Bioprocessing Associate ll, MFG USP

Bioprocessing Associate I/II, MFG USP

Location: Cranbury, NJ

Company: 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 from concept to commercial manufacturing. WuXi Biologics employs over 12,000 people and provides services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies.

Reporting to the Upstream Manufacturing Supervisor, the Bioprocess Associate I/II role will work with the wider Manufacturing teams to support the production of biological products at the Cranbury, NJ facility. This role will be responsible for procedures and processes associated with the manufacture of clinical Drug Substance.

• 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 revise 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.

• Certificate, Diploma, Degree or equivalent in Science, Engineering or related field is essential.
• 0–3 years’ experience in biopharmaceutical or pharmaceutical cGMP manufacturing.
• Experienced in the Upstream Manufacturing function at a similar size and scale is an advantage.
• 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…