Core Hours Wednesday - Saturday, 5:00 am - 5:30 pm; every other Wednesday off

Purpose and Scope

The Aseptic Lead Operator supervises and leads processes including set-up and operation of processes related to supporting the injectable team, while ensuring that products are made with quality for our patients.

Key Responsibilities Perform job responsibilities in accordance with standard operating procedures (SOPs) and production records with an expectation of "Right the First Time".

Perform job in a clean room environment requiring clean room gowning, including but not limited to: Company-provided Scrubs

Shoe Covers and Sterile Boot Covers

Hairnets (and beard covers as applicable)

Tyvek Coveralls

Gloves

Full-face masks/hoods

Goggles

Chemical Protection PPE Setup and manufacture (bulk, fill, stopper, label, and package) clinical supplies and commercial pharmaceutical products in an aseptic environment in accordance with production batch records.

Set-up and operate semi-automatic filling equipment used to fill syringes for injectable products in both general manufacturing and sterile manufacturing areas.

Perform routine sampling and inspections of pre-filled syringes for injectable products.

Set-up and operate compounding equipment used to produce bulk material for injectable products.

Perform biological sampling of general manufacturing clean room facilities.

Set-up and operate semi-automatic packaging equipment used to package pre-filled syringes.

Document production activities using regulatory controlled documents including production records and log books.

Accurately perform facility cleaning of manufacturing areas as required to maintain a cGMP environment and by TOLMAR Standard Operating Procedures.

Perform visual and physical inspections of in-process and finished product as requested.

Responsible for assembly, disassembly and sanitation of various equipment.

Properly perform job duties as a second-checker, ensuring all production activities are correctly performed per batch production records.

Responsible for quality of product.

Train other Aseptic Operators and Technicians in the Injectable Products team to perform job duties related to their position.

Handle hazardous raw materials and cleaning solutions following all applicable safety procedures and policies.

Formulate bulk materials.

Maintain proper use of aseptic techniques.

Operate under the minimal supervision of a Supervisor.

Perform other duties as assigned. Special Skills and Knowledge Mastered knowledge of current Good Manufacturing Procedures (cGMP).

Ability to stand for extended periods of time (up to 8 hours or more).

Proficient in Microsoft Office (Excel, Word, Outlook).

Ability to maintain focus on detail-oriented, repetitive tasks.

Excellent verbal and written communication skills to interact with Supervisors and colleagues.

Adhere to written production records and validation protocols.

Strong math and writing skills to document production activities in batch records and/or log books.

Excellent attention to detail for documentation in production documents and to compare produced goods against specified requirements.

Capability to operate on a fast-paced manual assembly line using basic production equipment.

Ability to legibly complete required documentation. Core Values

This position is expected to operate within the framework of Tolmar’s Core Values: Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.​

Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.​

Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.

​ Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.​

Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.​ Communication Interact with peers and members of other departments in team settings in a professional manner.

Provide consistent coaching, guidance, development and mentorship to operators. Education & Experience High school diploma or equivalent required.

3 or more years of experience in a GMP manufacturing environment. Additional Requirements Acceptable results on both a quantitative and verbal assessment test.

Valid driver’s license and acceptable motor vehicle record may be required.

Shift work in a manufacturing and warehouse environment.

May require overtime.

Ability to lead by example and have a proven record of excellence in attendance, dependability and safety. Passing results on an internal inspection qualification for syringe inspection on semi-automated equipment for one syringe type. Compensation and Benefits Pay: $ per hour