Senior Operations Manager, BioCMC

Labcorp is expanding its global BioPharmaceutical Chemistry Manufacturing and Control (CMC) footprint and is opening a new CMC facility in Mechelen Belgium.

Biopharmaceutical CMC provides independent objective GMP analytical testing for manufactured medicinal products from late discovery through post-market approval on behalf of global clients. With a strong portfolio of clients and over 25 years of expertise the BioCMC team provides advanced characterization method development stability and routine QC release for biologics vaccines ATMPs and a breadth of other complex biomolecules.

With this new laboratory in Belgium we aim to offer a more comprehensive solution and accelerate the availability of new products for patients. The new site has been strategically developed to complement our existing capabilities in York and Harrogate (UK) and Greenfield (US) and introduce a new CMC analytical testing solution for commercial drug products in the European Union (EU).

This expansion is a key milestone in our long-term plan to strengthen support for pharmaceutical and biotechnology partners who rely on Labcorp for complex CMC and regulatory testing services. If you would like to join us and be a part of this exciting journey take a look at the fantastic opportunities we have to offer.

Senior Operations Manager BioCMC Services

Labcorp is seeking an experienced and motivated Senior Operations Manager BioCMC to lead the GMP Operations team at our new CMC facility in Mechelen. This is an exciting opportunity to shape a new site build a highperforming team and play a pivotal role in expanding BioCMC operations in Europe.

In this role you will be accountable for scientific and GMP regulatory conduct of the Operations function at the BioCMC site Mechelen. You will ensure the integrity of the data generated and its reporting on time to our clients.

You will act as key figure in building the Mechelen team defining the overall work culture and ensure the functionality of the site.

As the departments representative you will participate in client and regulatory inspections. As a key point of contact for BioCMC you will support new business opportunities and ongoing client relationships ensuring that operational activities consistently meet agreed timelines and quality expectations.

You will lead and develop the Mechelen Operations team with responsibility for their health safety and overall wellbeing. Collaboration with senior BioCMC leadership will be essential to ensure the site meets strategic and operational objectives.

By monitoring operational performance quality metrics and timelines you will help drive the sites financial performance ensuring efficient and costeffective operations that support BioCMCs broader financial goals.

You will also guide the advancement of scientific capabilities within operations and lead continuousimprovement initiatives across BioCMC.

This is a fully onsite position and includes on-call responsibilities.

Job Responsibilities:

BioCMC Site Leadership

• Review and approval of key documentation for the BioCMC business in Belgium
• Accountable for ensuring all aspects of Health and Safety and Environment are managed according to company policy and local requirements
• Approver / Owner of the site BioCMC business continuity and crisis management plans
• Interact with social council processes as required by local agreements/policies
• Collaborate with the facilities organization for the effective and efficient running of the site and to ensure compliance with statutory regulatory and company requirements.
• Work effectively with the Global Compliance and logistics organization to ensure the site is managed in an efficient manner
• Ensures the site and personnel comply with all required policies and SOPs as required
• Lead in shaping a cultural of CORE Behaviors Framework; ensuring an engaged inspired workforce.

Operational Duties

• Accountable for outstanding operational quality and scientific execution within the department
• In conjunction with senior management establishes and implements the operating policies needed to achieve departmental and company objectives.
• Ensures that studies and projects are completed in compliance with the requirements of customers.
• Ensures operational resources are appropriately applied for the work forecast site and business unit objectives.
• Creates and fosters a continuous improvement environment within the site in respect of quality process and productivity.
• Accountable for the definition maintenance and continuous improvement of metrics
• The Operation Manager will approve laboratory purchases (within limits) and will be accountable for monitoring and controlling costs assigned to general operations of the site

Personnel

• Lead motivate and inspire reportees
• Champion operational and scientific excellence within team and set culture of delivery
• Accountable for recruitment retention development and performance management of all reportees
• The Senior Operations Manager will make business cases for changes in people resource based on forecasting and budget

Scientific duties

• Ensure appropriate scientific support is provided to client service proposal generation process
• To be aware of new scientific developments methodology and regulations relevant to section
• Champion the development and advancement of scientific knowledge and standards within section and promote scientific innovation

Regulatory and Business Development Support

• Accountable for regulatory compliance of the site and to oversee the responses to issues raised following regulatory inspections
• Approval of Standard Operating Procedures applicable to the site and the site master file
• Support the preparation and costing of Client proposals
• Responsible for addressing regulatory issues covering the site with Clients and Regulatory Authorities.
• Oversee the responses to issues raised following Client or regulatory inspections
• Responsible for presentation of facilities/ capabilities of site to clients/regulatory inspectors
• Identifies opportunities for new scientific technological and business initiatives as part of business goals and strategic direction

Minimum Qualifications:

• Minimum Bachelor degree in Scientific field
• Minimum 5 years Senior Leadership experience including Client and stakeholder management in a relevant industry and field.
• 5-10 years of significant scientific background required (GMP QC testing CMC)
• Extensive knowledge and experience of working to GMP regulations
• Excellent knowledge and application of GMP in a QC environment is required.
• Previous experience of Laboratory management
• Fluency in English and Dutch

Preferred Qualifications:

• Higher degree or MBA
• Project management certification
• Prior experience working for a CRO or CDMO or pharma company
• Experience in CMC testing (protein chemistry molecular biology bioassay cell techniques) and late phase to commercial testing.

Additional Job Standards:

• In-depth understanding of the science and practice utilized within the department Knowledge and practice of general health & safety and local requirements
• Excellent communication and interpersonal skills at all levels
• Skilled in leading teams and strong experience of process and system improvements
• Good financial management and budgeting expertise
• Familiar and proficient with IT packages (Microsoft office/sharepoint)
• Mandatory immunizations and screening as required.
• Occasional travel may be required as part of the role
• Role may require some out of standard hours or weekend work including on-call responsibilities.

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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