Sr. Scientist, Pharmaceutical Analytical Sciences

Job Description

GMP Senior Scientist, Pharmaceutical Analytical Sciences

The Pharmaceutical Analytical Sciences group has an opening for a Scientist based in Rahway, NJ. Join us and experience our culture first-hand - one of strong ethics & integrity, diversified experiences, exceptional science, and a resounding passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

In your role as Scientist, you will be part of a GMP analytical team working on cross-functional scientific teams to enable novel small molecule, peptide, and oligonucleotide drug development through laboratory-based analytical characterization and statistical data analysis. 

Primary Responsibilities

• Support execution of Good Manufacturing Practices (GMP) activities such as release and stability testing to support development of active pharmaceutical ingredients (APIs), pharmaceutical formulations, and manufacturing processes using both traditional and advanced analytical tools.

• Document the execution, procedure, results, and conclusions of experiments in a detailed and organized manner following SOPs and ALCOA principles.

• Troubleshoot and investigate any challenges associated with the GMP testing through active collaboration with cross-functional project teams and/or Quality stakeholders.

• Validate and implement analytical methods to support release and stability testing of clinical materials.

• Perform data entry, data review, and author analytical reports or data summaries.

• Directly contributes to experimental design, execution, and data interpretation for GMP project support.

• Lead laboratory investigations and deviations including root cause analysis and identification of robust corrective and preventative actions.

• Strong collaboration with Pharmaceutical Analytical Sciences colleagues as well as cross-functional partners such as Global Development Quality, Process Chemistry, and Pharmaceutical Operations.

• Support compliance audit/inspection activities.

Education Minimum Requirements:

• Bachelor of Science degree with, at least, 3 years relevant industry experience or

• Master of Science degree with, at least, 1-year relevant industry experience.

• Degree in Chemistry, Pharmaceutical Sciences, or other Life Sciences.

 

Required Experience and Skills

• Experience working in a fast-paced analytical laboratory utilizing chromatography instrumentation. 

• Excellent written and oral communication skills.

• Interpersonal skills, are necessary to qualify for this role.

• Ability to work in a team environment with cross-functional interactions.

Preferred Experience and Skills

• The ideal applicant would have hands-on experience in a GMP environment.

• Advanced chromatographic separation science, spectroscopy analysis, dissolution testing, and other analytical techniques. 

• Experience with Empower, Electronic Notebooks and leading laboratory investigations is a plus.

#AR&D

Required Skills:

Adaptability, Analytical Development, GMP Compliance, Good Manufacturing Practices (GMP), Laboratory Information Management System (LIMS), Pharmaceutical Sciences, Strategic Thinking, Troubleshooting

Preferred Skills:

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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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a fede