Analytical Method Development Scientist I/II

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 Scientist I, AMD, is responsible for supporting development, pre-qualification, stability and testing of a wide range of large molecule focused analytical methods within the Analytical Method Development (AMD) group. Specifically, the individual will test, develop and optimize analytical methods to support process development, in-process monitoring, drug substance and drug product testing, specification determination, stability and other protocols run within AMD. This position is a hands-on bench role that will develop or support development through independent experiments under the direction of functional or analytical team leads or the AMD Director. The Scientist 1 plays a critical role in improving processes and procedures within AMD. Collaborate with QC, QA, Process Development, Project Management, and communicate with Abzena’s clients on clinical stage and commercial therapeutics to improve the lives of patients.

Responsiblities

• Develops analytical methods and conducts non-GMP testing in all phases of development.
• Runs HPLC, HPLC-MS, CE-SDS, icIEF, ELISA Immunoassays, cell-based assays, SoloVPE, Osmolality, Endotoxin, Western blot, SDS-PAGE and other analytical testing of protein therapeutics.
• Runs method pre-qualification studies and other development-related studies.
• Authors analytical test methods, protocols, development and prequalification reports and transfers methods to the Quality Control laboratory.
• Development knowledge of the drug development process, regulatory requirements and guidelines applicable to analytical methods.
• Improve processes and procedures.
• Acts as a team player achieving corporate objectives through active participation in project teams and initiation and maintenance of effective interactions with clients and Abzena sites.
• Communicates scientific data and concepts effectively.
• Reviews and interprets data.

Qualifications

• B.S. degree in a relevant discipline, (e.g., chemistry, biochemistry, biological sciences, bioengineering, etc.)
• Minimum 0-2+ years directly related experience
• Preferred experience in method development/optimization, qualification and validation of analytical methods in areas related to some or all of the following: HPLC separations, HPLC-MS, Isoelectric Focusing, Capillary Electrophoresis, ELISA Immunoassays, Western blots, Protein Titer (HPLC, ELISA and SPR) and other analytical protein characterization methods.
• Preferred experience in analytical method qualification and validation
• Exposure to control strategy of large molecules for drug substance and drug product, phase appropriate regulatory filing strategies in U.S. and outside U.S.
• Experience in cGMP, ICH guidelines, USP and EP compendial methods

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.