Production Supervisor Specialty Injectables

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

Purpose and Scope

The Specialty Injectable Supervisor performs activities related to supporting the Specialty Injectable team, while ensuring that products are made with quality for our patients. Supervises and coordinates shift production activities and related staffing, scheduling and planning in manufacturing. Specialty Injectables includes sterile filling/bulking and non-sterile bulking (Polymer).

Key Responsibilities

• Demonstrates a high degree of honesty, initiative, integrity, drive, reliability and trustworthiness.
• Actively models and fosters a positive, respectful, and harassment-free work environment for all employees.
• Actively supervises and manages the performance of hourly manufacturing employees in the aseptic manufacturing group.
• Conducts interviews and participates in making hiring decisions for hourly employees.
• Ensures open and transparent communication to the hourly employees about company priorities, policies and general company announcements.
• Identifies, proposes and supports implementation of process improvements and optimizations of the aseptic manufacturing processes.
• Communicates and sets daily production priorities with Process Leads and hourly employees.
• Responsible for the coordination of various processing steps for specialty injectable products to ensure critical time limits are adhered to and product quality meets specifications.
• Accurately evaluates and reviews technical process data and provides approval for further processing if process parameters are met.
• Monitors and tracks in-process and sterile hold times throughout critical manufacturing processes to ensure time limits are met.
• Oversees the work of the Specialty Injectable Leads and Specialty Injectable Operators who conducts or coordinates the in-process training, including line orientation and risk review, of all new team members.
• Responsible for monitoring the training progress and readiness to work independently for all direct reports.
• Ensures production team adheres to all quality standards and specifications.
• Creates, revises and implements Standard Operating Procedures (SOPs) and Production Batch Records.
• Performs Batch Record review, including prioritization, reviewing corrections, and following up to ensure timely completion.
• Performs transactions in the Inventory Control System (Deacom) on a timely basis.
• Performs investigations and CAPA implementations for non-conforming events.
• Pre-approves expiration dates on batch records prior to manufacturing.
• Proactively and effectively manages performance of their team.
• Conducts employee performance evaluations.
• Reviews and approves direct report timesheets.
• Performs other related duties as assigned.

Special Skills and Knowledge

• Mastered knowledge of current Good Manufacturing Procedures (cGMP) as they relate to sterile injectable manufacturing.
• Ability to stand for extended periods of time (up to 8 hours or more).
• Proficient in Microsoft Office (Excel, Word, Outlook).
• Strong math, writing, and technical skills.
• Strong attention to detail.
• Full understanding of scientific units of measure and methods for converting units of measure.
• Working knowledge of proper rounding techniques for numerical data.
• Ability to evaluate graphical data plots to verify process parameters and processing end points.
• Ability to keep accurate records and able to perform mathematical calculation.
• Ability to quickly make decisions and understand the impact on processes and product quality.
• Strong understanding of how critical process parameters impact finished product quality attributes.
• Understanding of chemistry and microbiology concepts relevant to the manufacture of sterile, specialty injectable products in an aseptic clean room environment.
• Strong working knowledge of advanced pharmaceutical manufacturing.
• Excellent verbal and written communication skills.
• Excellent attention to detail for documentation in production documents and to compare produced goods against specified requirements.
• Ability to legibly complete required documentation.
• Strong analytical and problem solving skills.
• Ability to support management decisions and communicate change positively.
• Ability to demonstrate ownership for their responsibilities and their team's performance.
• Ability to complete donning of personal protective equipment and showering during the de-gowning process.
• Ability to lead by example and have a proven record of excellence in attendance, dependability and safety.

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

• Interacts with peers and members of other departments in team settings in a professional manner.
• Provides consistent coaching, guidance, development and mentorship to operators and technicians.
• Maintains open and constructive dialogue with other leaders.
• Ability to communicate technical details of manufacturing process to members of management.

Education & Experience

• High school diploma or equivalent required.
• Bachelor's degree in scientific discipline or related field or equivalent experience preferred.
• Four or more years of experience in a manufacturing role within the pharmaceutical industry preferred, other manufacturing experience considered.
• Experience in advanced or complex manufacturing processes preferred.
• Previous supervisory experience strongly preferred

Working Conditions

• Shift work in a manufacturing.
• May require overtime.

Compensation and Benefits

• Annual pay range $83,000 - $88,000 depending on experience
• Shift differential 10%
• Bonus Eligible
• Benefits information: 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.