Downstream Manufacturing Scientist I (Associate I)

Essential Duties & Responsibilities

• 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.

Material & Inventory Management

• 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.

Qualifications

Minimum Qualifications:

• 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.

Preferred Qualifications:

• 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.

Additional Position Information

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.

Work Environment & Physical Demands

General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines.

General Work Environment: Wear appropriate PPE to work in cleanrooms and/or laboratories that are adequately lit, ventilated and temperature controlled. Occasional desk / computer work (reading, editing, writing documents) as required. Potential for chemical odor and dust exists.

Standing/Lifting: 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.