Large Molecule BioA Project Scientist-Senior Associate Scientist

Mattawan, MI, USA
Job Description

The Immunology and Immunochemistry disciplines support large molecule drug development using ligand binding assays, such as enzyme-linked immunosorbent assay, to measure large molecules and their immune responses. The main types of assays include Pharmacokinetic assays to measure drug and Immunogenicity assay to measure anti-drug antibodies and neutralizing antibodies. Other assay types also performed are branched DNA and cell-based assays. An array of platforms are used to support these assays that include spectrophotometer, Meso Scale Discovery, Luminex and Gyrolab. Utilizing these platforms/assays, the teams are responsible for the method development, validation and routine sample analysis in both the regulated and non-regulated space of non-clinical and clinical studies.

 Essential Functions: (The fundamental Duties & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed: 

  • Effectively manage a portfolio of sample analysis projects while ensuring timelines are met in a single operational area with oversight

  • Execute review and approval of data with oversight for final scientific/technical decisions within a single operational area

  • Develop understanding of compliance expectations to respond to quality assurance audit observations in appropriate software with oversight

  • Assist with oversight the completion of laboratory investigations, assay troubleshooting and quality observations

  • Assist in problem solving for technical and/or regulatory issues with oversight; Responsible for writing and preparing study plans/protocols/amendments with minimal oversight; Participate in Sponsor visits/tours with minimal oversight

  • Develop expertise in developing and validating quantitative/qualitative methods/procedures with limited complexity/scope in one operational area with minimal oversight

  • Perform data analysis using appropriate software with minimal oversight

  • Develop critical thinking, troubleshooting and time management skills aligned with needs of operational areas

  • Demonstrate effective communication skills through informal discussions with peers, supervisor, and team

  • Function as a liaison, maintaining timely and frequent communication between CRL and Sponsor/Client/SD with minimal oversight

  • Ensure scientific integrity of studies with minimal oversight

  • Function as a Principal Investigator, Individual Scientist and/or Study Director as assigned with minimal oversight

  • Actively communicate and collaborate across operational areas in order to adhere to timelines and produce quality data

  • Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.); Write, review and approve deviations with oversight

  • Develop knowledge of regulatory and GXP requirements, industry standards and company SOPs within one operational area

  • Effectively manage a small portfolio of research projects including method development and validation while ensuring timelines are met in a single operational area with oversight

  • Performs all other related duties as assigned

Desired Skills & Experience

 

  • Bachelor's degree (BA/BS) with 5-7 years of relevant working experience. Master's degree (MS) with 1-2 years of relevant work experience. Doctorate degree (PhD) with no experience

  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above

  • Ability to communicate verbally and in writing at all levels inside and outside the organization

  • Basic familiarity with Microsoft Office Suite; Computer skills, commensurate with Essential Functions, including the ability to learn a validated system

  • Ability to work extended hours beyond normal work schedule to include, but not limited to evenings, weekends, extended shifts, and/or extra shifts; sometimes on short notice

  • Ability to work under specific time constraints

 

Employer
Charles River
Boston, MA, USA