Manufacturing Scientist will beresponsible 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.
Manufacturing Scientist Responsibilities:
Responsible for all aspects of clinical manufacturing in the following areas: Cell Expansion, Cell Culture, Purification, Solution Preparation and Weigh/Dispense.
Employee will work seamlessly across all areas.
Ensures all activities are performed to schedule.
Manufactures products in various phases of product life cycles from clinical through 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) coverage to meet business requirements on short notice.
Ability to lift 45 lb.
Manufacturing Scientist Requirements:
BS in science related field is preferred with a minimum of 2 years of 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 preferred.
Experienced in operation of thermo SUM, 200L and 2000 bioreactors, Akta ready XL, Akta ready gradient, and Akta ready Flux XL preferred.
Experienced with business IT systems preferred (Delta V, Team, outlooks, SAP etc...).
Experienced with Microsoft Office and excellent computer skills preferred.