Principal Scientist - AMD
Bristol, PA
Scientific – Analytical Method Development /
Full Time /
On-site
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
The Principal Scientist will be responsible for analytical support of scientific development and product development programs and will have responsibilities for running a functional team within the laboratory. The individual will develop and optimize analytical methods to support process development, in-process monitoring, drug substance and drug product testing, specifications, method qualification/validation protocols and reports. The Principal Scientist may function on project teams as the analytical lead scientist from AMD. The Principal Scientist position requires an extensive skillset and knowledge base to enable the successful applicant to operate in a largely independent manner, with the ability to oversee a group of laboratory scientists.
Responsibilities
- Provide in-depth, hands-on, technical expertise, for the development, phase appropriate validation, transfer and documentation of analytical methods in support GMP small molecule drug-linker synthesis.
- Serve as analytical subject matter expert (SME) for small molecule drug-linker process development (PD) by interpreting, optimizing and troubleshooting PD generated analytical data, establishing in-process controls, assisting in generation of process development reports and preparing and presenting external communications.
- Establish communication channels and maintain consistent, reliable and exceptional communication of analytical data to the small molecule drug-linker PD team.
- Supervise and mentor laboratory staff in all aspects of analytical development operations including laboratory safety, instrument operation and maintenance, method development strategies, method validation strategies, proper documentation and external communication.
- Lead by example and establish the Principle Scientist (SMAD) position as a technical and professional role model for laboratory staff.
Qualifications
- PhD in analytical chemistry or related field with a minimum of 10 years of SMAD industrial experience. Postdoctoral experience may be applicable if in a directly related field.
- Demonstrated thorough understanding of analytical instrumentation, columns (e.g. RP, HIC, IEX) and software (e.g. Waters, Agilent, Varian, Sciex, etc).
- Demonstrated thorough understanding of analytical method development strategies and cGMP method qualification/validation requirements
- Demonstrated thorough understanding of chromatographic theory and application thereof
- Superb, meticulous and disciplined documentation skills and expertise with Microsoft office software
- Excellent communication skills (verbal, written and presentation)
FLSA: Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
