Senior/Scientist, Dose Formulation & Analysis

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Job description

Are you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join AmplifyBio!

AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for cell, gene, and mRNA-based therapeutics.

The AmplifyBio ecosystem is comprised of three distinct 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 most recently opened AMEC (New Albany, OH) Amplify's Manufacturing Enablement Center.

About ASET West Jefferson, OH: AmplifyBios 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. AmplifyBio 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.

AmplifyBiois 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.

What Youll Do Here:

• 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 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.

We Would Love to Hear from You If:

• 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.

At AmplifyBio, we're committed to growing and empowering an inclusive community within our company and industry. This is why we hire and cultivate diverse teams of the best and brightest from all backgrounds, experiences, and perspectives across our organization.

AmplifyBio is an equal opportunity employer, and we value diversity at our company. We don't discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law.

Why You Will Love Working Here:

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. From a wellness program (did we mention we have an onsite gym with state-of-the-art equipment and ping pong table?), to financial planning and legal assistance, we make sure to take care of our own.

• 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 everyones voice matters!
• An Opportunity to Change the World

When you join our team, you will be a part of groundbreaking work while collaborating with our clients, research scientists, study directors, lab technicians, and specialists across a variety of disciplines. The future for AmplifyBio is as great as the combination of our imaginations and actions, and we hold ourselves accountable for our choices and results. We have a bias for action, excellence, and, especially, the health and safety of our employees.

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