Biopharmaceutical Manufacturing Production Specialist

4 weeks ago

Berkeley, United States Randstad Life Sciences US Full time

Job Title: Manufacturing Production Specialist

Location: Berkeley, CA 94710

Schedule: 1st shift (6am-3pm), 2nd shift (1-10pm), 3rd shift (9:30pm-6:30am)

Tue.-Sat. or Sun.-Thurs.

Position Type: 5 mos. contract through Q3; potential for extension


Multiple openings for five (5) Manufacturing Production Specialists to work with a multinational, biopharmaceutical company on their 46 acre biologics manufacturing campus in Berkeley, CA. This role is supporting new CDMO business as well as internal new product pipelines and will perform cell culture/expansion and purification operations.


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.


Essential Duties and 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 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.


Qualifications:

  • BS in science related field is preferred. MS or PhD in science related field with no prior industry experience.
  • Must have min. of two (2) years' experience.
  • Transferable skills will be considered. or an equivalent combination of education and experience.
  • 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.
  • 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.


Preferences:

  • Experienced with data integrity, regulatory, and cGMP 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.

  • Biopharmaceutical Manufacturing Production Specialist

    2 days ago

    Berkeley, United States Randstad Life Sciences US Full time

    Job Title: Manufacturing Production Specialist Location: Berkeley, CA 94710 Schedule: 1st shift (6am-3pm), 2nd shift (1-10pm), 3rd shift (9:30pm-6:30am) Tue.-Sat. or Sun.-Thurs. Position Type: 5 mos. contract through Q3; potential for extension Multiple openings for five (5) Manufacturing Production Specialists to work with a multinational,...

  • Manufacturing Technician

    2 weeks ago

    Berkeley, United States TekWissen LLC Full time

    Job DescriptionJob DescriptionOverview: 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...

  • Manufacturing Technician

    4 days ago

    Berkeley, United States Planet Pharma Full time

    12-Month Contract $26-$35/Hour ***Compensation within this range will be commensurate with level of experience***DEPARTMENT/TEAM DESCRIPTION:Center for Cell Culture Technology (CCTC), B69POSITION SUMMARY:Responsible for clinical manufacturing of cell therapy DS/DP within the Cell Culture Technology Center (CCTC). Collaborates closely with biological...

  • Manufacturing Technician

    4 days ago

    Berkeley, United States Planet Pharma Full time

    12-Month Contract $26-$35/Hour ***Compensation within this range will be commensurate with level of experience***DEPARTMENT/TEAM DESCRIPTION:Center for Cell Culture Technology (CCTC), B69POSITION SUMMARY:Responsible for clinical manufacturing of cell therapy DS/DP within the Cell Culture Technology Center (CCTC). Collaborates closely with biological...

  • Manufacturing Technician

    4 weeks ago

    Berkeley, United States Planet Pharma Full time

    Manufacturing Technician (Expert)Berkeley, CA6 month contractJob Description:Analyzes inventory transactions to ensure accuracy.Evaluates inventory levels.Coordinates material requirements and delegates work orders to manufacturing.Handles production planning, quality management and process reengineering.7+ Years of Experience required

  • Bioprocess Manufacturing Technician

    7 days ago

    Berkeley, United States TekWissen ® Full time

    Job Title: Manufacturing technician/Cell culture technicianLocation: Berkeley, CA 94710 Duration: 12 Months Job Type: Contract Work Type: Onsite Pay Rate: $30-35/Hourly/W2Overview: 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...

  • Bioprocess Manufacturing Technician

    6 days ago

    Berkeley, United States TekWissen ® Full time

    Job Title: Manufacturing technician/Cell culture technicianLocation: Berkeley, CA 94710 Duration: 12 Months Job Type: Contract Work Type: Onsite Pay Rate: $30-35/Hourly/W2Overview: 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...

  • Manufacturing Engineer 3

    3 weeks ago

    Berkeley, United States Boeing Future of Flight Full time

    Develops and implements production and tooling methodologies. Participates on Integrated Product Teams (IPTs) to integrate technical solutions across multiple disciplines. Develops, identifies and implements conceptual designs and maintains the program architecture for build. Leads and implements manufacturing plans. Conducts producibility and variation...

  • Production Coordinator

    2 days ago

    Berkeley, United States Lighthouse for the Blind Full time

    Job DetailsJob Location Fleischer - Berkeley, MO Job Category Entry Level Description If you're seeking a new opportunity to work with an organization focused on future growth, strategy and innovation, look no further! LHB Industries is currently seeking a Production Coordinator with previous manufacturing experience to join our team. This is a fantastic...

  • Manufacturing technician/Cell culture technician

    5 hours ago

    Berkeley, United States TekWissen ® Full time

    Job Title: Manufacturing Technician (Expert)-Production Infrastruct-PROD-CS Location: Berkeley, CA 94710 Duration: 5 Months Job Type: Contract Work Type: Onsite Pay Rate: $33.96-33.96/Hourly/W2Overview: TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. This client is a German multinational...

  • Product Development Engineer

    3 days ago

    Berkeley, United States Gravitas Medical Full time

    JOB TITLE: Product Development EngineerCOMPANY DESCRIPTIONGravitas Medical is revolutionizing enteral feeding with an FDA cleared smart nasogastric feeding system. See for more information.POSITION DESCRIPTIONThe Product Development Engineering position supports all product development engineering activities including but not limited to design, testing and...

  • Product Development Engineer

    4 days ago

    Berkeley, United States Gravitas Medical Full time

    JOB TITLE: Product Development EngineerCOMPANY DESCRIPTIONGravitas Medical is revolutionizing enteral feeding with an FDA cleared smart nasogastric feeding system. See for more information.POSITION DESCRIPTIONThe Product Development Engineering position supports all product development engineering activities including but not limited to design, testing and...

  • Production Maintenance Technician

    7 days ago

    Berkeley, United States GU Energy Full time

    GU Energy Labs is a family-owned market-leading global sports nutrition brand, and we are looking for a **Maintenance Technician** to join our team! This position diagnoses equipment malfunctions and makes repairs and adjustments as needed. Experience with horizontal form seal pouching line or similar food manufacturing equipment is required. This position...

  • Production Maintenance Technician

    4 weeks ago

    Berkeley, United States GU Energy Full time

    Job DescriptionJob DescriptionSalary: $25 - $35/hrGU Energy Labs is a family-owned market-leading global sports nutrition brand, and we are looking for a Maintenance Technician to join our team!This position diagnoses equipment malfunctions and makes repairs and adjustments as needed. Experience with horizontal form seal pouching line or similar food...

  • Sales Engineer

    1 week ago

    Berkeley, United States K I Industries Full time

    Sales Engineer at KI Industries Inc. - Berkeley, IL About KI Industries Inc. KI Industries, founded in 1964, specializes in designing and manufacturing decorative plastic and die-cast components for the automotive and appliance industry. Our attention to aesthetics and technical expertise creates components that our customers know will provide their end...

  • LIMS Master Data Specialist

    2 weeks ago

    Berkeley, United States Kelly Science, Engineering, Technology & Telecom Full time

    Description:Responsible for all activities around maintaining LIMS / LabVantage / MODA master data tasks and responsibilities:with LIMS / LabVantage / MODA Admins to put together and route.or review an execution and close Master Data change requests for LabVantage LIMS systems.supporting documentation to support change requests including, but not limited to...

  • LIMS Master Data Specialist

    2 weeks ago

    Berkeley, United States Kelly Science, Engineering, Technology & Telecom Full time

    Description:Responsible for all activities around maintaining LIMS / LabVantage / MODA master data tasks and responsibilities:with LIMS / LabVantage / MODA Admins to put together and route.or review an execution and close Master Data change requests for LabVantage LIMS systems.supporting documentation to support change requests including, but not limited to...

  • Financial Planning

    4 weeks ago

    Berkeley, United States KI Industries Full time

    Job DescriptionJob DescriptionFinancial Planning and Analysis Manager at KI Industries Inc. – Berkeley, ILAbout KI Industries Inc.KI Industries, founded in 1964, specializes in the design and manufacture of decorative plastic and die cast components for the automotive and appliance industry. Our attention to aesthetics and technical expertise creates...

  • Financial Planning

    2 weeks ago

    Berkeley, United States K I Industries Full time

    Financial Planning and Analysis Manager at KI Industries Inc. - Berkeley, IL About KI Industries Inc. KI Industries, founded in 1964, specializes in the design and manufacture of decorative plastic and die cast components for the automotive and appliance industry. Our attention to aesthetics and technical expertise creates components that our customers know...

  • Sr. Environmental Engineer

    7 days ago

    Berkeley, United States Yorke Engineering LLC Full time

    Join Yorke Engineering, LLC, an Environmental Consulting leader in California, while we implement Environmental Engineering and Compliance solutions for clients throughout California. Our mission is to solve environmental compliance problems for industrial and governmental/infrastructure facilities. We are a growing and dynamic organization of highly...