Bioprocessing Associate II, MFG DSP

Job Summary

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 MFG18 Cranbury facility. This role will be responsible for procedures and processes associated with the manufacture of Drug Substance.

Responsibilities

• Aid in maintaining a safety-oriented culture and a cGMP compliant work environment at all times
• Assist in facility and equipment start-up activities as needed
• Participate in the Production team to achieve production output targets and quality levels on schedule
• Prepare for shift duties, including checking buffer and material/consumable requirements
• Execute production operations as directed by Standard Operating Procedures and Manufacturing Batch Records
• Support MFG efforts in Continuous Improvement using Lean/Six Sigma tools (Standard Work, TPM, 5S, Method 1, 2 etc.)
• Notify supervisors or senior team members immediately of any deviations from SOPs and/or deviations in the standard production process
• Perform housekeeping duties to maintain facility at a high standard
• Complete all required training in a timely manner and ensure full compliance at all times
• Adhere to all safety policies, procedures, and regulations
• Ensure adherence to GMP requirements, SOPs, and controlled documents
• Be flexible to take on additional tasks and responsibilities as requested by the MFG Supervisor
• Adhere to WuXi’s corporate core values and PROUD culture

Qualifications

• Certificate, Diploma, Degree or equivalent experience in Science/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 advantageous
• Thorough knowledge of current Good Manufacturing Practices (GMP)
• Knowledge of biotech manufacturing processes and their documentation (batch records, SOPs)
• Basic understanding of bioprocessing/biotechnology
• Ability to work within and adapt to complex electronic systems (process automation, SAP, Trackwise investigation system)
• Basic understanding of biopharmaceutical equipment and systems (bioreactors, centrifuges, autoclaves/glass washers, media/buffer systems, purification systems)

Behavioral Competencies

• Excellent communication, interpersonal, and presentation skills
• Collaborative and inclusive approach to work and colleagues
• Excellent problem-solving and troubleshooting skills
• Flexible approach to work and a positive attitude
• Engage cross-functionally with a site-based team
• Autonomous and proactive with initiative to drive actions forward
• Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and customer expectations

Onerous Requirements

• This role may initially be day-based to support onboarding and training but will transition to a permanent shift schedule as per business requirements
• The anticipated base pay range for this position is $28-34/hr

Benefits

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.