- Responsible for clinical manufacturing of cell therapy DS/DP 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, Differentiation, Filling, Visual Inspection, Solution Preparation and Weigh/Dispense.
- 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.
- Minimum of BS in science related field is preferred
- Must have a minimum of 2+ years' experience.
- Transferable skills will be considered. or an equivalent combination of education and experience.
- 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.
- Experienced with data integrity, regulatory, requirements for pharmaceutical manufacturing.
- Experienced in operation of bag filler, pumps, BSCs, welders/sealers, environmental monitoring equipment.
- Experienced with business IT systems (Delta V, SAP etc...)
- Experienced with Microsoft Office. Excellent computer skills.
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Manufacturing technician/Cell culture technician - Berkeley, United States - TekWissen ®
Description
Job Title: Manufacturing technician/Cell culture technician
Location: Berkeley, CA 94710
Duration: 12 Months
Job Type: Contract
Work Type: Onsite
Pay Rate: $ /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:
POSITION DUTIES & RESPONSIBILITIES
REQUIREMENTS/PREFERENCES
Education Requirement(s):
Skill & Competency Requirements:
Preferences:
TekWissen Group is an equal opportunity employer supporting workforce diversity.
