Manufacturing Technician

2 weeks ago

Berkeley, United States Insight Global Full time

Title: Manufacturing Tech - Cell Therapy

Duration: 2 year contract

Location: Berkeley, CA


POSITION SUMMARY-

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 Therapy, 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.


REQUIREMENTS


- Minimum of BS in science related field is preferred - Transferable skills will be considered. or an equivalent combination of education and experience.

  • Cell Therapy and/ or Stem Cell Experience

- Must have minimum of 1+ years' experience.

- Must be Experienced in cGMP and GDP requirements for pharmaceutical manufacturing.

• Experienced with business IT systems (Delta V, Team, outlooks, SAP etc…)


Exact compensation may vary based on several factors, including skills, experience, and education.


Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

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