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Attention To Detail
Role Overview:
- Serve as key quality partner for manufactured medicines, ensuring standards for patients are met.
- Oversee end-to-end product quality from clinical development through commercial operations.
Key Responsibilities:
- Review and approve critical documentation like specifications, batch records, and validation protocols.
- Provide quality oversight of contract manufacturers and external partners.
- Lead product disposition activities and support regulatory filings and inspections.
Qualifications:
- BA/BS in Chemistry, Pharmaceutical Sciences, or related field.
- 6+ years progressive GMP experience in pharmaceutical industry.
- Strong knowledge of FDA, EMA, ICH regulations and risk-based decision making.
Praxis Precision Medicines
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders. The company values trust, ownership, curiosity, and results, fostering a culture of diversity and inclusion with a small but dedicated team.