Bioprocessing Associate II, Downstream Manufacturing

Job Location – Cranbury NJ

Reporting to the Manufacturing Supervisor, Downstream, the Bioprocessing Associate II role will work with the wider Manufacturing teams to support the production of biological products at the MFG
18 Cranbury facility. This role will be responsible for procedures and processes associated with the manufacture of Drug Substance.

• Assist in maintaining a safety orientated Culture, cGMP compliant work environment at all times
• Where necessary assist in Facility and Equipment start up activities.
• Assist as a member of the Production team, towards the delivery of production output targets and quality levels on schedule.
• Assist the preparation work for shift duties of the day, including but not limited to checking buffer and material/consumable requirements.
• Carry out all production operations in the assigned area as directed by the relevant Standard Operating Procedures and Manufacturing Batch Records.
• Support MFG efforts in Continuous Improvement through the use of Lean/Six Sigma tools as part of daily operations (Standard Work, TPM, 5S, Method 1, 2 etc.)
• Immediately notify the Supervisor or Senior Team Member 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.
• 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
• Will be flexible to take on additional tasks and responsibilities at the discretion of the MFG Supervisor.
• Adherence to the WuXi corporate core values and PROUD culture

• Certificate, Diploma, Degree or equivalent experience in Scientific Engineering, or related field is essential
• 0-2 years' experience in biopharmaceutical cGMP manufacturing
• Direct experience in biopharmaceutical manufacturing and/or clinical phase manufacturing 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
• Basic understanding of bioprocessing/biotechnology
• Ability to work within and adapt to complex electronic systems such process automation, SAP and Trackwise investigation system.
• Basic understanding of 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
• This role may initially be day based to support onboarding and training but will migrate to a permanent shift schedule as per business requirement

The anticipated base pay range for this position is $28-33hr

WuXi Biologics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.