing of raw materials per batch record specifications and assignment of appropriate expiry per procedures
- Integrity testing of filters
Essential Functions Include:
- 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
- Execution of SAP functionality for batch close out and generating SAP reports as required.
- Develop, write, and review Standard Operating Procedures, Buffer Formulation Records 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 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, 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.
- Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
- Ability to wear personal protective equipment including safety glasses, lab coat, safety shoes and gloves.
- Ability to lift/pull/push up to 25 pounds frequently and up to 50 pounds on occasion.
- Attendance is mandatory.
Minimum Qualifications:
- Master’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with three (3) years of relevant experience; OR
- Undergraduate degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with five (5) years of relevant experience; OR
- Associates degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field and seven (7) years of relevant experience; OR
- High School/GED with nine (9) years of relevant experience.
- A minimum of two (2) years of formal or informal leadership experience required.
- A minimum of three (3) years of experience in a GMP environment.
Preferred Qualifications:
- Biotechnology Certificate
- Green-Belt Certification
- Experience with mammalian, insect, yeast, or bacterial cell lines and their cultivation and/or purification of biologics or viral vectors produced from such.