Bioprocess Manufacturing Technician

Lancesoft

Oceanside, CA

JOB DETAILS
SALARY
$23
LOCATION
Oceanside, CA
POSTED
30+ days ago
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.

As a new member of the team, you’ll typically be assigned to one of the three production areas. 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 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
We have a variety of 12- and 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:
12 hr Day Shift, 6: 00 am –7: 00 pm,
Work: Sunday -Tuesday plus every other Wednesday
Work: Wednesday –Friday plus every other Saturday
10 hr Day Shift, 6: 00 am –4: 30 pm
Sunday - Wednesday
Wednesday - Saturday
10 hr Swing Shift, 3: 30 pm -2: 00 am
Sunday - Wednesday
Wednesday - Saturday
12 hr Night Shift, 6: 00 pm -7: 00 am
Sunday-Tuesday plus every other Saturday
Wednesday –Friday plus every other Saturday
On boarding 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

About the Company

L

Lancesoft

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2000
WEBSITE
http://www.lancesoft.com/