Senior Manager, External Manufacturing

SERVIER MONDE • Boston, KY

3d • $163,000 - $186,000

About The Position

The Senior Manager, External Manufacturing supports manufacturing activities spanning 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 Servier’s External Manufacturing organization and serves as a tactical and strategic partnering resource. It requires detailed knowledge of commercial pharmaceutical and biologics manufacturing and awareness of developments in the global market.

The role provides oversight to Virtual Plant Teams (VPTs) to support strong Contract Manufacturing Organization (CMO) performance and meet supply requirements. It coordinates key internal and external relationships and leads cross-functional, cross-continental matrix teams across areas such as Manufacturing Sciences and Analytical Technologies (MSAT), Supply Chain, and Quality, using standard work and processes, lean practices, and continuous improvement.

The position manages CMO relationships, including contract and operational matters, performance reviews, problem resolution, quality and compliance systems, financial coordination, operational excellence, and business continuity planning. It interfaces regularly with Supply Chain to monitor supply needs and milestones, and coordinates product activities, risks, contingencies, and mitigation plans. The role is within Servier’s Global External Manufacturing organization, headquartered in Boston, MA, and requires approximately 25% domestic and international travel.

Requirements

• Minimum 6 years of experience in the pharmaceutical industry.
• Effective communication skills and ability to influence people at every level.
• Strong experience working in multifunctional teams and using risk management processes.
• Demonstrable experience protecting and maintaining confidentiality, intellectual property, and know-how.
• Knowledge of FDA, EU, and global-region cGMP compliance.
• Experience leading cross-functional, cross-continental teams.
• Excellent interpersonal skills for working in a high-performance culture.
• Ability to tolerate ambiguity and uncertainty and champion change when appropriate.
• Ability to collaborate with other business areas and manage and resolve conflict.
• Demonstrated leadership capability.
• Demonstrated project and program management capability.
• Ability to train, mentor, and lead new team members; experienced in people management and mentoring.
• Strong technical and financial background.
• Experience with statements of work, purchase orders, and invoicing.
• BS/MS in a scientific or engineering field, or relevant experience exceeding 10 years.

Nice To Haves

• Proven and demonstrable experience managing and negotiating contracts.
• Experience with process scale-up and optimization, technology transfer, and analytical techniques.
• Advanced degree.
• PMP certification.

Responsibilities

• Manage relationships with CMOs, including contract negotiations, contractual obligations, and routine relationship matters.
• Coordinate communications with internal support groups regarding commercial and clinical manufacturing needs.
• Support CMO problem resolution and continuous improvement programs, assess corrective measures, and evaluate outcomes.
• Promote a right-first-time culture through proactive attention to preventing undesirable events.
• Coordinate routine Operational Review Meetings and Joint Steering Committee meetings with CMOs.
• Help identify CMO key performance indicators, prepare performance metrics, and develop topics for routine business review meetings.
• Ensure CMO quality, safety, and environmental systems are effective and support continuous improvement initiatives where needed.
• Partner with CMOs to monitor and support supplier concerns when appropriate.
• Coordinate the financial relationship with CMOs, including initiating purchase orders and ensuring vendor invoices are accurate and paid on time.
• Lead and support operational excellence initiatives internally and with CMOs.
• Work with CMOs to create or continually improve business continuity plans.
• Interface regularly with Supply Chain to stay informed about critical market needs and priorities, and communicate with support groups to address priorities and patient needs.
• Maintain tracking tools for drug product lot release, drug product lot shipment, and component artwork delivery; monitor timing to support continuity of supply.
• Identify and drive opportunities to eliminate waste and improve supply chain efficiencies.
• Communicate and coordinate critical business-unit activities to ensure objectives are met.
• Identify risks and deficiencies, address bottlenecks, and coordinate risk mitigation with project teams and Servier management.
• Address business-unit personnel and supply risks and contingencies internally and externally.
• Monitor risks and issues, create mitigation plans, and drive accountability.
• Perform other duties as directed by the Manager or Functional Management.
• Travel as required to meet business needs.
• Keep current with industry regulatory and compliance trends and publications, and comply with applicable legislation and Servier policies.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Flexible time off, including unlimited sick time and flex time with no accrued time off
• 401(k)
• Life insurance
• Disability insurance
• Recognition programs
• Short-Term and Long-Term incentive programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior