Bioprocessing Associate II, MFG DSP

WuXi Biologics; Cranbury Township (NJ); On-site; USD 30,000 - 47,000; Full time

Job summary

WuXi Biologics in Cranbury, NJ, is seeking a Bioprocessing Associate II to support downstream manufacturing and drug substance production at the MFG18 site. You will work with a team to ensure GMP, quality, and safety across operations.

Reporting to the Manufacturing Supervisor, you will assist with training, equipment start-up, and batch record documentation while contributing to continuous improvement and lean initiatives in a fast-paced biopharma environment.

Qualifications

• Certificate, Diploma, Degree or equivalent in Science/Engineering or related field.
• 0-2 years' experience in biopharmaceutical cGMP manufacturing.
• Experience in biopharmaceutical manufacturing is an advantage.
• GMP knowledge and experience with batch records and SOPs.
• Ability to work with SAP and TrackWise systems.
• Basic understanding of bioprocessing/biotechnology.
• Knowledge of biotech manufacturing processes and related documentation.

Responsibilities

• Support production of biological products at MFG18 Cranbury facility.
• Assist with safety culture and cGMP compliance.
• Support start-up activities for facilities and equipment.
• Participate in production tasks to meet output targets and quality.
• Prepare for shifts: check buffers and material requirements.
• Perform operations per SOPs and batch records.
• Support continuous improvement with Lean/Six Sigma tools.
• Escalate deviations to supervisor and maintain safety standards.
• Maintain housekeeping and training compliance.

Skills

Communication

Interpersonal skills

Problem solving

Team collaboration

Initiative

Ethics/compliance

Education

Science/Engineering degree

Tools

SAP

TrackWise

Job description

Job Title - Bioprocessing Associate ll, MFG DSP

Job Location – Cranbury NJ

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’ achievements are a direct result of the efforts made by our PROUD culture of Passion, Reward, Opportunity, Unity and Determination. WuXi Biologics offers exciting job opportunities and careers around the globe. We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies

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

• 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

Qualifications

• Certificate, Diploma, Degree or equivalent experience in Sciencem Engineering, or related field is essential
• 0-2 years' experience in biopharmaceuical cGMP manufacturng
• Direct experience in biopharmaceutical manufacturing and/or clinical phase manufactuirng 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.

Behavioral Competencies

• 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

Onerous Requirements

• 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 $22-34hr

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