A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 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 Biology and Chemistry Manager/ Sr. Supervisor who will be responsible for leading all aspects of biological and chemical assay activities to support client processes and manufacturing activities, ensuring compliance with the established SOPs, cGMP, and all regulatory agencies. He/she will need to provide leadership at all levels of the organization as well as communicate and embody the company vision and values.
This role will be overseeing Biology and Chemistry team performing method feasibility, method qualification/validation, raw material qualification, raw material testing, stability testing, in-process testing associated with the production of our products. The candidate must possess a deep understanding of the pharmaceutical development processes from pre-clinical development through the life-cycle management. The selected candidate will be fully engaged with cross-functional teams seeking to develop new chemical and biological assays to support and enhance company’s assay platforms.
As Biology and Chemistry Manager/ Sr. Supervisor, you will maintain and drive comprehensive quality metrics associated with testing related to our contract manufacturing business, including developing and driving appropriate Key Performance Indicators (KPIs) managing timelines and working with various stakeholders to successfully deliver client deliverables, while helping to maintain our production environment in a state of readiness. You will effectively lead, track and trend the Biology and Raw Material Program at the Carlsbad site as well as initiate and drive change for the site while interfacing with internal and external clients and develop a best-in-class Biology and Chemistry team.
This role will also be the primary scientific resource and Subject Matter Expert (SME) for the Biology and Chemistry team for the site. He or she will be the primary expert in providing technical advice and support for internal and external interactions during client and regulatory audits/inspections, meetings, and teleconferences. The role will entail operating in a fast-paced, highly dynamic environment with key company work partnerships, including both internal and external stakeholders.
ESSENTIAL JOB FUNCTIONS
- Lead, manage and develop the Biology and Chemistry team to support the daily operations of the Manufacturing and Process Development group
- Ensure QC labs compliance with ISO, FDA, cGMP, EMA and Millipore requirements
- Develop and report on Quality metrics for the Biology and Chemistry testing (raw material and in-process testing). Ensure that those metrics are met, that lab performance is continually improving, and that metrics are communicated periodically throughout the site
- Perform analysis and interpretation of data generated by the team. Prepare/ review protocols and final reports as needed
- Support/ participate in new product transfers into Manufacturing. Provide strong technical leadership, expertise and specialized knowledge in test method feasibility/qualification, component qualification, raw material sampling plans and adherence to the Product Development Process (PDP)
- Drive implementation of new services. Keep abreast of potential new technologies to enable the design of new assay and test methods
- Liaise with Quality Assurance and appropriate cross-functional departmental areas to leverage knowledge and experience not being available in house
- Create/Revise SOPs, laboratory records and other related documentation as needed
- Maintain fluency with evolving global regulatory requirements and industry standards for analytical testing and characterization of biological products
- Responsible for coaching employees, determining employee’s responsibilities, performance review, and development plans
- Coach/ train employees on developing, improving and enhancing day to day laboratory techniques
- Build up the company by recruiting, interviewing, hiring, training, and mentoring new talent
- Promote a culture of continuous improvement within Method Development and Quality Control; act as champion on initiatives to drive improvement in quality and client services
- 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 PhD preferred.
- Minimum of 5 years of working experience in Quality Control and CMO
- Previous eadership/supervisory experience is required
- Proven ability to establish direction and obtain commitment to ensure that projects are completed by deadlines and streamlining processes to maximize productivity
- Excellent communication, organization, analytical and technical writing skills
- Working knowledge of validations, calibration systems, process design, design of experiment, instrumentation, automation, and digitization/paperless system
- Operational knowledge of the regulation (cGMP, ISO, EMA) and directives, and liability for non-compliance
- Possess understanding of group dynamics and have the ability to effectively influence group decision-making process. Ability to make thoughtful, integrated, timely and meaningful recommendations and/ decisions and take corresponding actions
- Strong oral and written communication skills, discretion and confidentiality required to interface with sensitive employee relations
- Ability to analyze past and current data/trends and recommend objectives/directives to improve productivity and increase efficiency
- Thorough knowledge of method development, qualification and validation and method transfer principals
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
- Occasionally stand for extended periods of time, up to four (4) to five (5) hours/time
- Occasionally required to lift up to fifty (50) pounds
- 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 lab 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.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
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