Job Title: Principal Scientists Employer: Sigma-Aldrich Manufacturing LLC, 400 Summit Drive, Burlington, MA 01803 Job Location: Sigma-Aldrich Manufacturing LLC, 3300 South Second Street, St. Louis, MO 63118. Telecommuting is an option. Must spend 80% of time at work site. Job



Responsibilities:



Responsible for surface plasmon resonance (SPR) system implantation. Responsible for the development, optimization, and qualification of SPR assays to analyze therapeutic antibody functionality and potency using Biacore instrument platforms. Accountable for delivering new SPR assay developments, method transfers and validations in a timely fashion and with the necessary scientific and regulatory standards; Responsible for the development, optimization and qualification of ELISA assays to analyze therapeutic antibody functionality and potency to support GMP program; Responsible for analysis and interpretation of ELISA and SPR data, in line with industry and regulatory expectations; Work within the laboratory areas providing hands-on scientific support, training, guidance and mentorship to laboratory based personnel, as required, while ensuring routine and complex client studies are completed on time, to the appropriate scientific and regulatory standards; Keep project teams informed of project status, technical problems or other issues which could impact project or service delivery; Prepare protocols, reports and Standard Operating Procedures (SOPs) in support of method development, qualification and routine assay execution; Act as subject matter expert and technical lead for SPR and ELISA assays within the organization, with responsibility for training colleagues and advising internal stakeholders and clients as required. Participate in meetings and inspections with operational colleagues, clients and regulatory bodies, as required; Support QC scientist, as required, and maintain laboratory records and quality system documentation as necessary; Maintain knowledge of biological therapeutic molecules and industry standard approaches used to characterize and assess quality in all phases of development. Act as point of contact for custom sales enquiries relating to SPR and ELISA assays (both custom and routine); andCoordinate multi-site interaction across Merck KGaA, Darmstadt Germany. Liaise with subject matter experts across sites for integrated projects. Communicate well with all levels of the organization and across functional groups. Job Requirements: PhD in Chemistry or a closely related field and three (3) years of work experience as an Analytical Scientist. In addition, the employer requires the following: (1) Proficiency with Surface Plasmon Resonance (SPR) gained through at least two (2) years of experience; (2) Demonstrated ability with ELISA assay development gained through at least three (3) years of experience; (3) Proficiency with GMP covering biological therapeutic molecules and their applicable regulatory standards (FDA, USP) gained through at least three (3) years of experience; (4) Demonstrated ability training scientists and analysts on ELISAs and SPRs gained through at least one (1) year of experience; (5) Demonstrated ability leading technology and method transfers of ELISAs and SPRs gained through at least two (2) years of experience. All years of experience may be gained concurrently. Academic or industrial experience acceptable. Telecommuting is an option. Must spend 80% of time at work site. This position is eligible for the Employee Referral Program. Applicants can send resumes to Sigma-Aldrich Manufacturing LLC, 400 Summit Drive, Burlington, Massachusetts 01803 (Attn: Req #273883) or apply online at: https://www.emdgroup.com/en/careers/job-search.html?