Current Opportunities

Associate Director / Senior Manager - Analytical Sciences

Investigates the feasibility of applying a wide variety of scientific principles and concepts to potential inventions, projects and problems. Plans and executes laboratory research. Maintains a broad knowledge of novel principles --- and theories. Makes major contributions to scientific literature and conferences. Participates in development of patent applications. Responsible for managing and developing a team of a 4-6 research professionals. This person will act as project manager and will be the face of the organization as a consultant or spokesperson on specialized projects. Projects require an expertise in advanced analytical principles and theories including tech transfer of analytical methods in the biotechnology industry.

Senior Scientist, Analytical

Conducting or supervising biotechnological testing activities for pre-clinical studies, clinical development, method transfer, process transfer, process improvement, scale-up, and validation.

Understanding test methods, validation, and stability of the biotech products in a GMP environment. Understand test methods, validation and stability of the biotech products in a cGMP environment. Direct laboratory experience with analytical techniques in support of biotechnology products, including HPLC, HPLC-MS, CE, IEX-HPLC, icIEF, SDS-PAGE and SEC. Experience with Protein characterization, ELISA, Peptide mapping and cell-based assays. Direct experience preparing CMC sections of regulatory submissions.

Associate Director, Analytical Development Operational Systems

Position will be responsible for the operational systems within the Analytical Development organization including management of the staff needed to support them. The systems include stability testing, stability systems, IT systems, reference standards systems, metrology systems, resource management, and documentation systems. Responsibilities will include assisting the Director, Analytical Development with the support of late stage projects. This position will serve as a key senior staff member within Analytical Development and will be highly visible within Analytical Development, Pharmaceutical Development and the Quality Assurance organizations.

• Assess system needs of analytical development using input from staff, management as well as internal and external partners.
• Write, review and approve GMP and regulatory documents
• Serve as a key member of the Analytical Development senior staff which, providing leadership and strategy for the development of technology, projects, people, systems, and quality.

Associate Director, Analytical Development

• Coordinate one or more groups activities, each group consisting of a small team of high level individual contributors, or subordinate supervisors, and having a common, discrete, scientific focus of providing analytical support to the Chemical Development and Formulation Development departments.
• Utilizing an expertise in pharmaceutical analysis, along with experience managing analytical scientists, to ensure that suitable methods are in place to support development programs.
• Define the scientific directions of your team and team members, mentoring staff member development and nurturing technological innovation.
• Serve as key contact with other departments involved in the development process (Formulation, Chemical Development, Regulatory, and Quality)
• serve as a key member of the Analytical Development Leadership Team which provides leadership and strategy for development of technology, projects, people, systems, and quality.

Stability Manager

Manager to ensure that the stability studies are properly identified, initiated, tested, reported and analyzed for trend analysis. The Manager will provide feedback on stability studies to respective groups to ensure users are informed in a timely manner to facilitate regulatory submissions and strategic decisions based on the most recent data.

The Manager will also interface with the Pharmaceutical Development and the Technical Operation groups to finalize the stability master plans and provide protocols to the testing labs. The candidate will also ensure that protocols are implemented, testing is executed and data is reviewed and trended. Other responsibilities may include assistance with data trending, writing and updating of SOP’s and ensuring that stability reports are communicated for regulatory submission.

At a minimum, a Bachelor's Degree and at least 8 year of Quality Control experience with emphasis on stability program management is needed.