A career with MilliporeSigma is an ongoing journey of discovery: our 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
The Carlsbad Gene Therapy Viral Vector Manufacturing is a contract manufacturing site that produces drug substance and drug products for gene therapy and oncology applications. We are seeking a qualified Raw Material Qualification Manager who will be responsible for all aspects of the Raw Material and Consumable Qualification & Testing Program. As part of a dynamic Contract Manufacturing Organization, the successful candidate will work with internal and external stakeholders to manage complex timelines, meet customer deliverables and develop a best-in-class Raw Material Qualification program. This position will oversee the team performing sampling, inspection and testing of raw materials and consumables, as well as have oversight of contract laboratories performing testing.
As the Raw Material Qualification Manager, you will develop and drive appropriate performance KPIs, manage internal and external timelines and working with various stakeholders to successfully deliver results that meet customer expectations as well as conform to regulatory requirements. This role is responsible for developing a comprehensive strategy for raw material and consumable testing that meets current compliance requirements as well as ensuring all of the activities within the team follow established SOPs and regulations to support that strategy.
- Leads, manages and develops Raw Material team to support the daily operations of the Carlsbad Site
- Ensure that Quality metrics are met, that performance is continually improving, and that metrics are communicated accurately to enable data-based decision making.
- Performs analysis and interpretation of data in support of events and CAPAs.
- Develop strong working relationships with internal clients and external Contract Laboratory representatives.
- Review/Approve Qualification protocols and reports.
- Support/ participate in new product transfers and the associated raw materials into Manufacturing. Ensures adherence to the Product Development Process (PDP)
- Liaise with appropriate cross-functional departmental areas to determine root cause for non-conformances
- Create/Revise/Approve SOPs and other GMP documentation
- Maintain high level knowledge of lab procedures and assays.
- Contributes ideas and suggestions to improve Quality systems, Compliance and Safety
- Leads internal and external interactions such teleconferences with clients and contract laboratories
- Responsible for employee coaching and development, determining employee responsibilities, evaluating and managing performance as appropriate.
- Identify, recruits, and retain top-notch talent.
- Promote a culture of continuous improvement within Quality; act as champion on initiatives to drive improvement in raw material and consumable qualification program and associated areas/tasks
- Comply with company EH&S requirements. Promote a safety first culture.
Who You Are:
- BS degree or higher in a Life Science discipline or equivalent.
- MA/MS or Ph.D in scientific discipline with 6 or more years of relevant experience
- BA/BS in scientific discipline with 8 or more years of relevant experience
- Minimum of five (5) years of leadership/supervisory experience.
- Minimum of five (5) years of experience in cGMP Quality Control or Assurance environment. CMO Experience is a plus.
- Experience in Raw Material Testing and Disposition, Quality Systems, and Regulatory Inspections
- Strong Foundation in quality systems supporting ISO 9001 certification as well as FDA and EU regulations
- Expert knowledge of governmental regulatory guidelines relating to the testing and manufacturing of biologics and pharmaceuticals
- Experience with Lean Manufacturing and Continuous Improvement concepts
- Strong Interpersonal skills and ability to work with a variety of personalities at all levels within the organization, including external clients and contract laboratories.
- Detail oriented with strong written and verbal communication skills.
- Ability to work independently within prescribed guidelines or as a team member.
ADDITIONAL LOCAL NEEDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties, the employee is:
- Constantly required to sit and reach to use computers and other office/lab equipment
- Constantly required to view objects at close and distant ranges
- Frequently required to communicate with others
Employee frequently works in a professional office environment and production areas with computer equipment, machinery, tools, and moderate amounts of noise and activity. Employee may occasionally be exposed to fumes, airborne particles, chemicals, vibration and biohazardous materials. The work environment is fast-paced and demanding. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct off- shift, weekend, and overtime duties may be required as assigned by the manager of the employee.
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