Sr Scientist II / Principal Scientist - Drug Delivery Innovation

Great opportunity for an experienced SR Scientist II/Principal to join our Research & Development team. The Scientist will be involved in developing pharmaceutical drug products and drug device combinations for ophthalmic disease. Candidates should be comfortable multitasking across projects and disciplines. Excellent communication abilities, good writing abilities such as drug product development reports, power point presentations, scientific communications. Up to 60-70% time will be laboratory based and rest will be devoted to data analysis, report generation, training, team/project meetings. This is a site based 'essential' position and remote work is only on a need basis. This position is in Drug Delivery Innovations team working on the development of novel ophthalmic formulations compatible with the company's drug delivery device technologies and on the development and execution of the small molecule pharmaceutical development programs.

The successful candidate will be expected to provide leadership in determining and evaluating novel approaches for extended delivery of therapeutics, work independently while also working collaboratively within the group and across functional groups

• This individual is an experienced scientific leader and technical expert in pharmaceutical sciences product development in the areas of:
• Research and product development experience with drug delivery systems: biodegradable polymeric formulations, core/shell zero order release systems, hollow tubing/reservoirs, thermal sensitive gelling system, hydrogels, monolithic tablets - demonstrated with actual product in clinical trials or already on the market
• Experience with intraocular delivery
• Extensive experiences with pharmaceutical combination product development using quality by design approaches to determine and characterize critical quality attributes.
• Acts as a drug product technical expert and provides leadership and solutions for drug substance stability testing, freezing/thawing, drug product formulation, sterilization, filling devices, inspection, and transportation, for combination products within the company and with external contract research organizations.
• Sound understanding or polymer science, general and organic chemistry, pharmaceutical product development.
• Provides method and process development technical expertise to develop novel drug product formulations.
• Experienced in the development and validation of dissolution testing methodologies.
• The individual is also familiar with and/or has direct expertise in analytical methodologies used for the characterization of formulations for potency, biological activity, stability, impurity testing and aggregation profile.

How You'll Get There:

• In-depth knowledge of regulatory requirements for both GMP drug development and Design Control for medical device development.
• Experience with the requirements and preparation of CMC sections of IND and NDA regulatory submissions.
• Provides process development expertise for commercial drug product processing in specific areas such as Sterile processing, Process Characterization, Tech Transfer and Validation. Support commercial drug product manufacturing operations with technical evaluation of scale up, validation, and technology transfer.
• Identification, evaluation and management of contract research and manufacturing organizations.
• Well versed with Operates HPLC, FTIR Analytical Instruments, & Ussing Chamber (Diffusion Cell). Hot melt extrusion, microscopic applications for many aspects of product development.
• Must have a good understanding of Intraocular and general systemic pharmacokinetics.
• Experience and sound understanding of developing sterile products. Knowledge of regulatory requirements in developing pharmaceutical sterile products. Prior demonstration of problem solving, being resourceful, think outside the box and be able to communicate clearly.
• 7 + years of experience in applying fundamental scientific principles to the design and implementation of formulation development.
• Experience with protein drug delivery systems is required.
• Understanding of formulation characterization methods (binding and functional assays) for potency, combined with the experience in developing assays is required, qualifying and transferring assays to QC environment is desired.
• Demonstrated pharmaceutical product development experience through clinical evaluation to marketing approval
• Demonstrated ability to learn (new technologies, methodologies etc.
• Bachelor's, Master's, in Chemistry, pharmaceutical sciences, physical-organic chemistry, chemical engineering, biochemistry or other relevant scientific field.