The Quality Control department at Alvotech is looking for a dedicated and quality-minded senior specialist, with extensive experience in Analytical method technology transfers, CAPA management, Health Authority response, analytical investigations and scientific oversight.
Scope and responsibility:
- Lead Analytical technology transfer activities between Alvotech and CMOs, ensuring successful method implementation and Lifecycle management of analytical methods.
- Act as the analytical subject matter expert for product testing methods, including chromatography, electrophoresis, compendial, and biochemical techniques.
- Coordinate transfer activities, troubleshoot technical challenges, and drive timely resolution of method-related issues.
- Author and Review transfer protocols, reports, validation
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- Author, review and approve CAPAs, change control, Document change controls, deviation investigation action and associated quality documentation.
- Lead and support investigations related to analytical quality events, including invalid assays, OOS, OOT, and OOE results.
- Lead the preparation of responses, scientific justifications for regulatory and Health Authority inquiries.
- Collaborate with ARD, Regulatory Affairs, Manufacturing, MSAT, and Quality Assurance teams to support product lifecycle management.
- Drive continuous improvement initiatives to enhance laboratory compliance, efficiency, and effectiveness.
- Ensure activities comply with cGMP requirements, internal procedures, and regulatory expectations.
- Perform training of other scientists in Analytical methods and related activities.
- Creates and updates documents for analytical methods
Job requirements:
- Bachelor’s or master’s degree in technical discipline, (e.g., pharmacy, biotechnology, biochemistry, or a related field)
- 5-10 years of experience in Pharmaceutical or Biopharmaceutical industry.
- Proven experience in analytical method technology transfer and product lifecycle management.
- Strong experience in managing CAPAs, Change Controls, Deviations, and complex analytical investigations.
- Experience supporting regulatory submissions and responding to Health Authority queries.
- Expert knowledge within field of expertise such as methods, techniques as well as relevant procedural/process knowledge
- Open to flexible working hours.
- Excellent written and verbal communication skills.
What we offer:
- An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
- The chance to be a part of a global and fast-growing company.
- An international work culture that encourages diversity, collaboration and inclusion.
- Positive, flexible, and innovative work environment.
- Support for personal growth and internal career development.
- Company social events and milestone celebrations.
- Excellent in-house canteen and coffee house.
- Exercise and wellbeing support for full-time employees.
- On-site shower facility.
- Transportation grant towards eco-friendly modes of travel for full-time employees.
- Internet at home for full-time employees.
