Associate Director External Manufacturing Operations

Job description

The Associate Director External Manufacturing Operations is responsible for leading oversight of the CMO’s daily operations ensuring proper management of drug substance manufacturing for Sanofi products. 

Who You Are

You are a strong communicator with demonstrated ability to engage, motivate and lead teams both internally and externally to deliver continuous manufacturing with external partners.

You have an innate ability to connect the dots and influence decisions across the product value stream at all levels.

You emphasize continuous improvement and utilize a risk-based decision-making process without compromising on compliance, but delivering the best value for Sanofi.

Who We Are

Specialty Care External Supply (SCES) is a Global team that manages relationships with external Contract Manufacturing Organizations (CMOs) as suppliers of drug substance, drug products and finished goods for Sanofi Biologics. The team is focused on two areas of operation, North America and Europe. We oversee the external network as if it were a multi-product site, effectively managed and fully integrated into Sanofi’s business model.

Where We Are

Our North American team is located in Waltham, Massachusetts and provides support for all manufacturing activities occurring in North America. The fully integrated team includes Supply Chain, Quality and Operations.

Waltham is a small city located approximately 17 miles west of Boston with convenient highway access and public transport.

Job Highlights

The position is accountable for managing drug substance manufacturing operations at the assigned Contract Manufacturing Organization (CMO), taking responsibility for delivery against the contract. The candidate is the primary Sanofi interface for all communications with site manufacturing activities (virtual plant manager) and is expected to manage operations and communicate effectively to create value in meeting Sanofi’s business objectives.

           

The position supports all project management initiatives at the supplier site including tracking KPIs, manufacturing technical transfers, new product introductions, compliance initiatives and continuous improvement projects. The candidate will routinely manage and contribute to projects requiring close collaboration with Technical Development, Regulatory Affairs, Legal, Quality, Finance, Logistics, Planning and Business Operations. The position may also require Operations support of 3rd party Alliance Partnerships across Sanofi’s Biologics portfolio.

Core Responsibilities

·  Key member of CMO joint project teams representing External Manufacturing Operations,
·  Key member of the iCMC and Industrial Product Teams representing External Manufacturing Operations,
·  Ensure proper governance model is implemented to enable efficient manufacture of product,
·  Partners with Production Managers and Support functions both within Sanofi and CMO to effectively create and execute schedules,
·  Escalate key risks and issues to senior management and cross-functional support teams.,
·  Partners with Key Account Management to ensure production capacity is in alignment to requirements and contract obligations,
·  Lead internal core team meetings for all areas supporting CMO (QA, QC, Supply, Logistics, Operations, MSAT, etc.) ensuring cross functional representation and participation,  
·  Lead Periodic Business Review meetings with CMOs including management of internal prep meetings.
·  Provide Operations support for 3rd party product Alliance Partnerships, as needed to support Sanofi business objectives.

Production Oversight

·  Ensures production at CMO is meeting stated goals.  Raise awareness of issues to senior management and cross functional groups. Drive and lead teams to ensure timely resolution of issues and control of production is maintained,
·  Facilitates the scheduling of Material Deliveries, QC testing, Production Operations and projects to minimize the impact to the manufacturing schedule,
·  Monitors CMO performance against production goals; identifying and resolving gaps,
·  Tracks and communicates the status of work-in-progress, material availability, pending material expiration dates and schedule changes,
·  Monitors and verifies inventory balances,
·  Monitors production closure to ensure timely ERP transactions,
·  Owns and improves the Schedule Adherence systems and partners with appropriate departments to ensure effective performance measures and continuous improvements are implemented, 
·  Develops. monitors, and reports Key Performance Indicators in conjunction with CMO,
·  Reviews daily schedules and document process sequences, cycle times and conflicts with CMO personnel,
·  Utilizes consistent ways of working and communication tools to manage both internal and external CMO working teams,
·  Act as CMO Subject Matter Expert (SME) ensuring process changes are vetted within Sanofi. Facilitate implementation of projects in conjunction with CMO organization,
·  Manage budget and financial accruals process for CMO,
·  Support Quality Management Systems, as needed to provide SME support for deviations, CAPAs and change controls.

BASIC QUALIFICATIONS:

·  BSc in a science or technical field,
·  At least 7 years in the pharmaceutical / biologics industry with at least 3 years prior experience in biologics drug substance manufacturing,
·  At least 3 years’ experience working with or for Contract Manufacturing Organizations (CMOs),
·  Strong communicator with demonstrated ability to engage, motivate and lead teams.

PREFERRED QUALIFICATIONS:

·  Project management within highly matrixed teams,
·  Experience with public speaking and presenting complex information to a wide audience,
·  Experience in contract management,
·  Ability to problem solve and drive for results,
·  Commitment to continuous improvement including experience implementing OpEx principles such as LEAN or Six Sigma,
·  High-level proficiency with Microsoft PowerPoint and Excel,
·  Ability to travel, as needed to support onsite manufacturing oversight (no more than 20%).

Terms of Employment

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SG

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.