Sr. Supervisor Production - Specialty Injectables

Tolmar Careers•Windsor, CO

18h•$100,000 - $110,000•Onsite

About The Position

The Senior Supervisor Production – Specialty Injectables serves as a strategic leader, providing oversight and direction to the Specialty Injectables team to ensure the consistent delivery of high-quality products for patients. This position is responsible for orchestrating and optimizing shift production operations, including workforce management, resource allocation, and comprehensive planning within the manufacturing environment. Specialty Injectables encompasses advanced sterile filling/bulking as well as sophisticated non-sterile bulking (Polymer) processes, requiring a focus on operational excellence and continuous improvement.

Requirements

Mastered knowledge of current Good Manufacturing Procedures (cGMP) as they relate to sterile injectable manufacturing.
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 interact with peers and members of other departments in team settings in a professional manner.
Proven ability to provide consistent coaching, guidance, development and mentorship.
Ability to maintain open and constructive dialogue with other leaders.
Ability to communicate technical details of manufacturing process to members of management.
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.
Bachelor’s degree in a science or engineering discipline, plus a minimum of 4 years of GMP manufacturing experience that includes leadership and training responsibilities; OR a technical diploma or Associate’s degree, plus at least 6 years of GMP manufacturing experience with leadership and training responsibilities; OR a high school diploma or GED, plus a minimum of 8 years of GMP manufacturing experience, including leadership and training responsibilities.
Demonstrated competence in aseptic operations, troubleshooting, and cross-functional collaboration.
Six Sigma Green Belt certification is required, or the candidate must obtain it within one year of hire.

Responsibilities

Actively supervises and manages the performance of non-exempt manufacturing employees in the Specialty Injectables manufacturing group.
Independently leads Continuous Improvement (CI) projects that deliver measurable gains (i.e. increasing Overall Equipment Effectiveness (OEE) by 5% or reducing documentation errors by 20%).
Standardizes work processes by implementing visual controls and comprehensive checklists, and actively verifies that these standards are consistently adopted on the production floor.
Mentors and develops operators and future leaders through hands-on coaching, structured training sessions, and ongoing support, while facilitating department-wide training initiatives to ensure overall readiness.
Guides Team Leads and Operators by creating tailored development plans with specific, measurable milestones to track progress and foster professional growth.
Sets tiered goals, including daily and weekly Key Performance Indicators (KPIs), and maintains a regular cadence of accountability using performance scorecards to drive results.
Intervenes proactively on performance gaps by designing individualized coaching plans and thoroughly documenting improvement actions to support sustained success.
Leads the resolution of complex technical and personnel issues by applying advanced troubleshooting techniques and collaborating with cross-functional teams.
Independently diagnoses root causes of equipment and process disruptions, documents findings, and recommends actionable solutions to prevent recurrence.
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.
Conducts interviews and participates in making hiring decisions for non-exempt 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 manufacturing processes.
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 Operators who conduct or coordinate the in-process training, including line orientation and risk review, for all new team members.
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/Tolway) on a timely basis.
Performs investigations and CAPA implementations for non-conforming events.
Pre-approves expiration dates on batch records prior to manufacturing.
Conducts employee performance evaluations.
Reviews and approves direct report timesheets.
Performs other related duties as assigned.