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Scientist - Immunoassay - Boston

BioAgilytix Boston, 1320 Soldiers Field Road, Boston, Massachusetts, United States of America Req #196
15 August 2022

In this role, you will lead the design, development and execution of bioanalytical experiments to bring new therapies to market. This role is never boring due to our wide variety of clients and broad ranges of therapeutics treating different types of diseases. You’ll work in a milestone driven environment generating data, evaluating the performance of the therapeutic and context of use. Data integrity and quality are important to us, and this role will integrate the expectations in a highly regulated setting.
 

We are looking for candidates who get energized by working with the newest bioanalytical technologies to solve complex challenges. The best candidates are curious and continuous learners, who have experience in a highly regulated environment, where data integrity is expected and honored. You’ll enjoy and crave collaboration with a network of expert scientists, all while welcoming the opportunity to manage multiple projects, sponsors and project timelines. If you are adaptable and able to inspire the best results, then you’ll be right at home here at BioAgilytix.
 

Essential Responsibilities

  • Lead the development and validation of pharmacokinetic (PK) and immunogenicity (ADA) assays for novel protein-based therapeutics
  • Plan and direct experimental design for junior staff
  • Drive bioanalytical projects to align with client timelines
  • Frequent communication with clients to discuss technical details and provide project updates.
  • Advise clients on PK and immunogenicity assay best practices
  • Author documents (methods, SOPs, reports)
  • Statistical analysis of bioanalytical data.
  • Review of documentation

Minimum Acceptable Qualifications
 

Skills:

  • A background in Ligand Binding Assay development and validation, with experience in PK, ADA, or PD (biomarker) Assays
  • A knack for designing efficient and impactful experiments
  • Experience working in a regulated environment, with a thorough understating of Good Documentation Practices
  • Independence, enthusiasm, openness, and adaptability
  • Demonstrated effective communication skills
  • The ability to inspire others to do their best work and drive results
  • Excellent customer service skills (internal and external)

Education/Experience:

  • BS with 8+ years, or a PhD with 5+ years lab experience
  • A thorough knowledge of regulatory guidance’s and industry best practices for PK and ADA assays
  • Demonstrated expertise in Ligand Binding Assay development
  • Advanced capabilities in data analysis, data visualization statistical analysis
  • A thorough understanding of the statistical analysis ADA cutpoints
  • PK, ADA, PD (biomarker) assay development and validation
  • Microsoft word, Excel, MSD workbench, SoftMax Pro, Watson LIMS, JMP, Graphpad Prism
  • GDP, GLP, GCLP, GCP

Work Environment Highlights (Boston)

  • Broad exposure to a wide variety of protein therapeutics (enzymes, gene & cell therapy, multifunctional therapeutic, oncolytic virus)
  • Unlimited opportunities to solve bioanalytical challenges and help bring needed therapies to market
  • Access to a network of expert bioanalytical scientists to collaborate with and grow
  • Exposure to the newest bioanalytical technologies
  • Continued development and growth, international sites exposure and contacts
  • Exposure to cutting-edge bioanalytical technologies
  • Highly competitive healthcare coverage including medical offered through BCBS (HMO/PPO), dental, and vision
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • 401K plan with employer match
  • Free Parking

Other details

  • Pay Type Salary
Location on Google Maps
  • BioAgilytix Boston, 1320 Soldiers Field Road, Boston, Massachusetts, United States of America