Manufacturing Operations Supervisor

Medix / Kashiv Biosciences

Location: Chicago

Pay Rate: $40+ / Hour

Position Summary:

The Supervisor, Manufacturing Operations (Injectable), is a regular employee in a full-time non-exempt

position at Kashiv Biosciences, LLC, in Chicago, IL. This employee is the shift leader for the

manufacturing operation of Fill finish manufacturing or visual inspection and finished product and is

responsible for producing high quality products in accordance with regulatory requirements to achieve

the operations production plan. This employee must maintain effective employee relationships,

compliance to cGMP and other regulatory and SOP requirements, as well as environmental, health and

safety obligations and company policies.

Essential Duties and Responsibilities:

• A working supervisor position is shift lead.
• Participate in all drug substance related manufacturing process. Perform (Where needed) and review the process to ensure compliance with the requirements listed in respective batch record.
• Provides daily supervision on the floor to personnel in the efficient use of equipment and materials to produce quality products under cGMP in accordance with the production plan for ISO7, and ISO8 manufacturing area as well as Visual inspection and finished product area.
• Provides coaching, counseling, development, discipline and recognition of direct staff, including performing annual performance reviews.
• Responsible for maintaining alignment with department direction, goals and objectives.
• Promotes the use of safe work practices during all production and ensures all external and company policies and EHS standards are met daily.
• Responsible for training personnel on equipment, processes and Standard Operating Procedures (SOPs).
• Trains and develops personnel, develops and maintains packaging schedules, and manages within the department budget.
• Ensures that projects are completed on schedule per established procedures.
• Participate in execution of qualification and validation activities.
• Participate in process related investigation(s) and implement CAPA derived from investigation outcome in timely manner.

Job Description:

• Author and reviews SOPs and other documents to ensure integration of cGMPs and improve process efficiency.
• Works collaboratively to ensure flow of product, sharing of best practices and lean behaviors.
• Performs process monitoring, including use of databases, documents and/or spreadsheets to support business reporting requirements.
• Performs ongoing operational tasks of organization unit, actively assists, or provides direction to subordinates as required.
• Responsible for final review of completed documentation per compliance standards and establish
• Timelines.
• Investigates and resolve problems, identifying root cause, and proposing process improvements through clear communication to senior management.
• Participation and/or leadership role in multi-functional project teams as necessary.
• Other tasks as requested by management.

Position Requirements and Qualifications:

• Bachelor's degree, in engineering, pharmaceutical, related life science and at least 5 years of experience; Master's degree, in engineering, pharmaceutical, related life science and at least 2 years of experience
• Aseptic Processing experience preferred
• PFS manual visual inspection experience
• Finished Product packaging experience with Serialization preferred

• Prior aseptic process execution and supervisory experience is strongly preferred
• Previous biotechnology experience in a pharmaceutical environment is preferred
• Knowledge of FDA cGMPs
• Strong technical writing skills with ability to author SOPs and deviations
• Competent with MS Office Applications
• Knowledge of current Code of the Federal Regulations (CFRs) and current Good Manufacturing
• Practices (cGMPs)

Medix is acting as an Employment Agency in relation to this vacancy.