Bioprocessing Associate ll, MFG USP jobs in United States
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WuXi Biologics · 19 hours ago

Bioprocessing Associate ll, MFG USP

WuXi Biologics is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics. The Bioprocess Associate II role will support the production of biological products, adhering to GMP requirements and ensuring quality standards in the manufacturing process.

BiotechnologyHealth CareManufacturingPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Assist in maintaining a safety orientated Culture, cGMP compliant work environment at all times
Complete all training in a timely manner. Maintain assigned training ensuring full compliance at all times
Adhere fully to all safety policies, procedures, and regulations
Ensure highest Quality & Compliance standards
Perform all duties in accordance with GMP requirements, SOPs, and controlled documents
Assist as a member of the Production team, towards the delivery of production output targets and quality levels on schedule
Carry out all production operations in the assigned area as directed by the relevant Standard Operating Procedures (SOPs) and Batch Records
Report issues identified during routine operations to Senior Team Member and/or Supervisor and perform initial troubleshooting as needed
Immediately notify the Supervisor or Senior Team Member and QA of any deviation from SOPs and/or deviations in the standard production process
Perform housekeeping duties as assigned to maintain facility at a high standard
Able to work in a cross-functional environment to ensure successful delivery of projects
Where necessary assist in Facility and Equipment start up and Validation activities
Provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new equipment as needed
Take part in deviation investigations and process optimization using scientific, engineering, and lean principles
Training and mentoring colleagues in SOPs, process execution and equipment operation as needed
Write, review and revision of area SOPs, Batch Records, Logbooks, On-The-Job Trainings (OJT) as needed
Review Executed Batch Records as needed
Seek opportunities for Continuous Improvement
Will be flexible to take on additional tasks and responsibilities at the discretion of the MFG Senior Bioprocess Associate and Supervisor
Shift work is required. The shift pattern may be varied according to business requirements and will typically require weekend working
Will be flexible to take overtime work and may work during holidays
Will act as a role model for the Manufacturing function and the wider organization in adherence to the WuXi corporate core values and PROUD culture

Qualification

CGMP manufacturingBioprocessing knowledgeBiopharmaceutical equipmentUpstream ManufacturingSOP documentationCommunication skillsProblem solvingTeam collaborationFlexibilitySelf-starter

Required

Certificate, Diploma, Degree or equivalent in Science, Engineering or related field is essential
0-3 years' experience in biopharmaceutical or pharmaceutical cGMP manufacturing
Thorough knowledge of current Good Manufacturing Practices (GMP)
Knowledge of biotech manufacturing processes and their translation into documentation such as batch records and SOPs
Technical knowledge of bioprocessing/biotechnology and Upstream and /or Downstream biologics processes
Ability to work within and adapt to complex electronic systems such process automation, LIMS, SAP, Trackwise investigation system etc
Must be familiar with biopharmaceutical equipment and systems such as bioreactors, centrifuges, autoclaves / glass washers, media/buffer systems, and purification systems
Excellent communication, interpersonal and presentation skills
Collaborative and inclusive approach to work and your colleagues
Excellent problem solving and troubleshooting skills
Flexible approach to work and a positive attitude will be a good fit within the team dynamic
Engage cross functionally in conjunction with a site-based team
Autonomous and a self-starter who will use their initiative to drive actions forward
Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers' expectations

Preferred

Experienced in the Upstream Manufacturing function at a similar size and scale is an advantage

Company

WuXi Biologics

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WuXi Biologics is a open-access technology platform company offering end-to-end solutions to empower organizations to discover and develop.

H1B Sponsorship

WuXi Biologics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (23)
2024 (32)
2023 (22)
2022 (12)
2021 (17)
2020 (1)

Funding

Current Stage
Public Company
Total Funding
unknown
2017-06-13IPO
2017-01-01Series Unknown

Leadership Team

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Jijie Gu, Ph.D.
Executive Vice President & Chief Scientific Officer & Global Head BD&L
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Adrienne Johnson, SPHR
Sr. Human Resources Business Partner
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Company data provided by crunchbase