Sr./Scientist, Quality Control Bioanalytical at AmplifyBio

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 AMEC New Albany, OH: AmplifyBio's Manufacturing Enablement Center provides customizable cGMP suites to enable advanced therapy manufacturing in a "hoteling model," traditional contract development and manufacturing (CDMO) or a hybrid model. Partnering with AmplifyBio for manufacturing cell therapy, gene therapy, mRNA, plasmid, or other modality is quite different from a typical CDMO experience. The goal is to provide flexible solutions customized to client needs while bringing full expert partnership. At AmplifyBio drug developers will find an innovation-rich ecosystem designed to advance a diverse range and class of pharmaceutical products across development stages.

AmplifyBio is seeking to hire a Sr./Scientist,Quality Control Bioanalytical to join our growing team

The Sr./Scientist,Quality Control Bioanalytical is responsible for the development, optimization, qualification and validation of analytical procedures or transfer of client's analytical procedures used in Quality Control Bioanalytical operation for product release, stability, and process characterization. As a senior member of the QC team, the Sr./Scientist is the analytical sciences subject matter expert for QC and interfaces with Analytical Development/R&D groups. Also, as a senior member of the QC team, the Sr./Scientist sets a high standard by example for the day-to-day operations to ensure the QC laboratory complies with all regulatory requirements.

What You'll Do Here:

• Lead Analytical Development projects and coordinate with R&D groups and Clients to develop robust and fit for purpose analytical procedures focused on HPLC and/or LC-MS technologies that meet the needs the client or internal groups.
• Write and collaborate with the QC team to execute protocols for analytical procedure development, qualification/validation, and technology transfer, and then draft/review written reports.
• Perform routine and non-routine biological, biochemical, and chemical test methods for product in process, lot release, and stability purpose.
• Set the example for QC colleagues to work in accordance with guidelines and requirements established by FDA Good Manufacturing Practices (cGMP), Good Documentation Practices (cGDP), Code of Federal Regulations (CFR), and other applicable regulatory guidance.
• Contribute to the QC laboratory maintenance and the lab operations systems. Also, work with QC management to promote the continuous improvement of QC 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 QC department.

We Would Love to Hear from You If:

• Bachelor's degree in biological sciences, biotechnology, or related field of study with minimum 10 years of experience in a related fieldor a graduate level degree with 5 years of relevant experience.
• Minimum 4 years of experience in a QC laboratory operation or analytical development role in a regulated laboratory operation.
• Highly experienced and knowledgeable biological science laboratory professional with in-depth knowledge of HPLC and/or LC-MS for GMP use, including assay qualification/validation, technology transfer, and troubleshooting.
• Expected to maintain rigor and high quality of execution and documentation required by GMP 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, batch records, and regulatory documentation to support clinical development.
• 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. Therefore, 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 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.
• We are just getting started! More benefits on the way!
• 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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