Senior Specialist Vaccine Tech support

Requisition ID: QUA008229 Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. The Senior Specialist, Virology Technical Support position is responsible for providing quality and technical support to a team of Laboratory Managers, Data Analysts and Laboratory Technicians. This individual is responsible for ensuring compliance in the laboratory in accordance with cGMPs, and GLPs, international regulations and Merck guidelines, policies and procedures. The position will also be responsible for the direct technical support of Virology / Cell Culture /Potency assays. The Senior Specialist must be an advocate for maintaining a safe work environment. The individual in this role will be responsible for meeting and driving changes to ensure technical support needs are met including schedule adherence and right the first time execution of testing. The Senior Specialist will be expected to lead the technical support in the area for which they are assigned by providing guidance for necessary analytical changes and strong partnership with Laboratories, Divisional Analytical groups, and manufacturing areas. The Senior Specialist will support key projects for Laboratory Operations aimed at elevating the compliance, assay robustness, and performance of the laboratories within their responsibility. As the direct technical support in the area, the individual is expected to fully manage all aspects of assigned projects and run the business activities, including but not limited to: decision making, stakeholder management, issue identification and resolution, understanding of capacity and demand, participates and drives the tier process, as appropriate, and uses this forum to escalate concerns and best practices. Proactively partners with Laboratory Quality Assurance personnel to ensure compliance with regulations, guidelines and procedures. Ensures that all process improvements and capital projects are timely, robust and in alignment with corporate goals. Qualifications Education Minimum Requirement: Bachelor's degree in science, engineering, or related areas of study. Required Experience and Skills: For candidates with a Bachelor's degree, a minimum of 7 years of experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations or related industry experience in a laboratory, manufacturing, science related or regulated setting. For candidates with a Master's degree, a minimum of 5 years of experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations or related industry experience in a laboratory, manufacturing, science related or regulated setting. PhD Degree in science, engineering, or related areas of study. Preferred Experience and Skills: Progressive and demonstrated Quality decision making responsibility. Familiarity with Live Virus potency assays Project Management, Change Execution Management and Team Leadership experience in a Quality function. Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment. Demonstrated self-starter with capability to develop innovative solutions to challenges. Demonstrated facilitative leadership skills and able to lead teams to deliver results. Proven analytical aptitude, critical thinking skills and ability to apply key concepts. Speaks with courage and candor. Strong written and verbal communication skills. In-depth working knowledge and application of GMPs/GLPs.  Proven ability to manage multiple projects/tasks simultaneously. Experience in pharmaceutical laboratory operations or related environment. Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com. Search Firm Representatives Please Read Carefully: Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Visa sponsorship is not available for this position. For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement OFCCP EEO Supplement Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of it's manifestations. Job: Quality Lab Related Other Locations: Employee Status: Regular Travel: Number of Openings: 1 Shift (if applicable): 1st Hazardous Materials: Company Trade Name: Merck
Salary Range: NA
Minimum Qualification
8 - 10 years

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