Associate Director, CMC Manufacturing Sciences & Technology
Our client is a biopharmaceutical company. They have asked us to assist them in a search for an Associate Director, CMC Manufacturing Sciences & Technology
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Ensures that key initiatives that bridge Development and Manufacturing are efficiently and proactively advanced and implemented through regulatory approval.
- Ensures efficient cGMP processes and software systems such that the compliant delivery of product is optimizing delivery of product supply.
- Assists in ensuring the achievement of product quality and production goals. Provides technical leadership during deviation investigations and related cGMP documentation, as necessary.
- Contributes to risk analysis and mitigation plans to ensure product quality.
- Works closely with cross-functional teams to meet product demand and phase appropriate cGMPs.
- Contributes to writing and review of regulatory filings.
- Performs manufacturing trending and data analysis.
- Utilizes project management tools to ensure the timely implementation of process improvements.
- Requires an advanced degree in Chemical Engineering, Biochemistry, Pharmaceutical Sciences or equivalent.
- Must have a minimum of five years of relevant pharmaceutical/biotechnology experience.
- Experience with sterile or aseptic processing, GMP manufacturing and statistical process control is required.
- Experience with cellular or tissue culture products is preferred.
- Experience with cGMP packaging design and vendor management is desirable.
- A detailed knowledge of ICH, FDA, EMA regulations for manufacturing of biologicals is required.
- Must have experience managing suppliers and third-party contract organizations.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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