Lead, Compounding

About the role

The Lead Compounder oversees daily compounding operations within the assigned department to ensure efficient and accurate batch production. This role is responsible for maintaining quality and compliance standards, training and mentoring team members, and ensuring equipment and documentation align with cGMP standards. The Lead Compounder plays a critical role in supporting production timelines and providing technical guidance on batch formulation and equipment operation.

Responsibilities

• Lead and coordinate compounding activities, ensuring adherence to batch records, formulas, and production schedules.
• Conduct Changeovers (C/O) between products, including equipment setup, sanitation, and validation.
• Accurately batch and sample scheduled product runs, acting as either main point of completion or reviewer.
• Provide hands-on training and guidance to compounders on safe, accurate, and efficient compounding practices, as well as GMP and safety standards.
• Maintain, review, and approve production documentation, including logbooks, batch records, and other required paperwork to ensure compliance and accuracy.
• Operate a forklift to transport materials, supplies, and finished products as needed.
• Assist in troubleshooting equipment and process issues, collaborating cross-functional teams to resolve challenges promptly.
• Participate in team meetings to communicate updates, discuss process improvements, and ensure alignment with production targets and safety standards.
• Assist in developing and implementing process improvements to enhance efficiency and product quality.
• Act as the primary point of contact for trial batches, production updates on batches, validations, flushes, or other additional compounding tasks.
• Ensure equipment is maintained, sanitized, and ready for use in compliance with cGMP.
• Lead by example in maintaining high standards of accuracy, efficiency, and attention to detail.
• Ability to set shift priorities, communicate, and collaborate effectively to meet timelines.
• Some duties may vary slightly by location.

Requirements

• High School Diploma (Preferred)
• 4-6 years in a chemical or manufacturing compounding role (Required)
• 4-6 years prior experience in a lead or mentoring capacity (Preferred)

Skills

• Advanced knowledge of batch records, equipment operation, and compounding procedures (Medium proficiency)
• Communication skills with the ability to effectively train and mentor team members (High proficiency)
• Proficient in GMP practices, including documentation and process adherence (High proficiency)
• Ability to accurately complete and review production documentation (High proficiency)
• Proficiency in MS Word, Excel, JDE, PV, DSI, and retrieval of SOPs (High proficiency)
• Mathematical skills for accurate measurement and batch preparation (High proficiency)
• Ability to become certified or licensed to operate forklifts (High proficiency)
• Experience with Changeover procedures and equipment sanitation requirements (Medium proficiency)
• Capable of coordinating with customers and cross-functional teams for trial and special batches (Medium proficiency)
• Troubleshooting skills for compounding and equipment-related issues (Low proficiency)

Benefits

We provide eligible full-time employees with a comprehensive benefits package that includes medical/Rx, dental, and vision insurance options, along with applicable flexible and health spending accounts (FSA/HSA). In addition, we also offer options for life and AD&D insurance (basic and supplemental) along with short- and long-term disability insurance (basic and supplemental). Other supplemental benefit options include accident, hospital indemnity, and critical illness insurance along with identity theft protection. Employees can take advantage of a 401(K)-retirement savings plan with company match, paid vacation, paid sick time, paid holidays, and education reimbursement. This comprehensive benefits package is designed to offer valuable support for you and your family’s health, financial security, and work-life balance. Specific benefits and eligibility may vary by location.