Director of Quality Control — Lead QC Strategy (Stock Options)

Omeros Corporation; Seattle (WA); Vor Ort; USD 210.000 - 245.000; Vollzeit

Benefits dieser Stelle

Medical insurance

Dental insurance

Vision insurance

Life insurance

401(k) with company match

Paid vacation

Sick leave

Stock options

Incentives

Zusammenfassung

Omeros Corporation in Seattle seeks a Director of Quality Control to lead a growing QC team across clinical and commercial programs. You will define QC strategy, drive instruments, methods, and release testing in compliance with cGMP, and partner with CMC and external partners to ensure product quality.

The ideal candidate has a PhD in a relevant field and 10+ years in QC within biotech/pharma, with strong expertise in analytical method development, validation, and regulatory interactions.

Qualifikationen

• PhD in Analytical Chemistry, Biochemistry, Biology or a related scientific field.
• 10+ years Quality Control experience, preferably with biologics and small molecules.
• Strong knowledge of GMPs, ICH guidelines and quality management systems.
• Experience with analytical method transfer to third parties and regulatory meetings.
• Expertise with stability testing, data trending and expiry setting strategy.

Aufgaben

• Lead Quality Control activities for clinical and commercial products, including in-process and release testing of GMP products.
• Lead and manage QC staff including hiring, developing, evaluating and goal setting.
• Oversee GMP clinical and commercial stability planning, execution, and data analysis.
• Oversee quality control requirements for compliance with cGMP at external CMOs.
• Develop QC strategy in conjunction with analytical methods and manufacturing processes.
• Author/review regulatory filing sections and drive continuous improvement initiatives.

Kenntnisse

QC Leadership

GMP knowledge

Analytical method transfer

Regulatory interactions

Data trending

Stability testing

Process improvement

Cross-functional collaboration

Ausbildung

PhD in Analytical Chemistry/Biochemistry/Biology or related

Tools

MS Office

Word

Excel

Statistical analysis software

Jobbeschreibung

Omeros Corporation in Seattle seeks a Director of Quality Control to lead a growing QC team across clinical and commercial programs. You will define QC strategy, drive instruments, methods, and release testing in compliance with cGMP, and partner with CMC and external partners to ensure product quality.

The ideal candidate has a PhD in a relevant field and 10+ years in QC within biotech/pharma, with strong expertise in analytical method development, validation, and regulatory interactions.