Sr. Specialist, Research (Onsite)

Job Description

Senior Specialist Small Molecule Analytical Research & Development

Small Molecule Analytical Research and Development (SMAR&D) team has an opening for a Senior Specialist in our SMARD GxP Operations team based in Rahway NJ. The primary objective of the SMAR&D GxP Operations team is to carry out analytical GMP activities partnering across the network to enable clinical your role as Senior Specialist you will be part of a cross-functional team providing analytical support towards release of raw materials and package components. We are seeking a hands-on lab-based scientist to support GMP testing and document creation. The role will work collaboratively with colleagues in Pharmaceutical Operations and Global Development Quality to ensure timely release of raw materials and package components to enable advancement of our Companys research portfolio.

Primary Responsibilities

• Conduct excipient and package component release testing for our Research & Development Division according to cGMPs.

• Document experiments in a detailed manner in compliance with Standard Operating Procedures (SOPs) and Attributable Legible Contemporaneous Original and Accurate (ALCOA) principles.

• Interface with contract laboratories to ensure timely execution of outsourced GMP testing.

• Perform data review of laboratory notebooks and analytical reports.

• Author release specifications analytical reports certificates of analysis investigations/deviation records change records and SOPs.

• Work collaboratively with Development Quality and Materials Management to ensure on-time release testing of our raw materials and package components.

• Troubleshoot and lead any investigations associated with GMP testing through active collaboration with cross-functional project teams and/or Quality stakeholders. Identify appropriate corrective and preventative actions.

• Engage and participate in various internal and external current Good Manufacturing Practice (cGMP) audits or inspections.

• Represent the GMP functional area on a working group team.

Education Minimum Requirements:

Minimum 5 years relevant industry experience for applicants with a Bachelor of Science degree or at least 2 years of relevant industry experience for applicants with a Master of Science degree in Chemistry Pharmaceutical Sciences or other Life Sciences.

Required Experience and Skills:

Excellent written and oral communication skills as well as interpersonal skills are necessary to qualify for this role. Candidates will also be required to work in a team environment with cross-functional interactions.

Preferred Experience and Skills:

Though not required the ideal applicant would have hands-on experience in GMP operations excipient or package component release testing spectroscopy analysis and other analytical addition experience with electronic notebooks and SAP QN are also a plus.

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Required Skills:

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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 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.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

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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.

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