Director of Compounding & Quality Manufacturing

Goodkind Co; Round Rock (TX); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Competitive salary

3 weeks PTO

11 holidays

Medical, Vision, and Dental paid by co

401k with company match

Paid parental leave

Job summary

Goodkind Co. in Austin area seeks a Director of Compounding to lead all batch manufacturing activities, drive continuous improvement, and ensure readiness for FDA or client audits.

You will oversee raw material staging, batching, in-process control, and release of bulk to filling while maintaining strict quality and schedule targets. The role requires hands-on experience with hot pour and emulsions, deep cGMP knowledge, and a track record of leading multi-SKU contract manufacturing with strong

Qualifications

• Bachelor's Degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or related field, or equivalent experience.
• Minimum 10+ years experience in cosmetic, personal care, OTC, or pharmaceutical batch manufacturing.
• 5+ years of management experience leading a compounding or manufacturing function with multiple direct reports.
• Hands-on experience with hot pour / anhydrous stick products and emulsions at commercial scale, including the process sensitivities of waxes, fatty alcohols, and glycol-based systems.
• Working knowledge of cGMP (21 CFR 210/211) and ISO 22716; experience hosting or supporting FDA and customer audits.
• Proven record of improving yield, right-first-time, and schedule attainment in a contract manufacturing or multi-SKU environment.
• Experience with scale-up and tech transfer from R&D to production.
• Ability to read and interpret formulas, batch records, COAs, and specifications, and to troubleshoot a batch on the floor.
• Previous experience in contract manufacturing serving multiple brand customers a plus.
• OTC drug manufacturing experience a plus
• Experience implementing or operating an electronic batch record or eQMS system a plus
• Lean or Six Sigma training with examples of applied improvement work a plus
• Experience in fast-paced, high-volume organization, which mandates quick decision making and effective communication
• Continuous improvement attitude; ability to suggest and implement best practices.
• Highly fluent in computer operation with experience with various software applications (ERP, Google Suite, Microsoft Office, Asana, Slack, etc)
• Excellent written, verbal, and interpersonal communication skills; ability to communicate and collaborate across all levels of the organization
• Demonstrated ability to positively influence others and to deal tactfully and confidently with difficult situations
• Highly consistent and organized, with the ability to maintain accurate and timely records
• Ability to work onsite at the Austin-area facility, including daily time on the production floor around hot equipment and chemical handling

Responsibilities

• Direct and optimize all compounding operations, including raw material staging, weigh-up, batching, in-process testing, and bulk transfer to filling, to meet schedule, yield, quality, and cost targets.
• Run hot pour, emulsion, and cold-process batching across kettles, mixers, and transfer systems; set and enforce process parameters such as temperature profiles, mixing speed and time, order of addition, and cooling and hold conditions.
• Deliver batches that meet specification on the first attempt; own batch adjustment, rework, and scrap rates and drive them down.
• Ensure every batch record is complete, accurate, and reviewed in real time, not after the fact.
• Lead deviation investigations, root cause analysis, and CAPA for compounding events in partnership with Quality, and close actions on time.
• Keep the compounding area inspection-ready every day under cGMP (21 CFR 210/211), ISO 22716, and customer audit standards; represent compounding in FDA, client, and third-party audits and respond to findings with durable corrective actions.
• Own compounding SOPs, work instructions, cleaning and sanitization procedures, and equipment logs; keep them current, trained, and followed.
• Partner with R&D and Process Engineering on scale-up and tech transfer of new formulas; confirm process parameters before the first commercial batch.
• Own equipment readiness and utilization for compounding assets; partner with Maintenance on preventive maintenance, calibration, and capital requests.
• Build and maintain a documented training and qualification program for every compounding role so that no one runs a process they are not qualified on.
• Ensure compounding operations comply with safety standards, including hot surfaces, chemical handling, PPE, and lockout/tagout, and maintain a safe, organized, and efficient working environment
• Define, track, and report compounding KPIs (schedule attainment, yield, right-first-time, deviations, safety) and use them to prioritize improvement work
• Analyze volume, throughput, and capacity to develop labor, equipment, and shift plans that support business growth
• Manage department budget, associated costs, and resources
• Participate as a member of the operations team in making cross-functional operational decisions
• Collaborate with Planning, Filling and Packaging, Quality, R&D, Supply Chain, and Project Management to keep customer commitments
• Select, evaluate, develop, and manage compounding supervisors, leads, and technicians across shifts to ensure the efficient operation of the function
• Identify and resolve complex technical, operational, and organizational problems

Skills

Batch manufacturing

Leadership

cGMP knowledge

Process optimization

Audits

Scale-up

Lean Six Sigma

ERP

Asana

Slack

Education

Bachelor's degree in Chemical Engineering or related

Tools

ERP

Asana

Slack

Google Suite

Job description

Goodkind Co. in Austin area seeks a Director of Compounding to lead all batch manufacturing activities, drive continuous improvement, and ensure readiness for FDA or client audits.

You will oversee raw material staging, batching, in-process control, and release of bulk to filling while maintaining strict quality and schedule targets. The role requires hands-on experience with hot pour and emulsions, deep cGMP knowledge, and a track record of leading multi-SKU contract manufacturing with strong