Manufacturing Associate (ALL LEVELS)

Description:

$2,500 SIGN-ON BONUS

The Manufacturing Associate, is a full-time non-exempt position at Kashiv Biosciences, LLC, in Chicago, IL. This employee will be responsible for the manufacturing of Drug Substance, Drug Product, visual inspection, and Secondary Packaging for clinical and commercial products for human use. Employee employs aseptic techniques while working in controlled and classified environments, some of which require complete aseptic gowning. Must comply with Kashiv policies, procedures (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirements.

Essential Duties & Responsibilities

• Will be assigned to the daily operations, working with:

Weighing and dispensing of material

Operation of Glasswasher and autoclave

Media and buffer preparation

Drug Substance manufacturing

Filtration systems

Aseptic filling of glass vial and pre-fillable syringes.

Visual inspection of glass vial and prefilled syringes

• Responsible to train and follow aseptic practices in ISO 6 area.
• Responsible to participate in media fill operations.
• Responsible for secondary packaging, material issuance and visual inspection.
• Responsible for in-process testing, such as: pH, Conductivity etc.
• Will verify all raw materials and commodities.
• Completes Batch Records and other cGMP documentation accurately and in a timely manner.
• Removes and dispose soiled materials from the manufacturing area.
• Will assure that the manufacturing areas are maintained within the required conditions for clean room manufacturing.
• Will report all nonconformance or events that arise during the shift to the Supervisor.
• Complies with all safety, cGMP and Company policies, practices, and procedures.
• Writes, reviews, and makes recommendations for change to cGMP documentation such as SOPs and Batch Records.
• Assists with new employee training.
• Supports coordination of activities as necessary.

Education:

• Undergraduate with relevant experience in GMP.
• Associate degree in Science, major in Biology, Chemistry or Biotechnology with at least one year of experience in aseptic product manufacturing.
• BS degree in a Biotechnology, Biology or Chemistry with one to three years of experience in pharmaceutical / biotechnology field.
• MS degree in a Biotechnology, Biology or Chemistry with less than two years of experience in pharmaceutical / biotechnology field.

Experience:

• 1 to 3 years of experience in pharmaceutical / biopharmaceutical field.
• Aseptic techniques and clean room manufacturing experience is preferred.

SPECIALIZED KNOWLEDGE AND SKILLS:

Language:

• Basic verbal and written communication skills in English with the ability to understand technical information, procedures, batch records, and other documents in English.
• Excellent interpersonal skills.

Reasoning Skills:

• The candidate should have the ability to operate complex systems and equipment in accordance with current GMPs, SOPs, and safety guidelines under minimum supervision.
• Basic skills for identifying problems and troubleshooting of the equipment and manufacturing processes
• Ability to work independently, within prescribed guidelines, or as a team member and the demonstrated ability to follow detailed directions.

Computer and/or Technical Skills:

• Skills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc.
• Operation and understanding of word processing, spreadsheets, and data management
• Knowledge of GMP and safety requirements.
• Knowledge of biotechnology operations such as:, Aseptic Filtration Systems, Aseptic Sampling, Filter Integrity Testing, Fermentation Process, Inoculation Process, Chromatography Columns, Osmometer, Weigh Scales, etc.

WORK ENVIRONMENT AND PHYSICAL DEMANDS:

General Work Environment:

• Manufacturing clean rooms
• Willing to work in any of the three shifts or rotate Shifts and work weekends as required by the operations.

Noise:

• Standard noise levels.

Standing/Lifting:

• Extended periods of standing and walking while working in the manufacturing areas
• Must be able to lift 25 lbs.

Visual:

• Eye test for prescription safety glasses is required
• No color blindness

Stress:

• High paced demanding environment to meet ambitious project goals.

Travel:

• Limited travel will be required, but not exceed 5%.

Benefits/Perks:

• $2,500 Sign-on bonus
• Medical
• Dental
• Vision
• 401K
• FSA - Commuter/Transit
• Student Loan Assistance
• Monthly Cell Phone Allowance
• Free Parking (Company Paid)
• On-site Gym
• Conveniently located next to the Metra, Green and Red Line
• One block east of the Chicago White Sox Stadium
• < 10 minutes away from Downtown Chicago

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 complies 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.

PI213013196