Production Manager
10 hours ago
Huntsville
Job Description 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. Quality Events • Promote and enforce Good Documentation Practices (GDP) and data integrity expectations. Process Improvement • Identify opportunities to improve efficiency, reduce waste, improve throughput, and enhance overall operational performance. Compliance • Ensure all operations are executed in accordance with approved SOPs, batch records, cGMPs, and applicable regulatory requirements (FDA, USDA, and other governing bodies). Safety • Champion a strong safety culture by enforcing all safety policies, procedures, and safe work practices. 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. 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. & 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 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