Requisition ID: QUA009157
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 position is responsible for providing project and technical leadership for the Chemistry Technical Support Services Team. A primary goal of this individual is to provide excellent technical support to the Laboratory Operations area in support of schedule adherence, right the first time, and compliance goals. The Senior Specialist will support key projects for Laboratory Operations aimed at elevating the compliance, assay robustness, and performance of the laboratories. Strong partnership with Laboratory Operations, Laboratory Quality Assurance, Divisional Analytical groups, and manufacturing areas is required.
The Senior Specialist must be an advocate for maintaining a safe work environment and is responsible for ensuring compliance in the laboratory in accordance with cGMPs, and GLPs, international regulations and Merck guidelines, policies and procedures.
This individual is expected to be a subject matter expert in raw materials / chemistry testing and to leverage this expertise to provide guidance for analytical changes, work standardization, and process improvements. The individual in this role will be responsible for designing and driving projects, process improvements, as well as deviation and change management goals. The individual will leverage his/her experience and leadership skills for the development and mentorship of junior group members and peers. The Senior Specialist will utilize his / her communication skills to present complex concepts and results to diverse audiences.
Education Minimum Requirement:
- Bachelor's degree in science, engineering, or related areas of study.
Required Experience and Skills:
- At least 8 years of experience in GMP Manufacturing environment, People management, 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 with a BACHELOR'S degree......OR at least 3 years of experience in GMP Manufacturing environment, People management, 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 with a MASTER'S degree.......OR have a PhD Degree.
- Experience using HPLC-MALLS systems and Astra software
- Experience with analytical instrumentation (ex. MALLS, UPLC, HPLC, LCMS, ICP, IR, UV, AA, and GC)
- Thorough knowledge of chromatography principles and troubleshooting.
Preferred Experience and Skills:
- Experience using CDS systems (ex. Empower and Chromeleon)
- Experience using SAP, LIMS, and Trackwise
- Progressive and demonstrated Quality decision making responsibility
- 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
- Proven analytical aptitude and critical thinking skills
- Demonstrated self-starter with capability to develop innovative solutions to challenges
- Strong written and verbal communication skills
- Comfortable with multi-tasking and working in a fluid environment
- In-depth working knowledge and application of GMPs/GLPs
- Experience in pharmaceutical laboratory operations or related environment
- Experienced investigator and the use of root cause analysis tools (E&CF, Fault Tree, Kepner-Tregoe)
- Speaks with courage and candor
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 email@example.com.
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Visa sponsorship is not available for this position.
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Job: Quality Lab Related
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: None
Company Trade Name: Merck
Nearest Major Market: Philadelphia