Product Characterization Scientist (Immunoassay)
Perform analysis of testing performed within the Product Characterization Laboratory. May act as subject matter expert in bioassay development for studies performed in the Product Characterization laboratory. Will develop/validate and perform GMP methods. Oversee a wide variety of safety testing required to manufacture clinical and commercial products. The Scientist will be the primary scientific resource for a given study with the Product Characterization lab within the overall Biologics department. Responsible for making observations and ensuring all documentation is in compliance with procedures and regulations.
Responsibilities will include but are not limited to: Provides day to day technical support to the laboratory; Performs analysis and interpretation of data; Prepares/ reviews technical specifications and final reports; May serve as study director/study management and ensures timely initiation and completion of all studies; Participate and/or drive assay development/ assay transfer and/or assay validation activities; Responsible for resolving deviations/ completing event records; Liaise with Quality Assurance and appropriate cross-functional departmental areas to close the events and corrective actions identified during GxP laboratory testing; Responsible for creating revising SOPs, laboratory records and other related documentation; Contributes ideas and suggestions to improve standard laboratory techniques, protocols, processes and equipment; Provide technical advice and support for internal and external interactions such as client and regulatory audits/inspections, meetings, teleconferences; Promote a culture of continuous improvement within Biologics; act as champion on initiatives and/or projects to drive improvement in quality and / or client service; Contributes/ authors scientific publications and presents at conferences/ seminars.
Who You Are:
· Ph.D. in scientific discipline (i.e. Biology, Biochemistry, etc.) with 2+ years of related experience in a laboratory environment – OR – Master’s degree in scientific discipline (i.e. Biology, Biochemistry, etc.) with 4+ years of related experience in a laboratory environment – OR – Bachelor’s degree in scientific discipline (i.e. Biology, Biochemistry, etc.) with 6+ years of related experience in a laboratory environment
· Relevant working knowledge and experience in scientific discipline executing and overseeing technical projects and/or related studies
· Experience leading and/or mentoring staff in a laboratory setting
· Experience with some or all of the following technical disciplines;
· Development, optimization and/or troubleshooting of the following assays
· Cell-based bioassays
· Surface Plasmon Resonance (SPR)
· Flow Cytometry (potency, titer, viability or identity)
· Western blots
Job Requisition ID: 199676
Career Level: C - Professional (1-3 years)
Working time model: full-time
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.
Job Segment: Biochemistry, Scientist, Laboratory, QA, Science, Research, Quality