Senior Scientist, Biologics Drug Substance Commercialization Process Analytics

HireLifeScience

West Point (PA)

On-site

USD 120,000 - 180,000

Full time

5 days ago
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Job summary

HireLifeScience in the United States (Pennsylvania) is seeking a Senior Scientist in Process Analytics to lead analytical strategy for a diverse biologics pipeline. You will guide method establishment, support process development, and ensure scientific rigor and data integrity as programs move from R&D analytic teams to BDSC Process Analytics.

You will collaborate with drug substance and drug product teams, oversee new methods, author technical documents, and drive project planning with a focus

Responsibilities

  • Provide insight, guidance, and scientific leadership to the broader team. Serve as a technical leader for the Process Analytics team and support alignment and standardization efforts across programs and stakeholders.
  • Bring strong analytical experience to guide routine testing teams, support troubleshooting, and enable robust data analysis. Identify opportunities to improve efficiency, strengthen methods, and support innovative approaches to analytical problem‑solving.
  • Collaborate closely with drug substance and drug product process teams, broader analytical network, and other stakeholders to ensure integrated support across the product lifecycle.
  • Serve as a point of contact for late-stage pipeline and newly launched commercial programs and support effective testing prioritization across multiple projects and competing demands. Demonstrate strong organizational and project management skills in a dynamic environment.
  • Support and oversee the establishment of new methods within BDSC Process Analytics team, including handoff from research analytic teams to BDSC Process Analytics, ensuring technical readiness for implementation.
  • Author technical protocols, reports, and regulatory documents in support of process comparability studies.
  • Demonstrate excellent ethics, compliance, and integrity while maintaining high standards for scientific rigor, documentation, and team expectations.
  • Provide support and guidance to the lab lead and help foster a collaborative, accountable, and high-performing team culture.

Job description

Job Description

We aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

As a Senior Scientist in Process Analytics, you'll be at the forefront of scientific problem-solving and technical leadership, partnering cross-functionally to support process development, method establishment, and lifecycle activities for a diverse biologics pipeline. Your contributions will help ensure scientific rigor, analytical excellence, and operational readiness as programs transition from being supported in our research & development division analytic teams to BDSC Process Analytics.

Responsibilities
  • Provide insight, guidance, and scientific leadership to the broader team. Serve as a technical leader for the Process Analytics team and support alignment and standardization efforts across programs and stakeholders.
  • Bring strong analytical experience to guide routine testing teams, support troubleshooting, and enable robust data analysis. Identify opportunities to improve efficiency, strengthen methods, and support innovative approaches to analytical problem‑solving.
  • Collaborate closely with drug substance and drug product process teams, broader analytical network, and other stakeholders to ensure integrated support across the product lifecycle.
  • Serve as a point of contact for late-stage pipeline and newly launched commercial programs and support effective testing prioritization across multiple projects and competing demands. Demonstrate strong organizational and project management skills in a dynamic environment.
  • Support and oversee the establishment of new methods within BDSC Process Analytics team, including handoff from research analytic teams to BDSC Process Analytics, ensuring technical readiness for implementation.
  • Author technical protocols, reports, and regulatory documents in support of process comparability studies.
  • Demonstrate excellent ethics, compliance, and integrity while maintaining high standards for scientific rigor, documentation, and team expectations.
  • Provide support and guidance to the lab lead and help foster a collaborative, accountable, and high-performing team culture.
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