Manufacturing Associate II - Upstream

The Manufacturing Upstream Scientist II 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.

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.
• 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.

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.

Preferred Qualifications:

• The preferred candidate would have general working knowledge of 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 a biopharma or biotech manufacturing setting.
• Proficiency in aseptic operations and in-process sampling.
• Experience in supporting cGMP operations and commercial exposure is a plus.

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

• Initial training may be performed on the day shift
• Required Overtime (time-and-a-half pay), holidays, and weekends.

The hourly rate for this position ranges from $33.00 to $38.00 per hour. In addition, Kashiv BioSciences, LLC., offers a short-term incentive opportunity, such as a bonus or performance-based award with this position within the first 12 months. Kashiv BioSciences, LLC., ranges reflect the Company’s good faith estimate of what Kashiv BioSciences, LLC., reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.

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.