Candidates interested in any of the following positions should submit their resumes via email.
Current Job Opportunities
R&D Chemist - Formulation
Purpose of Job:Support multiple research feasibility projects by conducting formulation evaluation and analytical characterization on candidate drug-device systems.
Major Duties and Primary Responsibilities:
• Work closely with formulation, analytical, and process engineering personnel to advance research feasibility projects to successful proof of concept testing
• Support Formulation Scientist on executing all pre-formulation and formulation evaluation activities
• Support Analytical Scientist on executing all analytical characterization work
• Provide technical support for Process Engineering personnel on process evaluation work
• Initiate research study protocol and summarize results in technical report format, if needed
• Participate in cross-functional team activities to advance research project
• Act as equipment owner to ensure the proper functioning of key pieces of R&D instrumentation
• Provide interim written summaries and project presentations to the R&D group, maintain accurate lab notebook
• Support company goals and objectives, policies and procedures
Job Requirements:
Bachelor Degree in Chemistry, Chemical Engineering, or Pharmaceutical Sciences (or equivalent degree in a science discipline) with a minimum of 3 years industrial experience, preferable in pharmaceutical development or drug delivery. Previous experience with polymer science a plus.
Must be highly flexible, a strong team player, excellent attention to details and have a hands-on approach. Experience with DOE and Design Control preferred. Well versed in Microsoft Word, Excel, Powerpoint and Adobe Acrobat. Excellent written and verbal communication/presentation skills needed.
R&D Project Manager
Purpose of Job:Drive and advance drug-device product concepts from research feasibility to clinical testing in a timely and scientifically sound manner.
Major Duties and Primary Responsibilities:
• Lead technical project team with R&D, analytical, preclinical, process engineering, and device design personnel to advance research projects to pre-clinical PoC testing and/or clinical testing
• Be the point person to coordinate logistics for the flawless execution of technical studies
• Be the technical representative to establish project strategy with other functional departments, such as Clinical, Regulatory, Production, Quality, Project Management and Marketing
• Assist the company in tracking the competitive landscape and identifying new product concepts of strategic corporate interests, when needed
• Be the primary project liaison to external partner or collaboration, if needed
• Be responsible as the technical leader to drive evaluation of a variety of new research concepts, if necessary
• Conduct all aspect of Design Control activities to support project advancement
• Provide interim written summaries and project presentations to the R&D group
• Work in compliance with all US (e.g., FDA Guidelines, CFR, GxP) and international regulatory agencies (e.g. ICH Guidelines, ISO Guidelines, EMEA Guidelines)
• Support company goals and objectives, policies and procedures
Job Requirements:
Degree in Engineering or appropriate science background, with a minimum of 5 years experience in medical device product development, or equivalent combination of education and experience. Must have previous experiences with medical devices and/or pharmaceuticals development.
Must be a strong team leader with a hands-on approach and have excellent attention to details. Prior team leadership experience highly preferable. Experience with DOE and Design Control strongly preferred. Well versed in Microsoft Word, Excel, Powerpoint and Adobe Acrobat. Excellent written and verbal communication/presentation skills needed.
Scientist - Research
Purpose of Job:Support initial research feasibility projects by designing prototype systems to meet target performance profile of the product concept and characterize the drug-device combination for transfer into early development phase.
Major Duties and Primary Responsibilities:
• Act as a technical lead to execute research projects, including
a. Conduct background literature surveys and provide written summaries
b. Assemble comprehensive safety packages for all new materials
c. Conduct drug & polymer properties evaluations
d. Develop analytical methods and provide written protocols
e. Design prototype systems to meet target performance profile
f. Work with Process R&D to optimize filling process prior to transfer to early development
g. Assess drug and polymer system stability and suitability for manufacturing
• Collaborate with fellow R&D personnel to advance product concepts into proof-of-concept pre-clinical and clinical testing
• Provide interim written summaries and project presentations to the R&D group, maintain accurate lab notebook; formalize R&D activities in EGR Reports
• Participate in project team to provide technical support
• Support company goals and objectives, policies and procedures
Job Requirements:
Doctoral Degree in Chemistry, Chemical Engineering, or Pharmaceutical / Life Sciences with 0-5 years of experience in pharmaceutical product or medical device development and/or drug delivery, or equivalent combination of education and experience. Previous experience with biodegradable polymers and/or medical devices is preferred.
Must be highly motivated, flexible and a strong team player. Well versed in Microsoft Word, Excel, Powerpoint and Adobe Acrobat. Strong communication, interpersonal, and organizational skills are essential.
