Position Overview:

We are seeking a Senior Manager, External Manufacturing responsible for establishing and managing production and relations at External Manufacturing CDMOs along with support of key Supply Chain initiatives. This is a key role that requires excellent organizational and collaboration skills experience dealing with internal and external partners and technical skills required to manage a cross-functional team overseeing the sourcing, selection and production / testing of gene editing components. Areas of focus will include development of fit for purpose processes for supplier management and their governance establishing and driving cadence for supplier dashboards / budgeting / risk identification and management, organizing ways of working both internally and cross-functionally, organizing and deploying tools to manage information, aligning with internal stakeholders (Process Development, Analytics, QA, CMC, Asset Teams, etc.), support the design and rollout of supply planning and supplier/raw materials management, organize product and sample shipping logistics, invoicing and POs, etc. Ideally, the incumbent will have the necessary skills / experience and ultimately the desire to advance into either an External Manufacturing or Supply Chain leadership role. 

Responsibilities:

• Provide oversight of CDMO operations including supply planning and production plans, management of manufacturing vendor change notifications; lead or assist with manufacturing deviations, customer complaints, and product failure investigations.
• Organizes proposal responses, establish data repository and supports the development of outsourcing models, vendor evaluation, and CMO selection in close collaboration with key internal stakeholders.
• Project Management of CDMO’s and critical suppliers; including driving cadences for budget planning & tracking, contracts, and manufacturing tactical execution.
• Establish and foster strong collaborative relationships with external manufacturing counterparts & partners and service providers.
• Establish and maintain detailed project plans, drive risk management program cadence.
• Support supply planning by driving cadence, collecting and organizing data into meaningful output
• Resource planning, generating metrics/ KPIs, and presentation of materials for internal stakeholder review.
• Travel for in-person interactions with multiple contract manufacturing entities to ensure production is on plan and to foster good relations.
• Perform other related duties and ad hoc projects as required by position and in support of the Head Supply Chain and External Manufacturing.

Qualifications:

• Bachelor of Science and 7+ years’ experience in project management / biologics manufacturing required; C> preferred.
• Understanding of external manufacturing operations and quality systems required.
• Experience or understanding of clinical supply chain planning, raw material supply, chain of identity, etc.
• Knowledge of cGMP requirements is a must.
• Leadership skills with a PM track record of delivering on established goals & objectives
• Strong communication skills (written and verbal), including experience presenting in front of multidisciplinary stakeholders and senior management.