Manufacturing Upstream Associate I/II

About the role

The Manufacturing Upstream Associate is a hands-on position responsible for executing mammalian cell culture processes and producing recombinant proteins for a wide range of mammalian-based biosimilars. This position operates within a current Good Manufacturing Practice (cGMP) environment.

Responsibilities

• Execute cell culture batches from 50L to 2000L volumes.
• Prepare media/buffers, filtration, and perform aseptic procedures in a biosafety cabinet and bioreactor operations.
• Perform calculations for processing, weighing materials, chemical and reagent additions.
• Use 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 and maintain production equipment.
• Follow all GMP instructions in the manufacturing area and ensure compliance with environmental health and safety policies.
• Coordinate the conduct 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.
• Revise solution preparation batch records, SOPs, protocols, and logbooks.
• Support during quality audits and regulatory inspections.

Requirements

• Education: High school diploma or equivalent required. Bachelor’s degree preferred.
• Experience: 1-2 years of relevant experience preferred.
• Skills: Familiarity with safety protocols/procedures, ability to work in a team-oriented environment, proficiency in MS Word, Excel, and PowerPoint, excellent written and verbal communication skills, ability to communicate technical details, troubleshooting technical issues, strong time-management skills, and ability to work under demanding timelines.

Preferred Qualifications

• General working knowledge with disposable bioreactors, filtration, depth filtration, and single use consumable technologies.
• Hands-on experience with mammalian cell culture and/or media preparation tasks in biopharma or biotech manufacturing settings.
• Proficiency in aseptic operations and in-process sampling.
• Experience in supporting cGMP operations and commercial exposure is a plus.

Additional Position Information

• Schedules: Regular office hours: 09:00 AM to 05:30 PM. Manufacturing shifts: 12hr non-rotating shifts for 24/7 coverage, including holidays and weekends.
• Compensation: These are hourly FTE positions with overtime eligibility and shift differentials for applicable evenings. Manufacturing Associate I: $30–$36 per hour with up to a 5% yearly cash bonus. Manufacturing Associate II: $34–$38 per hour with up to a 5% yearly cash bonus.
• Sponsorship Support: Kashiv BioSciences can provide sponsorship support for qualified candidates.

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

N/A