Biopharmaceutical Manufacturing Production Specialist

4 days ago

Berkeley, United States Randstad Life Sciences US Full time

Job Title: Manufacturing Production Specialist

Location: Berkeley, CA 94710

Schedule: 1st shift (6am-3pm), 2nd shift (1-10pm), 3rd shift (9:30pm-6:30am)

Position Type: 1 yr. contract through 08/25/2025; potential for extension


Multiple openings for Manufacturing Production Specialists to work with a multinational, biopharmaceutical company on their 46 acre biologics manufacturing campus in Berkeley, CA. This role is supporting clinical production and will perform cell culture/expansion and purification.


Position Summary: 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.


Essential Duties and Responsibilities:

  • Prepares process equipment (including but not limited to Bioreactors & ancillary equipment, Stainless Steel tanks, Pressure Transmitters, Flow Meters, Aggregate traps, Harvest discards, Transfer lines (buffers, cTCF), Hoses and small parts.
  • Cleans and Sterilizes equipment using appropriate CIP (Clean-In-Place), SIP (Steam-InPlace) procedures.
  • Performs daily or routine process operations in the cell culture and purification of biotech and biological products (Kovaltry, Kogenate, and Jivi). Operates equipment for these processes including:
  • Inoculates and monitors bioreactors.
  • Processes cTCF material to Continuous Cell Separation (CCS).
  • Operates Chromatography, MAEF, MAVF and TFF skids.
  • Processes MAEF material using closed thaw process, step elution chromatography,
  • Membrane Absorber and filter clearance technology, and gradient controlled SP column separation techniques.
  • Operates 50L, 200L and 1000L collection bag technology to ensure robust collection, mixing and dilution of products.
  • Performs PEGylation of JIVI in process material using TFF technology.
  • Operates automated bagging systems.
  • Blast Freezes product for storage.
  • Dispenses chemicals and formulate solutions.
  • Prepares acids and bases as necessary.
  • Performs aseptic operations.
  • Takes, analyzes and submits samples as required throughout the process.
  • Monitors and controls operation with computer control systems.
  • Completes all routine check sheets.
  • Cleans equipment and maintains clean and orderly production facilities.
  • Performs in-depth troubleshooting and root cause analysis of Kovaltry, Kogenate, and Jivi equipment and process failures.
  • Contributes to continuous improvement opportunities.
  • Performs all operations in compliance with cGMP.
  • Performs other related duties as assigned.


Qualifications:

  • BS in science related field is preferred.
  • Requires completion of two-years’ college science courses in (e.g. biology, chemistry, biochemistry, or microbiology) or a certificate from an accredited bio-technology academy.
  • Relevant bio-tech industry experience in some or all of the following is preferred, and may be considered in lieu of some or all of the educational requirements above
  • Experienced in cGMP and GDP requirements for pharmaceutical manufacturing.
  • Cell Culture bioreactor system assembly and use, including control of gas supply to bioreactor, Micro-sparger assembly, Anti-Foam Emulsion system. Ability to troubleshoot and control processes.
  • Continuous Cells Separation equipment preparation and process/controls.
  • Membrane Absorption Chromatography process (e.g. Membrane Absorption process, Buffer and NaOH supply, cTCF supply, Capsule preparation, Inline dilution and Temperature controls).
  • Basic knowledge of protein chemistry and purification systems such as anion, cation, and immunoaffinity chromatography.
  • Membrane Absorber technology, viral removal techniques and tangential flow filtration technology. Large scale chromatography, TFF technology.
  • Familiarity with cGMP’s and applicable agency regulations
  • Transferable skills will be considered. or an equivalent combination of education and experience.
  • Must be able to change shift schedule based on business and process needs.
  • Must provide off-hour (night and weekend including holiday) coverage to meet business requirements on short notice.
  • Ability to lift 45 lb.
  • Independent thinking and decision making.
  • Able to make logical decisions independently for multiple process work streams with limited information or supervision available.
  • Works with highest level of flexibility.
  • Responds easily to last minute changes to production schedule.


Preferred Skills and Experience:

  • Experienced with data integrity, regulatory, requirements for pharmaceutical manufacturing.
  • Experienced in operation of thermo SUM, 200L and 2000 bioreactors, Akta ready XL, Akta ready gradient, and Akta ready Flux XL.
  • Experienced with business IT systems (Delta V, Team, outlooks, SAP etc…)
  • Experienced with Microsoft Office. Excellent computer skills.

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