Associate Director of Analytical Science

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JOB DESCRIPTION

A leading company in the pharmaceutical industry is currently seeking an Associate Director of Analytical Science to take their team to new heights of success. 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 projects that are outsourced to CROs and CMOs
2) Develop, review and approve analytical method validation protocols, method transfer, reports, stability protocols, stability data, process validation protocol, specifications and test methods
3) Collaborate with team members from CMC, QA, Regulatory, Non-Clinical and Clinical as necessary
4) Prepare and review documents for FDA submissions, BARDA communications, internal management reviews and drug substance manufacturing
5) Work with the Project Management Team in reporting data and study progression
6) Identify, select, qualify and audit CROs whenever needed
7) Manage the conduct of analytical chemistry studies carried out by CROs
8) Evaluate and negotiate proposals and price quotes of the projects for stability studies and analytical development works from CROs
9) Collect and present data to internal and external audiences
10) Assist in the preparation of IND, IND amendments, NDA and other regulatory filings
11) Review FDA guidance to stay in touch with the expectations and requirements associated with IND and NDA filings

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 analytical science management

    For the right leader, this role is a fantastic opportunity to be a key player in the exceptional success of this renowned company. If you are qualified and think this could be you, please apply ASAP!

COMPANY INFORMATION

Sterling-Hoffman is a retained executive search firm that specializes in representing life sciences and technology companies in matters of high impact talent acquisition. Our clients include market leaders and venture capital-backed startups in industries such as: medical device, biotechnology, pharmaceuticals, enterprise software, clinical research, and laboratory services. You may view more of our jobs here: http://www.sterlinglifesciences.com Your privacy is important to us: we will never share your resume without your permission. Please note that only qualified applicants will receive a response. We encourage you to apply for as many jobs as you believe you are a fit for, but strongly suggest that you include your salary information as job seekers who provide salary information are likely to be reviewed sooner. ===================== TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Biotechnology Recruiter, Pharmaceutical Recruiter, Medical Device Recruiter, Biotechnology Career, Clinical Research Job, Regulatory Affairs Job, R&D / Scientist Job, Product Manager Job, Medical Device Sales Job, Biotechnology Sales Job, Quality Assurance Job, Engineering Job, Laboratory Jobs, Microbiology Jobs, CEO Jobs, Marketing Jobs, Manufacturing Jobs, Oncology Jobs, Cardiology Jobs, Hematology Jobs, Medical Jobs

JOB INFORMATION

Seniority Level:
Director / VP
Function:
  R&D / Science
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation: