Senior Manager, External Manufacturing

Role Summary

The Senior Manager, External Manufacturing supports various manufacturing activities such as drug substance manufacturing, API procurement and manufacturing, finished dose, packaging, quality control testing, quality assurance and supply chain. The role initiates, develops, and manages supplier relationships in support of the External Manufacturing (ExM) organization in order to achieve Servier's business objectives.

The role requires detailed knowledge of commercial pharmaceutical and biologics manufacturing, keeping up to date with changes and developments within the global market. Strong leadership and communication skills are required as the role involves leadership of cross-functional, cross-continental teams comprised of both internal Servier and external Contract Manufacturing Organization (CMO) members. Proficiency with lean practices and standard work and processes is a requirement.

The primary focus of the role is to provide oversight to the Virtual Plant Teams (VPTs) focused on ensuring high CMO performance by meeting all supply requirements. This is accomplished by coordinating and addressing the needs of key relationships and management of cross functional matrix teams within Manufacturing Sciences and Analytical Technologies (MSAT), Supply Chain, Quality, and other functions.

Specific Responsibilities

CMO Relationship Management

• Interface with each CMO addressing contract negotiation, contractual obligations and all other routine issues/concerns involving the relationship
• Coordinate and assist in communications with key support groups addressing commercial and clinical manufacturing needs
• Assist CMO with problem resolution and Continuous Improvement (CI) programs, assessing corrective measures and the success of their outcome
• Develop a right first time culture with proactive attention to avoid undesirable events where possible
• Coordinate routine Operational Review Meetings (ORM)/Joint Steering Committee (JSC) meetings with each CMO at defined frequencies
• Assist in the identification of CMO key performance indicators, the preparation of performance metrics and all other agenda topics to be presented and discussed at routine BRMs
• Ensure CMO's quality, safety and environmental systems are effective and where needed engaged in continuous improvement initiatives
• Where appropriate partner with CMO to monitor and support supplier concerns
• Coordinate and address the financial relationship between both parties by initiating purchase orders and ensuring that vendor invoices are accurate and paid on time
• Lead and support operational excellence initiatives both internally and with CMOs
• Work with CMOs to create or continuously improve a Business Continuity Plan

Supply Chain Interface – Continuity of Supply

• Interface with Supply Chain on a regular basis keeping abreast of critical market needs and priorities
• Communicate with support groups as needed to address priorities and patient needs
• Maintain tracking tools used for drug product lot release, drug product lot shipment and component artwork delivery, monitor to ensure continuity of supply and planned timing of events
• Assist with and drive opportunities to eliminate waste and improve efficiencies from the overall supply chain process

Product Coordination

• Effectively communicate and coordinate all critical activities involving the business unit to ensure objectives are met
• Highlight risks / deficiencies and proactively address bottlenecks through detailed communication and risk mitigation by interfacing with project Teams and Servier management
• Address business unit personnel and supply risks/contingencies both internally and externally
• Actively monitor all risks and issues, create mitigation plans, drive accountability

Other Duties

• Travel as required to meet the needs of the business
• Keep current with industry regulatory, compliance trends and publications
• Comply with appropriate legislation and Servier policies

Education & Skills

• Minimum 6 years in the pharmaceutical industry
• Proven and demonstrable experience in managing and negotiating contracts, preferred
• Effective communication with ability to influence others at every level
• Strong experience in a multi-functional team role utilizing risk management processes
• Demonstrable background/experience in protecting/maintaining Confidentiality, Intellectual Property and Know-How
• Experience with process scale up and optimization, tech transfer and analytical techniques preferred
• Well versed in FDA, EU and global regions cGMP compliance
• Experience leading cross-functional, cross-continental Teams
• Excellent interpersonal skills needed to work in a high-performance culture
• Demonstrates tolerance for ambiguity, uncertainty and champions change when appropriate
• Collaborates well with other areas of the business
• Ability to manage and resolve conflict
• Demonstrated leadership capability
• Demonstrated project and program management capability
• Ability to train/mentor/lead new team members
• Experienced people manager and mentor
• Strong technical and financial background
• Experience with statements of work (SOW), purchase orders, and invoicing
• Education Required: BS/MS in Scientific /Engineering field, or relevant experience >10 years
• Advanced Degree desirable
• PMP Certification desirable

Other Relevant Information

Approximately 25% domestic and international travel is required to meet the needs of the business. Position is located within the Servier Global External Manufacturing organization with headquarters located in Boston, MA.