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Form of workJob Description
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.
Job Title: Manufacturing Technician (Expert)-Production Infrastruct-PROD-CS
Location: Berkeley, CA 94710
Duration: 5 Months
Job Type: Contract
Work Type: Onsite
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.
