Associate Director of Pharmaceutical Development

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JOB DESCRIPTION

Our client, a leading biotechnology company, is currently seeking a driven and ambitious Associate Director of Pharmaceutical Development to join their team. This is a unique opportunity for a highly motivated professional who has a go-getter attitude.

1) Provide strong technical leadership and activity management with CROs and CMOs to ensure API, drug product and related packaging operations are maintained in compliance with current GMP and regulatory requirements
2) Design, analyze, and coordinate scientific formulation and process studies for the development of clinical and commercial products
3) Provide pharmaceutical support for lead identification and optimization, and formulation support for preclinical and clinical studies
4) Oversee formulation studies, process development, technology transfer, and validation protocols and processes for formulation of cGLP and cGMP production
5) Write CMC documents needed for regulatory submissions
6) Establish appropriate specifications (API, DP, excipients and components)
7) Author and/or manage the assembly of expertise specific CMC sections of regulatory filings in consultation with CMO/CRO laboratories and/or manufacturing facilities
8) Interact with discovery and regulatory affairs and prepare pharmaceutical development package for IND submissions or IND updates
9) Write, review and approve technology transfer and process validation protocols and reports
10) Perform other duties as assigned

CRITICAL REQUIREMENTS

  • 1) A university degree is required (preference will be given to those with degrees in a relevant field, though all candidates are welcome and encouraged to apply)
    2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
    3) Recent experience in the biotechnology industry is strongly preferred
    4) Preference will be given to people with recent experience in drug development

    This position is critical to the team and requires a qualified individual to fill the role... someone with a real go-getter attitude!

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: