BioHealth Job Opportunities
BioHealth Innovation, Inc. (BHI), a Montgomery County innovation intermediary which translates market-relevant research into commercial success by bringing together among other things management, funding, and markets, is seeking an experienced life science professional with entrepreneurial experience to serve as an Entrepreneur-in-Residence (EIR).
Summary of Position:
The Director, Regulatory Affairs is the regulatory representative on the Product Development Teams providing regulatory support and advice. The Director will facilitate regulatory strategy development and implementation, take the lead on regulatory submissions, and author, review, and coordinate quality submissions to regulatory agencies. The Director will prepare for meetings, teleconferences, and other communications with FDA, educate teams regarding regulatory risks and implications for strategy and product development activities, and utilize technical knowledge and effectively apply regulations and guidelines to the product development process.
The Senior Director, AMS provides overall leadership, management, coordination and strategic direction for the ATCC Microbiology Systems business unit of ATCC. AMS is focused on the development of innovative products and reference standards for use in microbiological-based infectious disease research and industrial applications. As a member of the ATCC Senior Management Team the Senior Director, AMS will also have a direct impact on the management of the ATCC organization. The incumbent is responsible for AMS on a P&L basis and will work cross-functionally within ATCC to ensure that business unit revenue goals are met. This position is also accountable for setting developmental program initiatives, creating external partnerships that facilitate ATCC as a go-to partner for biodeposit and standards development, and implementing programs to deliver on agreed objectives for the AMS business unit. The Senior Director, AMS is responsible for the overall success of the product development process within the AMS business unit including the on-time, on-target and on-budget launch of new products.
The Associate Director, R&D directly supports the VP/GM, ATCC Cell Systems in the development, coordination, execution and management of the cell biology-based business unit of ATCC. This includes identification of new areas for cell biology based product development. The incumbent collaborates cross-functionally with business and operational units both within ACS and ATCC to deliver strategic objectives. The Associate Director, R&D is responsible for hiring, developing and managing R&D staff.
Key responsibilities of the position include the design and execution of experimental protocols for developing and qualifying animal-based potency assays, conducting in vitro potency assay development and leading vaccine product stability studies with the company’s Potency Assay Group.
The senior scientist will also support the grant, contract and regulatory document writing and review within the Potency Assay Group, as well as oversee the scientific projects of the Group.
This position is responsible for vaccine potency assay development. The appropriate candidate is proficient in in-vitro bioassay and potency studies in animals, has a strong background in bioassay development and validation, and exhibits excellent problems solving and communication skills.
PathSensors, Inc. is a growing biotechnology company headquartered in Baltimore, Maryland. The company is developing products for the rapidly evolving field of pathogen detection. We are currently seeking qualified candidates for the position of Director of Biosensor Development. The successful candidate will be responsible for design, development and continuous improvement of our portfolio of biosensor products.