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Scientist, Analytical Chemistry
2 months ago
**About AmplifyBio**
AmplifyBio is a leading contract research organization that provides a comprehensive range of services, including discovery stage R&D work, preclinical CRO services, and manufacturing services for cell, gene, and mRNA-based therapeutics.
The company's ecosystem is comprised of three distinct business units: ADOC, ASET, and AMEC, which offer a range of services, including laboratory operations, safety, efficacy, and toxicology studies, and manufacturing enablement.
**About ASET West Jefferson, OH**
AmplifyBio's safety, efficacy, and toxicology unit (ASET) was launched as a preclinical CRO that spun out of Battelle in 2021 to address the changing needs of commercial organizations developing modern therapeutics.
The company brings decades of experience to accommodate a wide variety of GLP and non-GLP studies in all in vivo models and dose routes. Among the investments that AmplifyBio has made to empower preclinical assessments of advanced therapies is building a new state-of-the-art analytical laboratory to include molecular and immunological assays that assess critical safety and efficacy indicators for cell and gene therapies during preclinical studies.
**Job Summary**
AmplifyBio is seeking a **Senior Scientist or Scientist** in the **Dose Formulation and Analysis (DFA) group** to join our growing team.
The **Sr. Scientist/Scientist** is responsible for the development, optimization, qualification, and validation of analytical procedures and/or transfer of clients' analytical procedures used in Dose Formulation and Analysis operation for dose stability and concentration.
As a senior member of the team, the **Sr. Scientist/Scientist** is the analytical chemistry subject matter expert for dose analysis and interfaces with Study Operations, Vivarium Operations groups.
Also, as a senior member of the DFA team, the **Sr. Scientist/Scientist** sets by example a high standard for the day-to-day operations to ensure the laboratory complies with all regulatory requirements.
**Key Responsibilities**
- Lead Analytical Chemistry Development projects and collaborate with internal and external clients to develop robust and fit-for-purpose analytical procedures focused on Agilent 1260/1290 Infinity II Bio LC Systems with DAD, Fluorescence, and ELSD detectors that meet the needs of the client or internal groups.
- Lead qualifications and validations of new instrumentation for GLP use.
- Write and collaborate with Study Operations and Quality Assurance to execute protocols for analytical procedure development, qualification/validation, and technology transfer, and then draft/review written reports.
- Write procedures for formulation preparation.
- Perform routine and non-routine analytical testing methods using Agilent HPLCs with OpenLab Data Acquisition Software, formulation preparation tasks, or development for use in Safety, Efficacy, and Toxicology non-clinical studies.
- Set the example for colleagues to work in accordance with guidelines and requirements established by FDA Good Laboratory Practices (cGLP), Good Documentation Practices (cGDP), Code of Federal Regulations (CFR), and other applicable regulatory guidance.
- Contribute to the laboratory maintenance and the lab operations systems. Also, work with Quality management to promote the continuous improvement of operations procedures and systems.
- Communicate clearly and concisely, both verbally and in the form of written reports, including contributing to revising laboratory procedures necessary for the operation of the department.
**Requirements**
- Masters degree in chemistry, biochemistry, or related field of study with minimum 10 years of experience in a related field.
- Doctoral Degree with a minimum 4 years of experience in a chemistry laboratory operation or analytical development role in a regulated laboratory operation.
- Experienced and knowledgeable in an analytical chemistry laboratory with in-depth knowledge of HPLC instrumentation for GLP use, including method development, assay qualification/validation, technology transfer, and troubleshooting using DAD/FLD/ELSD/MSD.
- Expected to maintain rigor and high quality of execution and documentation required by GLP and other regulatory agencies.
- The candidate should enjoy operating in an exceptionally dynamic and cooperative environment that is goal-driven to achieve time-sensitive objectives.
- Is highly dedicated to mentoring team individuals, motivating team success, and contributing in a collegial manner to the entire company.
- Able to communicate clearly and concisely, both verbally and in the form of written reports, including drafting and review of protocols, SOPs, sample processing and formulation preparation records, and regulatory documentation to support non-clinical development.
- Must be willing to be immunized with licensed and FDA-approved vaccines and medications recommended for persons at risk to occupational exposures.
- Must have the flexible schedule to accommodate non-standard work hours.
- Must be able to work more than 40 hours a week (including weekend and holidays) as project timelines require to accomplish necessary tasks on a rotating basis.
- Knowledge of Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) Regulations, 21 CFR Part 58 for the conduct of nonclinical laboratory studies.
- Ability to work in a BSL-2 research laboratory environment which includes periods of bench-work, working in a chemical fume hood, working in a biological safety cabinet, and in a non-classified clean room with appropriate PPE that occasionally includes respiratory protection.
- Ability to work in a fast-paced environment and flexible.
**Why AmplifyBio?**
We take the health and happiness of our employees seriously and consistently evaluate new ways to Amp up our benefits to provide an amazing place to work.
- Health, Dental, and Vision insurance that starts on your first day at AmplifyBio.
- Competitive Compensation Package.
- We take work-life balance seriously and we back it up with a FLEXIBLE PTO policy.
- Generous paid parental leave.
- Wellness and Self-Care Programs.
- 401(k) match.
- Tuition Reimbursement.
- EAP/work-life support system.
- A fun work environment where everyone's voice matters.
- An Opportunity to Change the World.
