NOTE: This is a contract opportunity. Relocation is not budgeted for this role.

Summary

As a manufacturing technician you will be responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment while maintaining areas in a high state of inspection preparedness. Follows standard operating procedures to operate production equipment for cell culture or purification. Maintains records, process and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP). Responsible for being proficient in one functional area: Productions Services (PS), Upstream/Downstream Manufacturing. Understands and applies biological, chemical and mechanical principles and techniques.

Job Responsibilities
Comply with safety requirements, cGMP, SOP and manufacturing documentation.

Immediately report safety and environmental incidents, including injuries, illness, near miss & safety suggestions.

Utilize automated systems to operate, clean and sterilize production equipment.

• Operate small-scale cell culture areas and systems by operating cleaning, set up, and maintaining 20L batch feed fermenters; inoculating and maintaining spinner seed cultures using aseptic techniques, maintaining cell banks; and performing general seed lab operations.
• Operate fermenters, centrifuges, other harvest systems and protein purification units.
• Operate and clean fixed tank and filtration systems.
• Operate large scale column chromatography systems.
• Prepare solutions required for the production process (media and buffer make-up).
• Clean, assemble, and sterilize equipment for production by operating glass washers and autoclaves.

Trained and skilled in all operational procedures of at least one manufacturing department.

Exhibit detail-oriented documentation and check all data entries (e.g. tickets, labels, equipment reading).
Demonstrated ability to independently document and record information related to the process.
Good judgement is required to recognize non-routine problems/deviations, escalate and partner on potential solutions.

Receive, interpret and provide basic information for systems and materials involved with the day to day activities of performing the job.

Work Environment/Physical Demands/Safety Considerations:

• Schedule could include a rotating (12 hour shift), one weekend day, evening, night, or full off-shift hours.
• Expected to be on feet for 8 to 11 hours a day.
• May climb multiple flights of stairs a day to maneuver within the manufacturing facility.
• Ability to lift up to 25lbs may be required.
• Environment requires daily gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots to be worn. 
• Usage of hearing protection and dust masks may be required.
• No make-up or jewelry can be worn when working in the clean room environment.
• May work with hazardous materials and chemicals.

Skills

• Foster a safe and collaborative work environment.
• Strong oral and written communication and the ability to collaborate with a team.
• Exhibit professional interpersonal skills.
• A good working knowledge of biopharma technology and processes. 

Education

REQUIRED: High school diploma
PREFERRED: Degree in Life Sciences/Engineering, Associate degree or Biotech certificate from approved program.