Manufacturing Bioprocess Technician

Lancesoft; Oceanside (CA); On-site; USD 42,000 - 70,000; Full time

Job summary

Lancesoft seeks a Bioprocess Manufacturing Technician to produce medicines in a highly automated, cGMP environment. You will follow recipes and SOPs, operating equipment across raw material dispensing, cell culture and purification, while maintaining records to ensure regulatory compliance.

This contract role supports 24x7 operations with various 10-hour shifts; overtime and shift differentials apply. Strong attention to detail and team collaboration are essential for success.

Qualifications

• English proficiency as primary requirement.
• Computer literacy for automation and documentation.
• Attention to detail and accuracy in record-keeping.
• Willingness to work in a cGMP environment and follow SOPs.

Responsibilities

• Operate automated production equipment and assist in cleaning and sterilization.
• Perform aseptic procedures in cell culture areas and maintain cell banks.
• Operate fermenters, centrifuges, harvest systems and protein purification units.
• Operate large-scale chromatography systems and contribute to formulation activities.
• Prepare solutions required for the production process (media and buffers).

Skills

English proficiency

Computer literacy

Attention to detail

Teamwork

Education

High school diploma or equivalent

Life sciences/engineering degree or certificate

Tools

Microsoft Office

Google Workspace

Job description

Summary:

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. This is a contract role with the possibility of conversion to a permanent employee position. We have both Stainless Steel and Single-Use Manufacturing facilities that are supported by Production Services. There are 3 main production areas within manufacturing: 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. We are currently seeking candidates for the Single-Use Manufacturing Facility.

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.

• 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 large scale column chromatography systems
• Preparing solutions required for the production process (media and buffer make-up)

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 elevate 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

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

Onboarding will consist of a 3-4 week schedule of Monday thru Friday 8am - 5pm followed by on the job training on the respective shift schedule.

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.
• The cleanroom environment requires gowning in the form of cleanroom scrubs, bunny suits, gloves, hair covers, safety glasses, and steel toe boots be worn. No makeup or jewelry can be worn when working in the clean room environment.
• Personal electronic devices (e.G. Cell phones) are not permitted in cleanrooms without formal approval due to health authority regulation.
• 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