Associate Scientist Pharmaceuticals (Chemistry)
Мэтч & Сопровод
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Описание вакансии
TL;DR
Associate Scientist Pharmaceuticals (Chemistry): Developing and validating liquid chromatography methods for small molecules, peptides, and oligonucleotides to ensure purity and safety of therapies with an accent on GMP compliance and rigorous documentation. Focus on authoring protocols, supporting regulatory inspections, and optimizing analytical strategies for process chemistry and formulation teams.
Company
is an independent technology consulting firm providing specialized solutions across Information Systems, Telecom, Life Sciences, and Engineering with a global reach.
What you will do
- Develop and validate U/HPLC assays for potency and stability while managing method transfers.
- Author and maintain technical protocols, reports, and SOPs in a GMP environment.
- Review analytical data ensuring adherence to ALCOA+ principles and regulatory guidelines.
- Partner with cross-functional teams including Process Chemistry and QA to align project strategies.
- Evaluate and implement new reagents and LC technologies to improve workflow efficiency.
- Support regulatory inspections, deviations, and CAPA processes.
Requirements
- BSc or MSc in Chemistry, Analytical Chemistry, or a related field.
- Proven industry experience in liquid-chromatography method development and validation (HPLC/UPLC).
- Strong English documentation skills.
- Familiarity with ICH Q2(R1), USP <921>, and FDA/EMA regulatory guidelines.
Nice to have
- Experience with Chromatography Data Systems such as Empower CDS or Agilent OpenLab.
- Knowledge of LC-MS, IC, or other orthogonal analytical techniques.
- Exposure to stability studies and regulatory filings like IND, IMPD, or NDA.
Culture & Benefits
- Opportunities for rapid career growth in a dynamic, international environment.
- Exposure to prestigious projects across pharmaceutical and biotechnology sectors.
- Work within an agile structure that promotes intrapreneurship and meritocracy.
- Commitment to an inclusive and diverse workplace culture.
Hiring process
- Initial brief call to understand motivations and alignment.
- Approximately three rounds of interviews with team members and management.
- Potential case study or technical assessment task.
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