Manufacturing Associate I - Downstream

• Demonstrate a sound knowledge and understanding of cGMP requirements. Adhere to real-time documentation during production run and maintain accurate records/logs.
• Setup, operate, and break down downstream equipment including chromatography columns, controllers, and TFF systems.
• Perform downstream process at multiple scales in a cGMP environment, column packing, process troubleshooting and data analysis.
• Perform calculations for processing, weighing materials, chemical and reagent additions.
• Uses programs to collect and evaluate operating data to conduct online adjustments to products, instruments, or equipment.
• Works with other teams and outside vendors to resolve technical issues as well as maintenance of production equipment.
• Follow all GMP instructions in the manufacturing area and take responsibility / ownership of environmental health and safety policies.
• Coordinate the conduction of investigations and corrections for issues found during the batch execution process.
• Comply with all company policies and standards. Ensuring all operations comply with cGMP, safety, and data integrity standards.
• Performs other functions as required or assigned.
• Revision of solution preparation batch records, SOPs, Protocols and logbooks.
Providing support during quality audits and regulatory inspections.

• Order, maintain, track, and staging of raw materials and consumables for upstream, downstream, and media/buffer preparation processes.
• Perform label verification, receipt checks, and electronic inventory updates.
• Coordinate with warehouse and planning teams for material readiness.
• Managing material inventory inside cleanroom areas.

• Education: High school diploma or equivalent required. Bachelor’s degree preferred.
• Experience in a manufacturing environment or 1-2 years of relevant experience preferred.
• Familiarity with safety protocols/procedures
• Ability to understand and adhere to written and verbal instructions. Excellent written and verbal communication skills. Ability to communicate technical details at all levels, including senior leadership
• Ability to work well with a wide range of people from other groups in a team-oriented environment with cross-functional groups.
• Ability to learn to properly use various hand and electrical tools.
• Ability to work in a fast-paced environment and handle changing manufacturing demands.
• Proficient in MS Word, Excel, and PowerPoint.
• Ability to troubleshoot technical issues and propose short- and long-term solutions.
• Strong time-management skills and the ability to work under demanding timelines.
• Work in a team environment and be able to work independently with minimum supervision.
Ability to learn to properly use various hand and electrical tools.

• The preferred candidate would have general working knowledge of AKTA purification skids or similar, tangential flow filtration (TFF), columns, and single-use consumable technologies such as bags, tube sets, columns, and process manifolds
• Previous hands-on experience working with mammalian cell lines in a GMP and aseptic commercial manufacturing setting with biopharma or biotech.
Proficiency in aseptic operations and in-process sampling.

• As a biologics/biosimilars company, our schedules are driven by process requirements.
• Manufacturing Operations is 12hr shifts for 24/7 coverage (2-2-3 work schedule), including holidays and weekends. Shift A (day shift): 7:00 AM to 7:00 PM EST and Shift B (night shift): 7:00 PM to 7:00 AM EST.
• Initial training may be performed on the day shift
• Required Overtime (time-and-a-half pay), holidays, and weekends.
• During the interview process, please let us know whether you have a preference for the day shift, the night shift, or are open to both.
• Compensation: These are hourly FTE positions with overtime eligibility and shift differentials for applicable evenings.
Interviews and employment are conducted onsite at our Piscataway, NJ facility.

• Occasional desk / computer work (reading, editing, writing documents) as required.
Potential for chemical odor and dust exists.

• Must be able to move around the facility to reach various equipment.
• Physical lifting and shifting required for pushing and pulling pre-made buffer containers
• Must be able to lift at least 25 lbs. to lift weights onto scale for daily scale verification
• Must be able to stand for long periods of time. Occasional bending, squatting, kneeling, stooping, pushing, pulling, reaching, and walking.
• Frequent lifting/moving of approximately 25-50 lbs.
• Frequent transporting approximately 100-250 lbs. buffer drums on casters with assistance.
Frequent repetitive motion.

• 
  

At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.