Sr. Manager Manufacturing and Operations CDx

Labcorp is a global leader in diagnostic testing and drug development solutions helping healthcare providers researchers and patients make informed decisions that advance care. Join us in our mission to improve health and improve lives.

Labcorp is seeking a Senior Manager Manufacturing and Operations CDx to join our team in Morrisville NC!

Job Responsibilities:

The Senior Manager is a handson CDx Manufacturing and Operations leader and will grow a small but critical Companion Diagnostics (CDx) manufacturing function. This role will work alongside an existing team member and will be directly responsible for the development manufacturing and commercialization of IVD companion diagnostic kits from clinical trials through global launch (US EU and RoW). This position requires someone who can execute daytoday technical work while also providing vision and leadership to evolve processes infrastructure and capabilities as the CDx portfolio expands. Lead manufacturing operations and ensure facility readiness in direct support of the development manufacturing and commercialization of IVD/CDx kits used in clinical trials and commercial launch for US EU and ROW markets which includes:

• Ensure manufacturing operations comply with applicable regulations and standards including FDA IVDR ISO 13485 and global IVD requirements

• Perform and oversee assay transfer manufacturing process development validation and scaleup activities. Own daytoday manufacturing execution troubleshooting documentation and lifecycle management activities in a smallteam environment

• Manufacturing of kits and preparation of final packaging of IVD products and PM activities for shipment to clients and/or Field Service Technicians

• Coordinating and expediting the flow of materials and assemblies between departments according to production and shipping schedules or department priorities

• Partner with cross-functional teams to regulatory support submissions internal and external audits and postmarket activities

• Establish metrics and KPIs to track performance quality and delivery

• Be an active member of internal project team including participating in project-set up activities and team meetings

• Represent the CDx manufacturing function in internal governance forums

• Build scalable foundations (processes documentation tools) appropriate for a growing organization

• Training and ensuring competency of manufacturing staff

Minimum Qualifications:

• Bachelor of Science degree

• 2 or more years of experience as a supervisor or manager

• 3 or more years of experience with PeopleSoft ERP systems Microsoft Office and FedEx Computer shipping software and hardware systems

• 5 or more years of experience with IVD regulations and quality systems (FDA IVDR ISO 13485)

• 10 or more years of experience in assay development and kit commercialization

Preferred Qualifications:

• 5 or more years of experience with supply chain management production inventory management manufacturing or logistics utilizing batch records

Additional Job Standards:

• Ability to effectively manage teams in a regulated environment

• Ability to effectively perform organizational analytical planning and computer skills

• Ability to be effective in verbal and written communication skills

• Ability to lead cross-functional initiatives and influence others.

• Ability to work independently and in a team environment with a professional and positive attitude

• Ability to manage and maintain relationships with internal and external partners with professionalism and manage multiple concurrent studies each at a different stage

• Ability to manage processes with high quality and master new techniques in an accelerated manner

• Ability to work effectively and efficiently under pressure to organize work and meet scheduled deadlines

• Ability to sit stand and walk for extended periods

• Ability to pull push or lift of heavy objects up to 75lbs.

Pay Range: $140k - $160k annually (USD)

All job offers will bebased on a candidates skills and prior relevant experience applicabledegrees/certificationsas well as internal equity and market data. The position is also eligible for an annual bonus under the Labcorp Bonus are payable based on corporate and/or business segment performance and are subject to individual performance modifiers.

Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical Dental Vision Life STD/LTD 401(k) Paid Time Off (PTO) or Flexible Time Off (FTO) Tuition Reimbursement and Employee Stock Purchase regularly scheduled to work less than 20 hours Casual Intern and Temporary employees are only eligible to participate in the 401(k) more detailed information pleaseclick here.

• Relocation assistance available.

Labcorp is proud to be an Equal Opportunity Employer:

Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race religion color national origin sex (including pregnancy childbirth or related medical conditions) family or parental status marital civil union or domestic partnership status sexual orientation gender identity gender expression personal appearance age veteran status disability genetic information or any other legally protected characteristic. Additionally all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.

We encourage all to apply

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