Senior Analytical Development Scientist

Proclinical is seeking a dedicated Senior Scientist for Analytical Development. This role involves developing and optimising analytical methods to evaluate drug substances and products throughout their development stages. The successful candidate will also coordinate analytical development and analysis work at contract manufacturing organisations (CMOs) and contract research organisations (CROs).
Responsibilities:
Manage the development, qualification and validation of analytical test methods in accordance with regulatory guidelines.
Support, release and stability testing performed in-house and at CROs and direct GMP investigations.
Develop strategies for evaluating and implementing new technologies within Analytical Development.
Support process development, setting of specifications and regulatory filings and responses.
Participate in method troubleshooting and data analysis.
Supervise the work of Assay Development Scientists or Technicians.
Represent Analytical Development in cross-functional meetings/projects with manufacturing, Quality Assurance, Regulatory Affairs and external partners.
Review and approve SOPs, risk assessments, protocols and reports.
Provide regular updates of group activities to senior management.
Skills and Requirements:
Degree in a relevant biological science. Post-graduate degree in biochemistry or related science is preferred.
Experience in a cGMP Quality environment.
Experience working in a GMP testing environment with an understanding of regulatory requirements and trends related to analytics and product development.
Thorough understanding of current regulatory requirements and practical experience of QC testing in support of cGMP operations.
Ability to interface effectively with management and other groups or project teams.
Computer processing literacy and experience in statistical analysis.
Excellent verbal and written communication skills along with good organisational skills.
Interested or know someone who might be? Reach out to ­­­­Ruhee Saleh using the following:
✉️ #####
020 ##### #####
Apply Now:
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. is acting as an Employment Agency in relation to this vacancy.