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Senior Analytical Scientist
2 months ago
Are you driven by a desire to advance the field of medicine? 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 discovery stage R&D partnerships to preclinical CRO capabilities, including safety, efficacy, and toxicology assessments for both small molecules and advanced therapies. Recently, we have expanded our services to include manufacturing for cell, gene, and mRNA-based therapeutics.
The AmplifyBio framework 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 initiated as a preclinical CRO that emerged from Battelle in 2021, aiming to meet the evolving demands of commercial entities developing modern 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 to evaluate critical safety and efficacy metrics for cell and gene therapies during preclinical evaluations.
Position Overview: We are currently looking for a Scientist/Senior Scientist to enhance our Analytical Sciences team.
The Scientist/Senior Scientist will be tasked with developing and validating methodologies for cellular and/or molecular biology analysis platforms. The specific title and level will be determined based on the candidate's experience and will report 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.
- Maintain a presence in the laboratory to supervise and train laboratory personnel in standard procedures for data collection, analysis, and interpretation.
- Provide regular updates on project progress, including any technical challenges encountered.
- Draft Standard Operating Procedures (SOPs), technical method reports, and sample analysis reports that include result interpretations.
- Ensure timely delivery of reports and departmental outputs.
- Collaborate with other analytical scientists to drive departmental objectives.
- Present findings to the department during scheduled meetings.
- Complete and maintain training to comply with all regulatory and health/safety standards.
- Develop new platforms and processes that align with corporate strategy.
- Publish research findings and present at scientific conferences as necessary.
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 all regulatory requirements to ensure accurate recording and verification of experimental data.
- Ability to operate in a BSL-2 research laboratory, which includes periods of bench work and working in a bio-safety cabinet, as well as the capacity to wear respiratory protection.
- Willingness to receive immunizations with licensed and FDA-approved vaccines and medications recommended for individuals at risk of occupational exposures.
- Flexibility in scheduling to accommodate non-standard work hours.
- Availability to work beyond 40 hours a week (including weekends and holidays) when necessary to fulfill essential tasks.
- Familiarity with the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) Regulations, 21 CFR Part 58, for conducting nonclinical laboratory studies.
Why Work at AmplifyBio?
We prioritize the health and well-being of our employees and continuously seek innovative ways to enhance our benefits, creating an exceptional workplace. Our offerings include:
- Health, Dental, and Vision insurance commencing on your first day at AmplifyBio
- Competitive Compensation Package
- A commitment to work-life balance supported by a FLEXIBLE PTO policy
- Generous paid parental leave
- Wellness and Self-Care Programs
- 401(k) matching
- Tuition Reimbursement
- EAP/work-life support system
- A vibrant work environment where every voice is valued
- An Opportunity to Make a Difference
At AmplifyBio, you will engage in groundbreaking work while collaborating with clients, research scientists, study directors, lab technicians, and specialists across various disciplines. The future of AmplifyBio is as promising as the synergy of our creativity and actions, and we hold ourselves accountable for our decisions and outcomes. We emphasize action, excellence, and, above all, the health and safety of our employees.
