Summary: The Upstream Manufacturing Technician III will work directly with a range of technologies including cell-culture and viral propagation techniques; cell-culture and bioreactor operation; bacterial and fermentation operations; pDNA; Protein and Yeast related operations; as well as aseptic technique following GMP procedures.
- Responsible for medium, monitor cultures, take samples, turn-around of bioreactors and fermenters, sterilization and inoculation.
- Plate counting, microscopic examination.
- Write and review standard operating procedures and batch production records.
- Experience with cultivation and/or pilot scale cell culture vessels.
- Assist senior staff in implementing project safety and quality assurance programs in accordance with SOPs.
- Maintain the confidentiality of proprietary company information.
- Document and maintain activity records according to cGMP regulations and ensure junior team members are trained.
- Assist in the training and provide technical coaching to junior staff members.
- Perform daily cleaning and sanitization of the laboratory.
- Maintain an effective working relationship with others.
- Proficiency with BioCommand programming.
- Perform all other duties as assigned.
Required Skills & Abilities:
- Excellent oral and written communication skills, interpersonal and organizational skills.
- Excellent leadership skills.
- Ability to train others to perform to cGMP standards.
- Proficient with Microsoft Office applications.
- Good self-discipline and 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-hours and weekends as required.
- Excellent math and computer skills.
- Experience working in cleanroom environments.
- Must have good planning skills and must be willing to interface with and guide colleagues in many different roles and functions throughout the manufacturing facilities.
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, pushing, pulling, reaching above shoulders and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
- Lift up to 25 pounds frequently and up to 50 pounds, on occasion.
- Attendance is mandatory.
Technician III Minimum Qualifications:
- Master’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or other related field and 1 year of relevant experience; OR
- Bachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or other related field and 3 years of relevant experience; OR
- Associate’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or other related field and 5 years of relevant experience; OR
- High School/GED with 7 years of relevant experience.
- Above experience must include one (1) year GXP experience.
Technician III Preferred Qualifications:
- Biotechnology certificate preferred.
- Cross training with Downstream processes or other identified functional areas.
We will consider applicants that do not meet the minimum qualifications for a level III Technician should an applicant meet the level II Technician or Level I Technician qualifications listed below:
Technician II Minimum Qualifications:
- Bachelor’s degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field, and 2 years of relevant experience: OR
- Associate’s degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field, and 3 years of relevant experience; OR
- High School/GED with 5 years relevant experience.
Technician II Preferred Qualifications:
- Experience in GMP environment
- Biotechnology Certificate
Technician I Minimum Qualifications:
- Associate’s degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field; OR
- High School Diploma/GED and 1 year of work experience.
Technician I Preferred Qualifications:
- Experience in a GMP environment
- Biotechnology Certificate