Primary Talent Partners has a contract opportunity with a large biopharmaceutical client of ours in Berkley, CA
Duration:
6-months with possibility of extension or conversion
POSITION SUMMARY
Responsible for clinical manufacturing of monoclonal antibodies (mAB) Drug substance within the Cell Culture Technology Center (CCTC). Collaborates closely with biological development (Client) and Manufacturing Science and Technology (MSAT) for new product introductions and ensure platform alignment.
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 putting away products.
Employees will move with the process and work seamlessly across all areas.
Ensures all activities are performed to schedule.
Manufacturing 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 feedback to handle and troubleshoot 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 always promotes safe behaviors.
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.
EDUCATION/EXPERIENCE
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.
SKILL 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 the 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.
Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at
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