Associate Director, Commercial Drug Product Manufacturing and Packaging

Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women’s health, rare disease, and cell & gene therapies. The company’s diverse portfolio includes several marketed products and a robust pipeline of early- to late-stage assets. Building on Sumitomo Pharma’s 125-year legacy of innovation, SMPA leverages proprietary in-house technology platforms and advanced analytics capabilities to accelerate discovery, development, and help bring novel therapies to patients sooner. SMPA is a Sumitomo Pharma company. [For more information, visit Sumitomo-pharma.com]

Job Overview

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director, Commercial Drug product Manufacturing and Packaging

The Associate Director, Commercial Drug product Manufacturing and Packaging is responsible for overseeing crucial manufacturing production and ensures uninterrupted supply of SMPA’s commercial Oral Solid Dosage (OSD) portfolio through successful execution of production campaigns within our global network of external contract development & manufacturing organizations (CDMOs).

This role will serve as a leader and work with external manufacturing sites to ensure quality and compliance is met, provide technical oversight; collaborates with internal stakeholders and alliance partners to bring commercial product to desired markets; leads technology transfer and ensures commercial preparedness for manufacturing at CMOs.  

The individual must have the ability to work independently, be an effective and engaged technical and strategic leader in a fast-paced environment. This role requires excellent technical expertise, strong interpersonal skills and outstanding communication skills to enable the manufacture and delivery of important medicines to patients.

Essential Duties and Responsibilities 

• Oversee and coordinate the overall evaluation and selection of external contract development & manufacturing organizations (CDMOs) for commercial needs. 
• Serves as a point of contact for Contract Development & Manufacturing Organizations (CDMOs), and act as technical lead. 
• Actively manages CDMOs in assigned projects to coordinate technology transfer and development efforts per project milestones, timelines, and deliverables for projects. 
• Reviews and coordinates Quality related documents pertaining to production with CDMO’s (complaints, deviations, change controls, OOS, etc.) 
• Assists in coordinating release and stability tests for drug product manufacturing and packaging. 
• Responsible for implementation and maintenance of serialization systems to ensure compliance with regulatory requirements and enhance traceability within the pharmaceutical manufacturing process
• Monitors and verifies implementation of SMPA‘s controlled documents at CDMOs partner sites. 
• Assist in review and revision of departmental SOPs in order to streamline and improve current practices. 
• Manages CDMOs on a daily basis, responsible for all interactions with CMO’s on the assigned projects. 
• Works with line manager and partner functions to develop processes/systems to effectively manage vendor selection and performance assessments. 
• Participates in solving issues of high complexity. 
• Communicates issues to line manager and project team in a timely manner. 
• Develops specific manufacturing recommendations for coordination of production schedules, environmental concerns, and safety issues. 
• Coordinates production flow from Process Development to Manufacturing. 
• Responsible for driving continuous improvement in all operation processes. 
• Assist in continuous process verification (CPV) of all products. 
• Perform other duties as assigned. 

Core Competencies, Knowledge, and Skill Requirements 

• Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment, honesty, integrity, and trust building
• Serve as an ambassador for SMPA and key partnerships
• Professional behaviors in all dealings is