What are the responsibilities and job description for the Production Manager position at TriRx Shawnee LLC?

Job Summary - a concise overview of the job
Oversees department specific operations to ensure quality and safety standards are met and the operations are efficient and organized. Maintains facilities in highest level of compliance and cleanliness and ensures operating procedures are executed in accordance with all regulations. Provides direct supervision and coaching to front line employees and promotes open and collaborative work environment. Provides daily expectations to employees and ensures all necessary resources are available for employees to perform at highest safety and quality levels. Perform other duties as assigned
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
The Production Manager has authority over day-to-day Manufacturing and Packaging operations, including directing personnel, assigning work, setting daily priorities, and stopping operations when safety, quality, or compliance risks are identified. This role is empowered to make operational decisions within approved procedures and to escalate and collaborate with Quality, EHS, and site leadership as needed to ensure regulatory compliance and business objectives are met.

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
Accountability	Responsibilities	% of Time
Floor Operations	Lead day-to-day Manufacturing and Packaging operations to ensure safe, efficient, and organized execution of production activities. Establish daily production expectations and priorities aligned with schedule commitments, quality requirements, and safety standards. Ensure all required resources (personnel, materials, equipment, documentation) are available to enable teams to perform at the highest safety and quality levels.	60%
Quality Events	Promote and enforce Good Documentation Practices (GDP) and data integrity expectations. Support audits, inspections, investigations, deviations, CAPAs, and continuous improvement initiatives related to Manufacturing and Packaging.	10%
Process Improvement	Identify opportunities to improve efficiency, reduce waste, improve throughput, and enhance overall operational performance. Collaborate cross-functionally with Quality, Maintenance, Engineering, Supply Chain, and EHS to drive operational excellence.	30%
Compliance	Ensure all operations are executed in accordance with approved SOPs, batch records, cGMPs, and applicable regulatory requirements (FDA, USDA, and other governing bodies). Maintain the facility, equipment, and production areas in the highest level of compliance, cleanliness, and inspection readiness at all times.	continuous
Safety	Champion a strong safety culture by enforcing all safety policies, procedures, and safe work practices. Ensure teams are properly trained and compliant with safety requirements, and that hazards are promptly identified and addressed.	continuous
Total	100%

Qualifications
Education & Experience	Minimal acceptable level of education, work experience and certifications required for the job
Bachelor’s degree in Manufacturing, Engineering, Life Sciences, or a related field, or equivalent experience. Minimum of 5 years of progressive leadership experience in pharmaceutical, animal health, or regulated manufacturing environments. Strong working knowledge of cGMPs, safety regulations, and quality systems in a non-sterile manufacturing environment. Proven experience leading manufacturing and/or packaging teams. Experience in a contract manufacturing (CDMO) environment. Experience with liquid manufacturing and packaging operations. Lean manufacturing or continuous improvement experience.
Page Break Knowledge & Technical Expertise	Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
Strong understanding of the chemistry and formulation principles behind non-sterile liquid manufacturing, including solutions, suspensions, and emulsions used in pharmaceutical and animal health products. Working knowledge of raw material properties (active ingredients, excipients, solvents, surfactants, preservatives, and flavoring agents) and how they impact product stability, appearance, and performance. Understanding of pH control, solubility, viscosity, density, and temperature effects on liquid formulations and their impact on mixing, filling, and packaging operations Knowledge of common liquid manufacturing challenges such as foaming, precipitation, settling, air entrainment, microbial risk, and cross-contamination, with the ability to recognize and respond to process deviations. Understanding of cleaning and sanitation requirements for liquid manufacturing equipment, including CIP/SIP concepts, residue carryover risks, and cross-contamination prevention in non-sterile environments. Awareness of process controls and in-process testing used in liquid manufacturing. Ability to interpret and execute batch records, formulation instructions, and SOPs with an understanding of the underlying chemistry and process intent. Familiarity with material compatibility (product-to-equipment, product-to-container) and its role in stability, leachables, and overall product quality.
Skills & Abilities	Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
Strong leadership, coaching, and communication skills High attention to detail with a quality-first mindset Ability to manage priorities in a fast-paced production environment Strong problem-solving and decision-making capabilities Collaborative leadership style with the ability to influence across departments
Physical Requirements	Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
Occasionally required to reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl Occasionally lift and/or move up to 50 pounds Specific vision abilities required by this job include color vision Occasionally exposed to moving mechanical parts. The noise level in the work environment is usually moderate

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