Senior Scientist - Small Molecule, Analytical Research and Development (Onsite)

Job Description

Senior Scientist, Small Molecule Analytical Research & Development

The Small Molecule Analytical Research and Development group has an opening for a Senior Scientist based in West Point, PA. 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 Senior Scientist, you will be part of the GLP Analytical team developing innovative analytical methodologies for early programs with application to a broad array of drug product dosage forms, combination products and modalities through analytical characterization and data analysis. Your main responsibilities, which are in no particular order and are by no means complete, include:

Primary Responsibilities

• Support execution of Good Laboratory Practices (GLP) activities such method development to support development of pharmaceutical non-clinical formulations using traditional analytical tools

• Contribute expertise and creativity to the collective knowledge and aid in solving complex problems.

• Experience in LC (e.g., RP, SEC, IEX) and spectrophotometric analysis of various biologic modalities

• Directly contribute to experimental design, execution, and data interpretation for GLP project support.

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

• Conduct project management and/or scientific oversight of studies performed at Clinical Research Organizations (CROs)

• Validate and implement analytical methods to support release and stability testing of non-clinical materials under GLP settings.

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

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

• Collaborate with internal stakeholders and partners such as our Research & Development Division QA Research Quality and Preclinical Development.

• Support internal and external compliance audit activities.

Education Minimum Requirements:

Minimum 0-2 years of pharmaceutical industry experience for applicants with a PhD degree or graduating on or before Spring 2025; 4 years of experience with a MS degree, or 7 years of experience with a BS in Chemistry, Pharmaceutical Sciences, other Life Sciences, or equivalent with analytical measurement and characterization experience.

Required Experience and Skills

A proven record of strong technical problem solving and innovative research experience. Excellent written and oral communication skills, as well as interpersonal skills, are necessary to qualify for this role. Experience in analysis of various biologic modalities (e.g., mAb, antibody-drug conjugates, fusion proteins) in addition to small molecules.

Preferred Experience and Skills

Though not required, the ideal applicant would have hands-on experience in GxP Operations, advanced chromatographic separation science and other analytical techniques. In addition, experience with LIMS, Empower, and data science are also a plus. Understanding of protein degradation mechanisms and link between analytical methodologies for analysis is a plus.

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NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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