MF Lead Operator - Specialty Injectables

Core Hours: Monday - Friday 10:00pm - 6:30am

Purpose and Scope

The Manufacturing Lead Operator - Specialty Injectables supervises and leads processes, including set up and operation of processes related to supporting the Specialty Injectable team, while ensuring that products are made with quality for our patients. Leads may have a primary focus of either Injectables (Sterile Filling/Bulking) or Bulking (Polymer) or both.

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




• Issuance of bulk materials.
• Perform facility cleaning of manufacturing areas as required to maintain a cGMP environment and following Tolmar Standard Operating Procedures.
• Perform final review of processes before the processes can be considered complete.
• Properly perform job duties as a second checker, ensuring all production activities are correctly performed on batch records in accordance with cGMP standards.
• Ensure that product quality adheres to approved specifications.
• Handle hazardous raw materials and cleaning solutions following all applicable safety procedures and policies.
• Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
• Responsible for assembly, disassembly and sanitation of various equipment.
• Train other Manufacturing Operators and Technicians in the Specialty Injectable team to perform job duties related to their position.
• Review and maintain log books, production records, and associated documents to comply with regulatory requirements, GMPs, and Tolmar Standard Operating Procedures.
• Perform visual and physical checks of in-process and finished product as requested.
• Coordinate the daily tasks for Manufacturing Operators and Technicians within assigned process.
• Coordinate materials, staffing and resources to support line operations and changeovers.
• Ensure that employees in assigned process follow safe work practices.
• Perform on the floor, in process reviews of production batch records for accuracy and resolve errors in real time.
• Operate under the guidance of a Manufacturing Supervisor.
• Injectables Specific Responsibilities




• Set up and operate semi-automatic filling equipment used to fill syringes for injectable products in both general manufacturing and sterile manufacturing areas.
• Set-up and operation of equipment connected with Bulking process.
• Assist with equipment steam in place (SIP) on equipment used for sterile bulking processes.
• Perform biological sampling of general manufacturing clean room facilities.
• Perform 100% inspections of pre-filled syringes.
• Assist and support any aseptic process development activities/projects as determined by Specialty Injectable Manager.
• Ability to learn Aseptic technique and work in an aseptic environment.




• Bulking (Polymer) Specific Responsibilities.




• Perform the setup/operation/disassembly and cleaning of production bulking, milling and packaging equipment independent of maintenance personnel oversight.
• Complete cleaning, inspection and lubrication tasks on all Polymer area production equipment.
• Act as liaison between operations and maintenance staff when maintenance requirements are beyond the capability/scope of manufacturing personnel.
• Formulate bulk materials.




• Perform other duties as assigned.

Knowledge, Skills & Abilities

• Mastered knowledge of current Good Manufacturing Procedures (cGMP) as they relate to production packaging activities.
• Ability to stand for extended periods of time (up to 8 hours or more).
• Proficient in Microsoft Office (Excel, Word, and Outlook).
• Ability to maintain focus on detail-oriented, repetitive tasks.
• Excellent verbal and written communication skills.
• Ability to interact with peers and members of other departments in team settings in a professional manner.
• Ability to lead by example and have a proven record of excellence in attendance, dependability and safety.
• Ability to follow and understand written production records and validation protocols.
• Strong understanding of basic math and writing skills to document production activities in batch records and/or log books.
• Ability to keep accurate records and able to perform mathematical calculations.
• Ability to legibly complete required documentation.
• Excellent attention to detail for documentation in production documents and to inspect produced goods within specified requirements.
• Capability to operate on a fast-paced manual assembly line using basic production equipment.
• Ability to receive passing results on an internal inspection qualification for syringe inspection on semi-automated equipment for one syringe type.
• Ability to wear respirator for extended periods of time while working on tasks (up to 4 hours).
• Ability to lift up to 40 lbs.
• Ability to lift arms above shoulder height repetitively for duration of shift while cleaning.
• Ability to provide support as well as direction to Process Development personnel in the area.
• Ability to operate new production equipment with little to no previous experience.
• Ability to lead others in proper aseptic technique and work in an aseptic environment.
• Ability to quickly make decisions and understand the impact on processes and employees.
• Technical ability to assemble and disassemble filing equipment.
• Ability to provide consistent coaching, guidance, development and mentorship to operators and technicians.

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.

Education & Experience

• High school diploma or equivalent required.
• 4 or mor years of experience in a manufacturing role required or have shown the ability to learn/adapt quickly.
• Three or more years of experience in an aseptic (sterile) manufacturing environment preferred.

Working Conditions

• Shift work in a manufacturing and warehouse environment.
• May require overtime and occasional weekend work.

Compensation and Benefits

• Pay: $31.28 per hour
• Shift Differential: $2.50 per hour
• Benefits summary: https://www.tolmar.com/careers/employee-benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.