Associate Director, Commercial Manufacturing & Packaging

Reference: 631320

Posted:

Location:

San Diego, California Company:
Planet Pharma Group Contact:
Applications Email: applications

Position Summary:

The Associate Director, Commercial Manufacturing is accountable for the strategy, oversight, and execution of commercial drug product manufacturing and packaging activities across external manufacturing network. This role leads manufacturing planning, CMO governance, process validation, technology transfer, operational performance, and supply-risk management to ensure a reliable, compliant, and uninterrupted supply of commercial products. The Associate Director partners with Supply Chain, Quality, Regulatory Affairs, Technical Operations, and Commercial stakeholders to translate business forecasts and product strategies into executable manufacturing plans and to provide senior management with recommendations regarding capacity, resources, risk, and external manufacturing strategy.

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 Sales & Operations Planning meeting 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/Experience Requirements:  Bachelor’s degree in Process or Chemical Engineering, Life Sciences, or related discipline required. Equivalent combination of education and applicable job experience may be considered.
8+ years of progressive experience directly leading pharmaceutical manufacturing and packaging shop floor activities including process troubleshooting and optimization activities required.

Manufacturing experience with multiple dosage forms desired, including oral solid dosage forms. Additional Skills/

Experience:

The ideal candidate will embody core values:
Courage, Community Spirit, Patient Focus and Teamwork.

Driven, intelligent, passionate about making a difference for patients with rare diseases.

Expert knowledge in process validation and technology transfer procedures.

Successful record of creating and managing complex project plans, timelines, and budgets, and development of risk mitigation strategies.

Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.

Team player and strong interpersonal and organizational skills and excellent verbal and written communication skills.  Excellent decision-making and collaboration skills with strong attention to detail.

Ability to travel 10% domestically and internationally.

All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.

Comp based one level/experience 150-195k range