Associate Director, Commercial Manufacturing & Packaging

Planet Pharma; San Diego (CA); On-site; USD 150,000 - 195,000; Full time

Job summary

Planet Pharma seeks an Associate Director, Commercial Manufacturing to lead the external manufacturing network for drug products. You will steer manufacturing planning, CMO governance, validation, tech transfer, and risk management to ensure reliable supply and compliance.

You will partner with Supply Chain, Quality, Regulatory Affairs, and Commercial teams to translate forecasts into executable plans and advise senior management on capacity, resources and external manufacturing strategy.

Qualifications

• 8+ years of progressive experience directly leading pharmaceutical manufacturing and packaging shop floor activities, including process troubleshooting and optimization.
• Experience with multiple dosage forms, including oral solid dosage forms.
• Bachelor’s degree in Process or Chemical Engineering, Life Sciences, or related discipline.

Responsibilities

• Direct and coordinate manufacturing activities at CMOs for commercial drug products to ensure uninterrupted market supply.
• Establish and maintain manufacturing schedules based on internal sales forecasts and S&OP decisions; assess capacity, inventory, and supply risks and lead the development of mitigation and contingency plans.
• Verify suitability, qualification and validation of processes at Contract Manufacturing Organizations (CMO) for drug product.
• Provide manufacturing support, troubleshooting, on internal and external project teams.
• Maintains up-to-date knowledge of US and EU GMPs and other regulatory guidance applicable to pharmaceutical drug product manufacturing and packaging.
• Represent commercial manufacturing for technical due diligence, CMO selection, qualification, contracting support, and manufacturing-network strategy.
• Author/edit technical reports on a variety of manufacturing-related subjects as needed.
• Assist management during regulatory inspections and internal, and external audits.
• Assist with the development of CMC sections of regulatory submissions.
• Additional duties assigned as needed.

Education

Bachelor’s degree in Process or Chemical Engineering, Life Sciences, or related discipline

Job description

Planet Pharma seeks an Associate Director, Commercial Manufacturing to lead the external manufacturing network for drug products. You will steer manufacturing planning, CMO governance, validation, tech transfer, and risk management to ensure reliable supply and compliance.

You will partner with Supply Chain, Quality, Regulatory Affairs, and Commercial teams to translate forecasts into executable plans and advise senior management on capacity, resources and external manufacturing strategy.