Senior Specialist, Small Molecule Analytical Research and Development - Onsite

MSD•Rahway, NJ

3d•Onsite

About The Position

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 suppliesIn 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 Company's research portfolio.

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.
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.
Strong lab OOS investigation and trouble shooting skills.
Accountability
Adaptability
Analytical Chemistry
Clinical Research Organizations (CRO) Management
Data Analysis
Data Review
Experimentation
GMP Compliance
Lab Equipment Maintenance
OOS Investigations
Raw Material Testing
Regulatory Compliance
Release Testing
Scientific Research
Specification Documents
Statistical Analysis
Strategic Planning
Teamwork
Technical Writing
Testing Methodology
U.S. Pharmacopeia (USP)

Nice To Haves

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 techniques.
In addition, experience with electronic notebooks and SAP QN are also a plus.

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.

Benefits

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 https://jobs.merck.com/us/en/compensation-and-benefits.

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