What are the responsibilities and job description for the Manufacturing Technician (Expert) - Production Infra position at bayer?
DEPARTMENT/TEAM DESCRIPTION-
Center for Cell Culture Technology (CCTC), B69
POSITION SUMMARY-
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.
POSITION DUTIES & RESPONSIBILITIES
? 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.
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 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.
Travel Requirements: (if applicable)
? Not required.
?Why is this position open? Growth on the team, turn over, skills gap?
1 additional position is needed to support the CT Mod Clinical Production Campaign.
? Location of this role site or remote?
The position requires to be in person at Berkeley site, CA
? What is a day like in this role? What 3-5 responsibilities will occupy their time?
. Solution prep: Chemical weighing, Solution/media/buffer preparation, filtration into a holding bags, samples taking and measurement.
. Bag install and un-install, and filter integrity
. Cell culture/Cell expansion: Daily cell expansion. Aliquot samples under the biosafety cabinet and put away in freezer including submit to QC.
. Environmental Monitoring:
. Perform personnel monitoring, surface sampling, active air, and passive sampling for open operations.. Sampling each unit operation and submit to QC
.Support visual inspection
