Title: Manufacturing Bioprocess Technician I Location: Oceanside, CA, 92056 Duration: 4+ months
Shift Details: The position is located in Oceanside, on-site. The schedule could include a rotating (10–12-hour shift), one weekend day, evening or night hours, or full off-shift hours. 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.
Job 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.
This position is an integral member of the site team that is supporting the start-up of the OSUT (Oceanside Single Use Technology) facility in Oceanside. The OSUT is designed to be a state-of-the-art large molecule drug substance facility which supports GMP production for phase 3 clinical trials and commercial products. The OSUT will employ a ballroom design, utilize single-use technology, new analytical techniques and digital manufacturing systems to deliver a best in class bioprocess facility. We are looking for individuals to support this facility who are comfortable with ambiguity, have an entrepreneurial spirit within a GMP environment, have demonstrated strong Pharma Technical Behaviors, and have an agile mindset. Ability to collaborate is crucial as success will be measured as a member of a team, not just as an individual. The team members will work closely with the existing staff in the stainless steel operations as well as with South San Francisco Clinical Supply Center (CSC).
There are 2 primary operations-based groups/areas that support manufacturing for OSUT:
OSUT Process Core Manufacturing - Responsible for the entire process including solution preparation, initial cell bank thaw through to bulk fill.
As a new member of the team, you’ll typically be assigned to one of these two focus areas for operational responsibilities. This will allow you to build capabilities and work on increasingly complex technical assignments, with the potential to rotate into future production areas as you gain experience.
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 fermenters, centrifuges, other harvest systems and protein purification units
Operating and cleaning fixed tank and filtration systems
Operating 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
Preferred 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 and 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
Physical Requirements:
You’ll be on your feet for 8 to 11 hours of the day and will be required to wear company-provided, lab approved steel toe shoes
Our facility is expansive - you may climb multiple flights of stairs daily
You should be able to routinely lift up to 50 pounds
You will work in a clean room environment; you will be required to gown up in the form of hospital scrubs, bunny suits, gloves, hair net, mask, safety glasses, hearing protection
No makeup or jewelry can be worn when working in the clean room environment. Personal electronic devices are not permitted in cleanrooms without approval due to health authority regulation.
You are 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
You may work with hazardous materials and chemicals
Educational Requirements:
High school diploma or equivalent
Preferred - Degree in Life Sciences/Engineering, Associate’s or Biotech certificate from approved program
OSUT Process Core
Primarily Mon-Fri 8 hours/day, except during a planned technical run that will be executed for ~ 6-8 weeks in the late Q3-Q4 timeframe, where the team will shift to a 10-12 hour shift structure.
Note: The Company is committed to complying with the California Consumer Privacy Act ("CCPA") effective January 1, 2020; and all data privacy and laws in the jurisdictions in which it recruits and hires employees. A notice to California Job applicants regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access the notice in an alternative format by contactingNAhr@spectraforce.com
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $22.00/hr.
