Research Chemist, Drug Product Operations - Eurofins Alphora
Eurofins Scientific is a world leader in the food, bio/pharmaceutical product testing, as well as environmental laboratory services and one of the global market leaders in agroscience, genomics, discovery pharmacology, and central laboratory services. With over $2 billion in annual revenues and 38,000 employees across 400 sites in 44 countries, Eurofins is a leading international group of laboratories providing an unparalleled range of testing and support services to the pharmaceutical, biopharmaceutical, food, environmental, and consumer products industries and to governments.
Eurofins Alphora is a pharmaceutical research, development and manufacturing organization in the field of active drug substances and synthetic organic chemistry. Alphora’s focus is at the early stage of API Technology Development, developing chemical processes and preparing materials for pre-clinical and clinical studies. As well, Alphora provides transformative process chemistry expertise for later stage programs and niche commercial manufacturing. Alphora has state of the art synthetic R&D labs, analytical services, GMP Kilo Labs, GMP Pilot Plant and supporting QC/QA functions. Please refer to our website for further information on this Eurofins company.
Conduct analytical method development, method validation, method transfer and QC testing to support the activities required to develop, optimize and scale-up of oral (or other) formulations for Drug Product Operations.
· Execute and troubleshoot analytical activities including analytical method development, method validation, method transfer, and sample testing in an R&D and GMP environment.
· Conduct prototype and GMP stability studies in accordance with ICH or other regulatory guidelines.
· Prepare, review and implement protocols, reports and test methods.
· Troubleshoot, maintain and qualify of HPLC, GC, KF and various pharmaceutical laboratory instruments.
· Ensure that all work is performed in compliance with the applicable SOPs, cGMPs and GLPs.
· Promote and maintain safe and healthy working conditions and comply with established safe work practices and procedures.
· Support the Drug Product Operations Team to ensure the timely completion client projects.
· Other duties as assigned.
EDUCATIONAL AND PROFESSIONAL ATTAINMENT
· B.Sc or M.S. degree in Chemistry or related field.
JOB RELATED WORK EXPERIENCE
· 2-5 years’ analytical development experience in the pharmaceutical industry.
· Pre-formulation studies for oral drug products
· Method development, method validation and transfer
· API characterization, solubility, dissolution, stability studies, and excipient screening
· HPLC, GC, KF, FTIR, UV etc.
TIME REQUIRED IN JOB TO REACH EFFECTIVE PERFORMANCE
Time to reach performance effectiveness:
SKILLS AND KNOWLEDGE:
· Pre-clinical and GMP laboratory experience
· Direct experience in Characterization, Solubility, Stability, and Dissolution studies.
· Strong background in analytical method development, method validation and method transfer.
· Knowledge in cleaning method development.
· Experience with techniques such as HPLC/UPLC, GC, KF, PXRD, DSC, TGA, DVS, dissolution, and particle size.
· cGMP skills and knowledge including the preparation of documentation (Standard Operating Procedures, protocol, report and analytical method)
· Clear and professional verbal and written communication skills.
· Communicates well with managers, peers, and clients.
· Background (or knowledge) in pre-formulation studies for oral dosage formulations
· Hands on with a mechanical aptitude
· Client focused
· Quality Focused
· Research Chemist reports to the Head of Pre-formulations, Drug Product Operations
Submit your resume via email: APPLY NOW!
We thank all applicants for their interest, however only shortlisted candidates will be contacted. No agencies please!