We’re looking for a candidate to this position in an exciting company.
Independently design, plan and execute complex analytical method development experiments.
Develop and perform HPLC methods (including RP, SEC, IEX etc.) for bio-process development support.
Develop and perform analytical test methods such as electrophoresis, Western-Blot, ELISA, kinetics, endotoxin, and concentration assays.
Develop and perform kinetics studies using methods such as BLI and SPR.
Develop and perform protein characterization studies using LC/MS/MS.
Analyze data and present results in internal and external meetings. Prepare reports for regulatory submission.
Develop protocols and technical reports, ensuring adherence to high technical standards and compliance with applicable regulatory guidelines.
Plan and coordinate deliverables with internal and external stakeholders according to agreed master plans during analytical method transfer and method validation/verification.
Lead and support assigned projects aimed at monitoring and ensuring compliance (e.g. QM, Pharmacopoeias) and improving method performance including trending of analytical performance indicators. Troubleshoot problems and provide actionable recommendations.
Lead and support performance of stability studies
Support audit/inspections with responsibility for analytical validation/transfer topics.
PhD, Masters or Bachelor’s degree in Pharmacy, Biotechnology, Chemistry, or Chemical Engineering.
Strong scientific knowledge with extensive experience of performing and developing analytical method studies in a relevant industrial setting.
E xperience working in a GLP/GMP compliant environment highly desirable.
Strong project management skills with a focus on delivering to timelines and to quality standards.
Excellent interpersonal skills with the ability to build strong relationships across internal and external partners and to communicate complex scientific information.
Ability to work independently and with the flexibility to handle workflow in a fast-paced start-up environment