Manufacturing Manager (Formulation Experience Required) - ADEPT HRM Solutions

We are looking for an exceptional Manufacturing Manager. This job position presents a distinctive and thrilling opportunity for the ideal candidate.

The company is a small leading company specializing in the design and manufacturing of high-quality medical supplies and equipment. With a strong focus on innovation and precision, they built a reputation for delivering reliable solutions to the healthcare industry. The company is known for its commitment to customer satisfaction, offering tailored products and services that meet the specific needs of its clients

Job Overview

The Manufacturing Manager will plan, schedule, and manage the manufacturing, kitting, and Repackaging of our products. Ensures all manufactured and repackaged products are produced efficiently, on time, and in compliance with quality standards.

Key Responsibilities:

• Lead day-to-day operation of the formulation, manufacturing, and packaging processes, ensuring proper safety measures are used throughout all processes.

• Manage the demand planning, production planning, and scheduling of kits, repackaging, and lab formulated products.

• Monitor and direct manufacturing functions, including formulation, filling, capping, labeling, kit assembly, and all repackaging processes.

• Implement and uphold strict quality control standards to ensure all products meet regulatory and internal quality requirements.

• Ensure compliance with industry regulations, including Good Manufacturing Practices (GMP), Good Lab Practices (GLP), safety standards, and environmental regulations.

• Revises, writes, and develops SOP's, techniques, and capabilities.

• Authors appropriate sections of regulatory documents.

• Completes training, teaching, and managing of all formulation, repackaging, and kitting team members.

• Serves as an internal expert, responsible for ensuring regulatory compliance, and compliance with state and federal laws and regulations regarding manufacturing practices.

• Assists with internal and external audits and inspections.

• Responsible for compliance assurance of formulation, repackaging, kitting, and manufacturing team members.

• Leads continuous improvement projects throughout manufacturing, using ISO 22716, GLP, GMP, Lean, and Six Sigma methodologies.

• Manages and ensures batch record compliance.

• Monitors manufacturing locations in the ERP system and works to reduce inventory discrepancies.

• Conducts quarterly conversations and annual performance evaluations that are timely and constructive.

• Ability to identify and resolve challenges within production processes.

• All other duties as assigned.

Qualifications and Experience

• Bachelor's degree in chemistry, chemistry engineering, pharmacy or other relevant hands-on formulation development.

• 5+ years' leadership experience in formulation, medical devices, or healthcare manufacturing.

• Experience leading and/ supporting internal and external audits.

• Proven background working to 21 CFR 820 and ISO 22716 and/ or 13485 guidelines.

• Experience in leading compliance with regulatory requirements for medical device or healthcare manufacturing and distribution.

• Ability to lead, motivate, and manage production teams, set clear objectives, and foster a collaborative environment.

• Knowledge of cosmetic formulations, ingredients, and manufacturing processes.

• Ability to ensure products meet quality standards, regulatory requirements, and are free from defects. Familiarity with GMP is required.

• Familiarity with industry regulations such as FDA guidelines, and other global standards for cosmetic manufacturing and safety.

• Strong organizational skills to manage production schedules, product launches, resource allocation, and cost management while adhering to timelines.

• Proficiency in using ERP systems as well as understanding the technical aspects of basic lab equipment.

• Ability to perform root cause analysis and corrective and preventive actions.

• Strong communication skills and ability to work cross-functionally with various departments.

• Ability to prioritize tasks, manage time efficiently, and handle multiple responsibilities simultaneously.

Benefits and Compensation:

· Competitive base salary of $85k-95k

· Company subsidized medical, dental, vision and retirement benefits

· Dynamic and collaborative work environment

· Opportunity to play a significant role in driving the success of our clients and growth of our business.

· Generous paid time off benefit

If you believe you have the qualifications, experience and expertise to perform this role at an above-average or higher level, we encourage you to apply!