Senior Analytical Scientist

2 weeks ago

Ada, Ohio, United States AmplifyBio Full time

Are you driven by a desire to enhance the future of healthcare? At AmplifyBio, we recognize that our employees are our greatest asset.

AmplifyBio stands as a premier contract research organization, offering a wide array of services that encompass everything from partnering in discovery stage R&D to serving as a preclinical CRO conducting safety, efficacy, and toxicology studies for both small molecules and advanced therapies. Recently, we have expanded our capabilities to include manufacturing services for cell, gene, and mRNA-based therapeutics.

The AmplifyBio ecosystem consists of three specialized business units: ADOC (South San Francisco, CA) – Amplify's Discovery, Optimization, and Characterization laboratories; ASET (West Jefferson, OH) – Amplify's Safety, Efficacy, and Toxicology Site; and the newly established AMEC (New Albany, OH) – Amplify's Manufacturing Enablement Center.

About ASET West Jefferson, OH: AmplifyBio's safety, efficacy, and toxicology unit (ASET) was established as a preclinical CRO in 2021, emerging from Battelle to meet the evolving demands of commercial entities developing contemporary therapeutics. With decades of expertise, AmplifyBio is equipped to handle a diverse range of GLP and non-GLP studies across various in vivo models and dosing routes. A significant investment has been made in constructing a cutting-edge analytical laboratory, featuring molecular and immunological assays that evaluate crucial safety and efficacy indicators for cell and gene therapies during preclinical evaluations.

Position Overview: We are currently seeking a Scientist/Senior Scientist to enhance our Analytical Sciences team.

The Scientist/Senior Scientist will play a pivotal role in developing and qualifying methodologies for cellular and/or molecular biology analysis platforms. The specific title and level will be determined based on the candidate's experience, reporting directly to the Director of Analytical Sciences.

Key Responsibilities:

  • Lead the development, qualification, optimization, and validation of methods to support nonclinical studies involving cellular or molecular biology analytical requirements.
  • Oversee laboratory operations and provide training to laboratory personnel in standard procedures for data collection, analysis, and interpretation.
  • Deliver regular updates on project progress, including any technical challenges encountered.
  • Draft Standard Operating Procedures (SOPs), technical method reports, and sample analysis reports, incorporating result interpretations.
  • Ensure timely completion of reports and departmental deliverables.
  • Collaborate with other analytical scientists to achieve departmental objectives.
  • Present findings during departmental meetings.
  • Maintain compliance with all regulatory and health/safety protocols through ongoing training.
  • Develop innovative platforms and processes that align with corporate strategies.
  • Publish research findings and present at scientific conferences as required.

Qualifications:

  • Doctoral degree in Molecular Biology, Biochemistry, Immunology, Molecular Genetics, or a related discipline.
  • A minimum of 3 years of relevant experience in developing and executing cell or molecular assay techniques (e.g., qPCR, dPCR, cytokine analysis, ELISA, PBMC isolation, flow cytometry).
  • Strong documentation, organizational, communication (both oral and written), multitasking, and problem-solving abilities.
  • Capability to work independently as well as collaboratively within a team environment.
  • Adherence to regulatory requirements to ensure accurate recording and verification of experimental data.
  • Ability to operate in a BSL-2 research laboratory setting, including periods of bench work and working within a bio-safety cabinet.
  • Willingness to receive immunizations with licensed and FDA-approved vaccines and medications for occupational exposure risks.
  • Flexibility to accommodate non-standard work hours as necessary.
  • Willingness to work beyond 40 hours a week (including weekends and holidays) when required to meet project needs.
  • Familiarity with the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) Regulations, 21 CFR Part 58 for conducting nonclinical laboratory studies.

Why Choose AmplifyBio?

At AmplifyBio, we prioritize the health and well-being of our employees and continuously seek ways to enhance our benefits, creating an exceptional workplace. Our offerings include:

  • Health, Dental, and Vision insurance effective from day one.
  • Competitive compensation packages.
  • A commitment to work-life balance supported by a flexible PTO policy.
  • Generous paid parental leave.
  • Wellness and self-care initiatives.
  • 401(k) matching.
  • Tuition reimbursement programs.
  • Employee Assistance Programs (EAP) and work-life support.
  • A vibrant work environment where every voice is valued.
  • An Opportunity to Make a Difference.

Joining AmplifyBio means engaging in groundbreaking work alongside clients, research scientists, study directors, lab technicians, and specialists across various fields. The future of AmplifyBio is shaped by our collective imagination and actions, and we hold ourselves accountable for our decisions and outcomes, with a strong emphasis on action, excellence, and the health and safety of our workforce.

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