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Associate Director of Analytical Science

  • LocationCorvallis, OR 97333 - United States
  • Work TypeFull time
  • Positions1 Position
  • Published At:4 months ago
  • Job no: 42326
  • Category: R&D

Job Description

A leading company in the pharmaceutical industry is currently seeking an Associate Director of Analytical Science to join its team. The role will be challenging but also highly rewarding and this leader will be a key voice in the company. For the right executive, this is a fantastic opportunity with great growth prospects. Key duties include:

1) Plan, develop and oversee analytical chemistry projects outsources to contract manufacturing organizations and contract research organizations

2) Develop, review and approve analytical method validation protocols, method transfer, reports, stability protocols, stability data, process validation protocol, specifications and test methods

3) Prepare and review documents for FDA submissions, BARDA communications, internal management reviews and drug substance manufacturing

4) Work closely with the company’s Project Management Team in the reporting of data, study progression and next steps

5) Identify, select and qualify CROs and audit CROs, if needed

6) Manage the conduct of analytical chemistry studies carried out by CROs, including review of protocols, reports and data presentations

7) Evaluate and negotiate proposal and price quote of the projects for stability studies and analytical development works from CROs

8) Compile and present data to internal and external audiences

9) Assist in the preparation of IND, IND amendments, NDA and other types of regulatory filings

10) Review scientific literature to understand current trends in analytical chemistry research, drug discovery, and vaccine development

11) Review FDA guidance as it is released to stay current on the expectations and requirements associated with IND and NDA filings

12) Attend regularly scheduled meetings with the company’s customers, upper management and internal project teams

13) Interface with regulatory agencies, as required

14) Manage direct reports in accordance with the company's talent management practices


Critical Requirements

1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field

2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

3) Recent experience in the pharmaceutical industry is strongly preferred

4) Preference will be given to candidates with recent experience in research and development

If you are qualified and looking to work with a well-established company – one of the top names in the industry – you should not let this opportunity pass by. However, for this Associate Director of Analytical Science role, you must be someone who is experienced and passionate about research and development.

Compensation and Other Details

Base Salary: Highly competitive package, commensurate with experience

  • Published on 04 Aug 2022, 12:44 PM