Dose Formulation Technician

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: 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. 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.

AmplifyBio is seeking to hire a Dose Formulation Technician to join our growing team

The Dose Formulation will work amongst a team of highly trained scientists and technicians with state-of-the-art facilities to support our clients’ preclinical safety, toxicology, inhalation, and discovery research programs. AmplifyBio is rapidly expanding its service offerings related to the discovery, translation, and development of advanced therapies such as gene and cell therapies.

As part of the Dose Formulation and Analysis Team, the right candidate will help support the company’s growing portfolio of service offerings and commercial capabilities through hands-on laboratory-based preparation of cell and gene therapies and pharmaceuticals in addition to assisting analytical chemistry lead in analyzing dose formulations.

This is a unique opportunity to be part of an emerging company bringing innovative technology to advanced therapies.

What You’ll Do Here:

• Maintain receipt and inventory of raw materials and therapies in support of regulated (GLP) studies.
• Formulate new cell and gene therapies, pharmaceutical dosing solutions and suspensions, vaccine/adeno-associated virus (AAV) vector dilutions using aseptic techniques in a sterile, non-classified laboratory in support of research for the FDA approval process using proper Personal Protective Equipment and engineering controls.
• Understands and conforms to relevant Good Laboratory Practices (GLPs), Standard Operating Procedures (SOPs) and Study Protocol requirements regarding all laboratory activities assigned.
• Repackage and sample test materials.
• Ensures all equipment used is routinely maintained and/or calibrated.
• Communicate resource, staffing, and timeline concerns to management.
• Assists with routine functions such as supplying and performing inventory, stocking, material preparation and acceptance testing, process improvement studies and projects.
• Sample accessioning, tracking, and storage.
• Organize, clean, and maintain the facility laboratories in accordance with GLP and ISO guidelines.
• Prepares media and reagent stocks, autoclaves materials, disposes of bio-hazardous waste, maintains supply inventory, and places orders of reagents, supplies and equipment.
• Performs, documents and reviews data according to standard operating procedures and in accordance with Good Laboratory Practice (GLP).
• Ship samples and test materials to designated laboratories or testing facilities.
• Conduct standard and non-standard tasks working alone or as part of a team with guidance of management.
• Ensure that the proper solutions are prepared, that solutions and reagents are not beyond their expiration date, and that the proper paperwork is maintained.
• Assist the Dose Analysis Team with sample processing, HPLC analysis of small molecule compounds.

We Would Love to Hear from You If:

• Bachelor’s degree or higher in relevant field (biology, chemistry, immunology, microbiology) with minimum of 1 year of demonstrable experience in a related field.
• Strong written and oral communication skills.
• A clear understanding of regulatory requirements, including those pertaining to facility and bio-facility safety.
• The ability to be organized, multitask, communicate effectively with a team of diverse individuals, and a desire to learn new skills.
• A strong work ethic and drive to lead process improvements and capability expansion within designated lab areas.
• Schedule flexibility sufficient to accommodate occasional non-standard work hours (some weekends and holidays on rotating schedule).
• Ability to work in a BSL-2 research laboratory environment which includes periods of bench-work and working in a bio-safety cabinet, and ability to wear respiratory protection.

Desired But Not Required:

• Experience in a GxP environment.
• Experience in a sterile environment.
• Experience with relevant equipment, including maintenance and calibration.
• Experience with sample management, including digital inventory systems and organization.
• Experience in analytical chemistry or HPLC instrumentation.
• Able to communicate effectively and professionally in a fast paced, multi-disciplinary environment.

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 everyone’s 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.