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process development cgmp tech transfer analytical method development drug substance manufacturing📋 Description
- Manage outsourced drug substance process development and manufacturing.
- Oversee raw materials and drug substance for clinical trials.
- Lead process validation and tech transfer to new vendors.
- Support global regulatory submissions and health agency queries.
- Collaborate with QA to ensure cGMP compliance.
- Drive continuous improvement in drug substance manufacturing.
🎯 Requirements
- PhD in chemistry or chemical engineering with 7+ years exp, or BS/MS with 10+ yrs.
- Industrial-scale chemical development experience.
- Experience managing drug substance development, validation, and manufacturing.
- Strong synthetic organic chemistry background.
- Working knowledge of analytical method development and validation.
- FDA/ICH guidelines familiarity; solid cGMP/regulatory knowledge.
🎁 Benefits
- Market-leading compensation
- 401K with employer match
- Employee stock purchase program
- Pre-tax commuter benefits
- Referral program with $2,500 bonus
- Comprehensive health care with 100% premiums covered
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