Summary: The Senior Manufacturing Lead – Downstream will lead a team and work directly with a range of purification technologies including: filtration technologies (TFF and depth), chromatographic separations (Single Use GE AKTA systems), viral inactivation, etc. following aseptic techniques and procedures in a cGMP environment.
- Responsible for leading a team in the operation of chromatographic systems (Single Use GE AKTA).
- Responsible for coordinating daily manufacturing floor activities.
- Responsible for overseeing and preparing and formulating buffers in accordance to procedures.
- Responsible for writing, reviewing, and/or updating Standard Operating Procedures (SOPs) and Batch Production Records (BPRs).
- Document and maintain activity records according to cGMP regulations and ensure team members are properly trained on all proper processes.
- Coordinate and implement project safety and quality assurance programs in collaboration with senior staff and EH&S.
- Ensure proper documentation and execution of Batch Production Records for assigned projects.
- Maintain confidentiality of proprietary company information.
- Participate in and/or lead incident investigations.
- Maintain an effective working relationship with others.
- Perform all other duties as assigned.
NCTM/Building 200 Essential Functions:
- 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)
- Lead team in continuous flow centrifugation, sucrose gradient separation, various filtration technologies, chromatographic separations technologies, and viral inactivation following aseptic technique in a cGMP environment.
- Provide input and support to Process Development functions during development and scale up activities as necessary.
Building 100 Essential Functions:
- Ability to use and train employees with single use systems.
- Ability to operate and train employees on general production equipment such as Incubators, Analytical Scales, pH/conductivity meters, etc.
- Lead team on ultrafiltration using single use technology and aseptic final fill execution.
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.
- 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.
- Self-discipline and good attention to detail.
- 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, 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, 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 Mammalian Cell or Insect Cell, Yeast or Bacterial Cell lines.
- Six Sigma Certification