Summary
This leading Global Top Pharma is looking for an Analytical R&D Scientist with a strong background in Inhalations (MDI's & PDI's highly desired) to be part of their dedicated Analytical Team. This will be a HIGHLY visible role within the organization. The right candidate will have the opportunity to make a significant impact on the company's pipeline & portfolio and the recognition that comes with it.
Responsibilities:
- SME for analytical methods developing inhalation drug products and tech transfer for commercialized products
- Validate analytical test methods for API's including product packaging/med devices using QbD principles in adherence with US FD, EU, USP, & ICH guidelines
- Execute pre-formulation studies following cGMP & regulatory guidelines
- Support Vendor qualification activities including performing stability studies for new API's & additional material
- Support and collaborate with formulation & process development
- Author, review protocols, and reports related to Analytical Activities, DP development, process validation, control strategy, life cycle management, and comparability assessment.
- Act as the point of contact for tech transfers at CRO's/CDMO's
Qualifications:
- Masters or Ph.D. in Analytical Chemistry (Or relevant Pharmaceutical degree), with 3-5 years of relevant industry experience with Inhalations
- Hands-on experience with metered dose inhaler (MDI) and dry powder inhaler (DPI)
- Strong background with analytical techniques such as: APSD using ACI/NGI, DUSA, NMR, HPLC, UPLC, UV, GC, LC-MS, Viscometer, Karl-Fisher, IR, Particle size analyses, XRPD, DVS
- Excellent writing skills and a strong team player in a collaborative cross functional team environment
Benefits:
- Competitive Annual Bonus
