Bioprocess Manufacturing Technician

Title: Bioprocess Manufacturing Technician

Location: 4038 Avenida De La Plata Oceanside CA 92056
Shift Info:
10 hr Day Shift, 7:00 am – 5:30 pm

Sunday - Wednesday

Wednesday - Saturday

10 hr Swing Shift, 3:30 pm -2:00 am

Sunday - Wednesday

Wednesday - Saturday

Job Description

Position Overview:

At Genentech, we are dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. As a Bioprocess Manufacturing Technician, you will be responsible for producing medicine in a highly automated and controlled environment. Each product has a specific recipe; you will follow this recipe, along with the standard operating procedures, to operate the production equipment across various areas, including raw material dispensing/aliquoting, cell culture, and purification. You will maintain records and follow all the steps necessary to comply with regulatory requirements within a current Good Manufacturing Practices (cGMP) environment. We have both Stainless Steel and Single-Use Manufacturing facilities that are supported by Production Services.

There are 3 main production areas within manufacturing. As a new member of the team, you’ll typically be assigned to one of these three areas, with the potential to rotate into future production areas as you gain experience:

· Production Services:

Responsible for weighing and aliquoting of raw materials and small scale solution prep. Also responsible for washing, autoclaving, and preparation of small equipment parts and assemblies. Responsible for environmental monitoring of the facility.

· Upstream Manufacturing:

Responsible for cell growth from inoculation in spinner flasks through large scale bioreactors and the harvesting of cell culture via centrifugation and depth filtration.

· Downstream Manufacturing:

Responsible for the purification of cellular harvest utilizing chromatography and reformulation techniques, as well as preparation of product for shipping to final fill/finish sites.

Job Responsibilities:

Safety is paramount to both our employees and our patients, and is therefore at the core of all job responsibilities. This includes complying with all safety requirements, cGMP, Standard Operating Procedures (SOP) and manufacturing documentation. You must immediately report any and all safety and environmental incidents, including injuries, illness, near miss & safety suggestions.

Additional responsibilities may include:

• Utilizing automated systems to operate, clean and sterilize production equipment.
• Operating small-scale cell culture areas and systems by using aseptic techniques, maintaining cell banks; and performing general seed lab operations.
• Operating fermenters, centrifuges, other harvest systems and protein purification units.
• Operating and cleaning fixed tank and filtration systems.
• Operating large scale column chromatography systems.
• Preparing solutions required for the production process (media and buffer make-up).
• Cleaning, assembling, and sterilizing equipment for production by operating glass washers and autoclaves.
• Executing environmental monitoring throughout the facility.

Ideal Candidate Attributes:

• You’re a quick learner and can receive, digest and interpret instructions with ease.
• You’re technically and mechanically inclined and can learn new systems and technology quickly.
• You find joy in the details and pride yourself in accuracy.
• You can work independently but as part of a larger team.
• You can demonstrate the ability to independently document and record information.
• You showcase good judgment and ability to recognize non-routine problems/deviations and escalate to partner on potential solutions.
• You demonstrate increasing technical competency through training and operational procedures of at least one manufacturing department.
• You manage your time and communicate effectively with your team members.

Shift Details & Requirements:

We have a variety of 10-hour shifts to support our 24x7 facility operations. Staff working over 8 hours in a day will be paid overtime in accordance with local and state laws. In addition, staff working swing or night shifts will be paid a shift differential. While we are occasionally able to accommodate shift requests, candidates with open availability will be given priority consideration as we are not able to guarantee shift placement.

Candidates must be able to work any of the following manufacturing shifts:

• 10 hr Day Shift, 7:00 am – 5:30 pm
• • Sunday - Wednesday
  • Wednesday - Saturday
• 10 hr Swing Shift, 3:30 pm -2:00 am
• • Sunday - Wednesday
  • Wednesday - Saturday

Qualifications / Requirements:

• Proficiency in the English language - reading, writing, and communication.
• Must be computer literate due to the extensive automation used in our facility, experience with Microsoft and Google platforms.
• Must be able to work all shifts, required overtime as needed, and stand for extended periods of time.
• Our facility is expansive - you may climb multiple flights of stairs daily.
• Lifting up to 25 lbs is required.
• You may work with hazardous materials and chemicals.
• Must be able to successfully pass all job-related tests and certifications required for working in a cGMP, quality environment including but not limited to: inspections and GMP requirements to perform essential functions of the job.

Educational Requirements

• High school diploma or equivalent
• Preferred - Degree in Life Sciences/Engineering, Associate’s or Biotech certificate from approved program