Manufacturing technician/Cell culture technician

2 weeks ago

Berkeley, United States TekWissen ® Full time

Job Title: Manufacturing Technician (Expert)-Production Infrastruct-PROD-CS

Location: Berkeley, CA 94710

Duration: 5 Months

Job Type: Contract

Work Type: Onsite

Pay Rate: $33.96-33.96/Hourly/W2


Overview:

TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. This client is a German multinational Pharmaceutical and biotechnology company and one of the largest pharmaceutical companies in the world, headquartered in Leverkusen, and areas of business include pharmaceuticals; consumer healthcare products, agricultural chemicals, seeds and biotechnology products.


Description:

  • 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.

POSITION DUTIES & RESPONSIBILITIES

  • 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.
  • Employee will move with the process and work seamlessly across all areas.
  • Ensures all activities are performed to schedule.
  • Manufactures products in various phases of product life cycles from clinical thru launch.
  • Clearly understands, communicates, and manages differences in terms of documentation, sample handling, automation and cGMPs etc. for different phases of product life cycle.
  • Provide feedbacks to handles and troubleshoots single use technology (SUT) from end to end in manufacturing process.
  • Works cross functionally to ensure process is controlled and issues are escalated and investigated.
  • Redlines and reviews controlled documents for various equipment/processes.
  • Effectively employs all methods of communication (oral, written, presentation) to ensure knowledge and information transfer across shifts, to management, and cross functionally.
  • Raises and supports investigation of deviations.
  • Participates in safety investigations for CCTC and promotes safe behaviors at all times.
  • 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.

REQUIREMENTS/PREFERENCES

Education Requirement(s):

  • Minimum of BS in science related field is preferred
  • Must have minimum of 2+ years' experience.
  • Transferable skills will be considered. or an equivalent combination of education and experience.

Skill & Competency Requirements:

  • Demonstrates strong tendency towards 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.
  • Must be Experienced in cGMP and GDP requirements for pharmaceutical manufacturing.

Preferences:

  • 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.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.

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