Accede Solutions Inc (accedesol.com)

Principal Scientist, Analytical Development

Accede Solutions Inc (accedesol.com) Delaware City, DE
Accede Solutions Inc (accedesol.com)

Principal Scientist, Analytical Development

Accede Solutions Inc (accedesol.com) Delaware City, DE
1 month ago 41 applicants

See who Accede Solutions Inc (accedesol.com) has hired for this role

Responsibilities:

  • Conduct analytical method development, validation, and project support. Identifies technical challenges during analytical method development and performs method troubleshooting.
  • Manage CMO/CRO analytical project resources as required such as contractors and contract laboratories.
  • Manage technical direction of analytical projects; identify key deliverables and next steps and communicate to the team.
  • Responsible for data review, analysis, and interpretation from a variety of sources. Provide accurate summaries and make recommendations to stakeholders with scientific rigor.
  • Identify and implement new techniques and instrumentation to expand internal capabilities.
  • Author and review technical reports, regulatory submissions, SOPs, validation protocols, and other cGMP documents.
  • Performs the assigned analytical tasks with minimum supervision in support of product development and clinical trial materials.
  • Performs activities within the assigned timelines and in compliance with cGXP's, regulatory requirements, and company practices and procedures.
  • Responsible for the design and conduct of studies in accordance with company and regulatory standards to facilitate new product development.
  • Manage day-to-day laboratory activities for analytical equipment, including sourcing consumables, troubleshooting, maintaining equipment and calibrations with various vendors.

Qualifications:

  • Degree in chemistry, pharmaceutics, or related field; advanced degree is a plus.
  • 10+ years experience in analytical method development, validation and drug product development activities regulated by FDA.
  • Working knowledge of standard Office tools (MS Office, MS Project, Excel, Visio, SharePoint).
  • Ability to work well both independently and with a team.
  • Excellent written and verbal communication skills.

#IND123

  • Seniority level

    Mid-Senior level

  • Employment type

    Full-time

  • Job function

    Research, Analyst, and Information Technology

  • Industries

    IT Services and IT Consulting, Software Development, and Financial Services

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