Manufacturing Technician Job at Insight Global in Berkeley

Responsible for clinical manufacturing of monoclonal antibodies (mAB) Drug substance within the Cell Culture Technology Center (CCTC). Collaborates closely with biological development (BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensure platform alignment. Responsible for all aspects of clinical manufacturing in the following areas: Cell Expansion, Cell Culture, Purification, Solution Preparation and Weigh/Dispense. Including freezing and put away products.

Responsibilities
-Solution prep: Chemical weighing, Solution/media/buffer preparation, filtration into a holding bins, samples taking and measurement.
-Bag install and un-install, and filter integrity
-Cell culture/Cell expansion: Daily cell expansion, 200L, 2000L bioreactor run monitoring via automated system (Delta V). Bioreactor sample taking and measurement to confirm cell viability, glucose and lactate. Aliquot samples under the biosafety cabinet and put away in freezer including submit to QC.
-Perform harvest clarification system (3M/RC filters install/un-install); clean up post processing
-Operate affinity chromatography via the Aktaready XL to remove impurities including load, wash, elution, generate, and storage.
-Perform low pH Viral inactivation and neutralization
-Operate Anion/Cation exchange chromatography (AEX/CEX) using Cytiva Aktaready gradient to polishing step to remove the impurities. Perform load adjustment by adding acidic or basic solution
-Perform Viral filtration using planova filter.
-Perform ultra filtration/Diafiltration at TFF step including chase, product recovery, bagging, and freezing, filter integrity.
-All data collected must document in batch record
-Sampling each unit operation and submit to QC
-Clean up post run.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

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Required Skills & Experience

Must Haves:
4 + years of Manufacturing Experience:
Hands-on experience working on a manufacturing floor
Strong background in GMP and GDP
Experienced with business IT systems (Delta V, Team, outlooks, SAP etc)
Experience with new product launches and transfers

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.