Job Description

• The Manufacturing Upstream Associate is a hands-on position responsible for manufacturing operations that executing mammalian cell culture processes and producing recombinant proteins for a wide range of mammalian-based biosimilars. Responsible for executing cell culture batches from 50L to 2000L volumes within a current Good Manufacturing Practice (cGMP) environment. Responsibilities such as preparation media/buffers, filtration, aseptic procedures biosafety cabinet and bioreactor operations, and cell removal filtration.
• This position also requires responsibilities such as preparation media/buffers, filtration, aseptic procedures biosafety cabinet and bioreactor operations, and cell removal filtration.

Essential Duties & Responsibilities

Key responsibilities of the position include, but are not limited to –

• Demonstrate a sound knowledge and understanding of cGMP requirements. Adhere to real-time documentation during production run and maintain accurate records/logs.
• Set up, operate, and break down upstream equipment including bioreactors, depth filtration, and disposables.
• Perform upstream processes at multiple scales in a cGMP environment.
• 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.
• Work 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.

Requirements

Position Requirements and 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 work in a team-oriented environment with cross-functional groups.
• Ability to work in a fast-paced environment and handle changing manufacturing demands.
• Proficient in MS Word, Excel, and PowerPoint.
• Excellent written and verbal communication skills. Ability to communicate technical details at all levels, including senior leadership.
• Ability to troubleshoot technical issues and propose short- and long-term solutions.
• Strong time-management skills and the ability to work under demanding timelines.

Preferred Qualifications:

• The preferred candidate would have general working knowledge with disposable bioreactors, filtration, depth filtration, and single use consumable technologies such as bags, tube sets, and manifolds.
• Hands-on experience with mammalian cell culture and/or media preparation tasks in biopharma or biotech manufacturing setting.
• Proficiency in aseptic operations and in-process sampling.
• Experience in supporting cGMP operations and commercial exposure is a plus.

Additional Position Information:

• As a biosimilar company, our schedules are driven by process requirements. The need for support of manufacturing activities may run through weekends or outside of normal business hours.

o Regular office hours: 09:00 AM to 05:30 PM.

o Manufacturing shifts: 12hr non-rotating shifts for 24/7 coverage, including holidays and weekends.

Shift: Non-Rotating 12 Hour shift – (Shift A - 7 am-7 pm) (Shift B - 7 pm-7 am)

• Compensation: These are hourly FTE positions with overtime eligibility and shift differentials for applicable evenings.

* Manufacturing Associate I (0–2 years of biologics manufacturing experience):

o $30–$36 per hour with up to a 5% yearly cash bonus

* Manufacturing Associate II (2–4 years of biologics manufacturing experience):

o $34–$38 per hour with up to a 5% yearly cash bonus

• Kashiv BioSciences can provide sponsorship support for qualified candidates. Please let us know if you currently require sponsorship or may require sponsorship in the future.

• Interviews and employment are conducted onsite at our Piscataway, NJ facility. Candidates should currently reside within a reasonable commuting distance or plan to relocate to the area.

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 and WFI drums on casters with assistance.

· 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 repetitive motion.

Supervisory Responsibility, if any: N/A

This position description is not a complete list of all responsibilities, duties, or skills required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.

Kashiv BioSciences, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Kashiv BioSciences, LLC comply with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation, and training.