Sr. Scientist, Analytical R&D (Onsite)

Job Description

Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. We deliver robust scientific data and interpretation that drives the development and commercialization of breakthrough therapeutics. Using innovative thinking, state-of-the-art facilities, and robust scientific methodology, we collaborate to discover the next medical breakthrough.

The Analytical Research and Development, Cell Based Sciences Department in West Point, PA is seeking a Senior Scientist with technical expertise in developing large molecule potency assays. The Senior Scientist is a laboratory-based scientific role tasked with solving complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines to enable development of Vaccines, with a focus on supporting process development, formulation development, and method lifecycle management. In this role, an individual will collaborate with a team of scientists to develop state-of-the-art analytical techniques to enable development of Vaccine candidates.

This position will involve leading laboratory method development to drive understanding of vaccine development, partnering across functions and divisions to strategically apply that understanding to deliver the best analytical science in the process and product will be key to success. In this role, an individual will lead the development of state-of-the-art immunoassay and potency related analytical techniques, such as ELISA, Meso Scale Discovery, Luminex, AlphaLISA, SPR, and BLI. 

The individual should also have a deep understanding of aspects of immunoassay development including antigen and antibody selection, antibody matched pair screening and optimization, binding kinetics, multiplexing and cell-based assays. Experience with Lab automation / DOE / informatics is considered a plus.

The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. Applicants must have effective organizational, multi-tasking, oral/written communications skills, show scientific leadership, and a desire to conduct research and publish. Evidence of strong cross-functional collaboration in an academic or industrial setting is also preferred. 

Applicants must have effective organizational and multi-tasking skills, have demonstrated excellent scientific leadership, and have superior written and oral communications skills. The candidate will be expected to effectively communicate with stakeholders in partner organizations and to management and governance teams.

Education Requirements:

• Ph.D. in analytical chemistry, molecular biology, cell biology, virology, or related field;

• OR M.S. with a minimum of 4 years of relevant experience in Biopharmaceutical Industry;

• OR Bachelor’s with a minimum of 7 years of relevant experience in Biopharmaceutical Industry.

Required Skills and Experience:

• In-depth knowledge and understanding of immunoassay development including antigen and antibody selection, antibody matched pair screening and optimization, binding kinetics, and multiplexing.

• Direct laboratory experience developing analytical immunoassays (e.g., sandwich-based ELISA, multiplexed ELISA) and utilizing antibody binding assays (e.g., Biacore, Octet).

• Demonstrated ability to lead complex experimental design and detailed data analysis concepts related to analytical method development.

• A strong collaborator with excellent oral and written communication skills; ability to work both independently for development of assays and cross-functionally.

• Demonstrated scientific ability through publications and presentations in scientific conferences.

• Excellent verbal and written communications skills.

Preferred Skills and Experience:

• Experience with qualification, validation, and transfer of assays to a GLP or regulated laboratory environment as listed in ICH Q2 and USP<1033>.

• Experience in representing analytical functional area on cross functional project teams.

• Authoring and reviewing internal technical reports, sections of regulatory filings (e.g., IND, BLA) and external scientific publications.

• Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.

• Ability to design, execute and/or direct development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development.<