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An exciting opportunity for a Senior Analytical Development Scientist to join a leading biotechnology company based in a dynamic and innovative industry. This role offers a chance to contribute significantly to the development, qualification, and validation of analytical methods supporting drug substance and drug product evaluations from preclinical through late-phase clinical development, ensuring compliance with regulatory standards.
Working within a collaborative environment, you will play a key role in supporting product release, process development, and characterization, while coordinating analytical activities across external partners such as CMOs and CROs. This position is ideal for a experienced scientist looking to make a tangible impact on cutting-edge biopharmaceutical advancements.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the Senior Scientist, Analytical Development will be varied however the key duties and responsibilities are as follows:
• Manage the development, qualification, and validation of analytical test methods and oversee technology transfer in line with regulatory guidance such as ICH.
• Support release, stability testing, and GMP investigations including root cause analyses, CAPA, and OOS assessments both in-house and at external CROs.
• Develop strategies for evaluating and implementing new analytical technologies within the department.
• Support process development activities, including setting specifications, regulatory filings, and responding to questions from authorities.
• Provide expert input during method troubleshooting, data analysis, and cross-functional meetings with manufacturing, QA, Regulatory Affairs, and external partners.
• As the Senior Scientist, you will supervise Assay Development Scientists or Technicians and ensure timely, quality deliverables.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the Senior Scientist, Analytical Development, we are looking to identify the following on your profile and past history:
• A Degree or higher level in a relevant biological science (e.g., Biochemistry, Molecular Biology, or related fields). Post-graduate qualifications (M.S. or Ph.D.) are highly preferred.
• Proven 5-10 years industry experience, preferably within a cGMP quality environment, with thorough understanding of regulatory requirements related to analytical testing and product development.
• Strong track record of developing methods using analytical techniques such as PCR, Eliza and cell based potency assays.
WHAT’S IN IT FOR YOU?
Joining our client as a Senior Scientist, Analytical Development means becoming part of a forward-thinking organization focused on innovative therapies. You’ll have the opportunity to work on impactful projects within a supportive team, with exposure to global regulatory standards, and contribute to advancing life-changing medicines. Competitive benefits, ongoing development, and a dynamic work environment await you.
Key Words:
biotechnology / analytical development / validation / GMP / regulatory compliance / project management / cross-functional collaboration / biochemistry / CRO / QC testing / process development / LI-DNI
"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career."
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
