Job Description

Our West Point Analytical Sciences team ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed, in alignment with our high standards of quality and all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers, we create an interdependent global manufacturing network dedicatedto deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

We are seeking a Senior Specialist that can drive strategic priorities through technical support in our Chemistry Quality Control Laboratories.

Key Responsibilities

• Providing quality and technical support to Laboratory Operations, in their execution of assays for Quality Control testing and direct on-the-floor support.

• Advocating for safety and environmental stewardship.

• Proactively partnering with Laboratory Quality Assurance to ensure compliance in the laboratory in accordance with cGMPs, and GLPs, international regulations and our Company guidelines, policies and procedures.

• Conducting investigations aimed to prevent deviation recurrence, including establishing the root cause, identifying corrective/preventative actions, identifying event scope, and conducting product impact assessment. Where applicable, completing investigational test protocols to determine root cause, product impact, event scope, etc.

• Guiding key projects that require collaboration across functional areas to drive robust processes and continuous improvement. Continuous improvement includes proactive process/assay improvements, investigation Corrective/Preventative Actions (CAPAs), or value capture projects that seek to improve assay robustness, reduce cost, lower cycle times, or improve schedule adherence.

• Actively using and championing the use of Lean Six Sigma (LSS) and our Company's Production System (MPS) tools, both in problem solving and day-to-day operational activities.

• Authoring and updating technical documents necessary for investigations, assay design/definition, engineering studies, change control and validation.

• Independently manage all aspects of assigned projects and run the business activities including decision making, leading laboratory investigations, stakeholder management, issue identification and resolution, understanding of capacity and demand, participating, and driving the tier process.

Education

• Bachelor of Science (BS) Degree in life science, chemistry, biochemistry, science discipline or engineering with five (5) years of experience in a GMP manufacturing environment, people management, pharmaceutical/biological quality, operational, technical, or regulatory function. OR,

• Master of Science (MS) Degree in life science, chemistry, biochemistry, science discipline or engineering with three (3) years of experience in GMP manufacturing environment, people management, pharmaceutical/biological quality, operational, technical, or regulatory function. OR,

• PhD in life science, chemistry, biochemistry, science discipline or engineering.

Required Experience and Skills

• Analytical aptitude, critical thinking skills and ability to apply key concepts.

• Speaks with courage and candor.

• Strong written and verbal communication skills.

• Ability to manage multiple projects/tasks simultaneously.

• Demonstrated collaboration skills including flexibility, inclusive behaviors, and the ability to work in a team environment.

• In-depth working knowledge and application of GMPs/GLPs.

• Technical writing experience (protocols, reports, regulatory responses, etc.)

Preferred Experience and Skills:

• Project management, change execution management and team leadership experience.

• Demonstrated ability to develop and implement innovative solutions to challenges.

• Demonstrated facilitative leadership skills and able to lead teams to deliver results.

• Progressive and demonstrated decision-making responsibility.

• Understanding of theory and/or experience using Chemistry Testing Techniques/Equipment such as: ICP, HPLC, UPLC, AA, pH, Conductivity, TOC, Raw Material Testing (USP/EP/JP), DLS, Dissolution, IC, HPLC-CAD, Melting Range/Point, GC, UV-Vis, NIR, IR

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R331139