Summary: The Senior Manufacturing Lead – Upstream will lead a team and work directly with a range of technologies following aseptic techniques and procedures in a cGMP environment.
- Responsible for leading a team in preparing medium, monitoring cultures, taking samples, turn-around of bioreactors and inoculations.
- Responsible for coordinating daily manufacturing floor activities.
- Responsible for overseeing and/or performing cell counting and microscopic examination.
- Responsible for writing, reviewing, and/or updating Standard Operating Procedures (SOPs) and Batch Production Records (BPRs).
- Coordinate and implement project safety and quality assurance programs in collaboration with senior staff and EH&S.
- Maintain confidentiality of proprietary company information.
- Document and maintain activity records according to cGMP regulations and ensure team members are properly trained on all proper processes.
- Maintain an effective working relationship with others.
- Ensure proper documentation and execution of Batch Production Records for assigned projects.
- Participate in and/or lead incident investigations.
- Perform all other duties as assigned.
NCTM/Building 200 Essential Functions:
- 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
- Lead team in cell-culture and viral propagation techniques; cell-culture and bioreactor operations; bacterial and fermentation operations; pDNA, protein, and yeast-related operations; and aseptic techniques.
- Provide input and support to Process Development functions during development and scale up activities.
Building 100 Essential Functions:
- Lead team in working with mammalian cell culture processes including: shake flask inoculations, single use bioreactor operations, cell recovery, etc.
- Lead team to produce requirements in operating and monitoring equipment through observing varying conditions, adjusting equipment controls, calculating concentrations, dilutions, and yields.
- Ability to operate and train team in the use of general production equipment such as Incubators, Analytical Scales, pH/conductivity meters, etc.
Required Skills & Abilities:
- Excellent oral and written communication skills as well as excellent interpersonal and organizational skills.
- Demonstrated leadership skills.
- Ability to train others to perform and maintain cGMP standards.
- Strong proficiency with Microsoft Office applications.
- Experience working in cleanroom environments.
- Self-discipline and good 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-hour and weekends as required.
- Excellent math and computer skills.
- Must have exceptional planning skills and be willing to interface with colleagues in many different roles and functions throughout the manufacturing facilities and lead projects.
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, 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 3 years relevant experience of which 2 years must be in a GMP environment; OR
- Bachelor’s Degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering or related field with 5 years relevant experience of which 2 years must be in a GMP environment; OR
- Associates Degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with 7 years relevant experience of which 2 years must be in a GMP environment.
- High School Diploma or Associates Degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with 9 years relevant experience of which 2 years must be in a GMP environment.
- Experience with cultivation of cell culture vessels at the pilot scale level or greater.
- Experience with Mammalian Cell or Insect Cell, Yeast or Bacterial Cell Lines.
- Experience with MAb, pDNA, and/or Viral Propagation technologies.
- Six Sigma Certification