Sr Scientist, AMD

Abzena Inc.•Bristol, PA

About The Position

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 Senior Scientist will be responsible for analytical support of scientific development and product development programs. 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. In addition, the senior scientist may function on project teams as the analytical lead scientist from AMD. The Senior Scientist position requires an extensive skillset and knowledge base to enable the successful applicant to operate in a largely independent manner.

Requirements

PhD in chemistry, biology, biochemistry, or related discipline
3 - 5 years relevant experience in the biopharmaceutical industry
Demonstrated track record of independent decision making in areas related to bioassay design, experimental planning, experimental execution and documentation
Knowledge of biochemical theories, applications and relevant techniques supplemented with a basic understanding of standard industry practice and approaches
Experience working with laboratory instrumentation.
Experience with preparing and/or reviewing development reports, qualification protocols, qualification reports and SOPs
Extensive knowledge of USP, ICH, EP, FDA, 21 CFR, and other guidance documents
Experience in biologics or small molecule analytical development
Experience in instrument troubleshooting and maintenance

Responsibilities

Provide development and/or tech transfer of robust and reproducible analytical methods.
Conduct method pre-qualification, data/trend analysis, drafting of analytical test methods and review of qualification protocols and ensuring seamless method transfer to the QC laboratory.
Provide specification and acquisition of critical reagents to ensure rapid method establishment, optimization and timely development.
Serve as an SME with ability to manage multiple projects and provide regular internal and external progress updates.
Design and execute development, optimization, qualification, transfer, validation, and perform routine testing of analytical methods (if required) for protein, and antibody drug conjugate (ADC) compounds.
Sample types may include raw materials, in-process materials, intermediates, APIs, finished products, related substances, stability samples, cleaning verifications, etc.
Analytical techniques may include UV-visible spectroscopy, RP-LC, SEC, HIC, CEX, SDS-PAGE, Western Blotting, HPLC/UPLC, LC-MS, q-TOF, capillary electrophoresis, ELISA, peptide mapping, SEC-MALS, DSC, MFI, DLS, cIEF, CD, Karl Fischer, FTIR, pH, conductivity, osmolality, appearance, etc.
Prepare and review of standard operating procedures (SOPs), analytical test methods, standard work instructions, technical documents, protocols, reports, etc.
Conduct OOS, non-conformance, risk assessment, gap analysis, and root cause investigations and/or assist management with these investigations.
Write deviations, change controls, and CAPAs, and/or assist management with these documents.
Provide documentation of work in laboratory notebooks and logbooks according to organizational GDP policies and adhere to good documentation practices.
Maintain, clean, calibrate, troubleshoot, repair and/or manage third-party analytical and metrology service providers for analytical instruments and equipment.
Adhere to organizational EHS policies and maintenance of work areas in a safe, clean, and orderly fashion.
Peer review analytical data.
Train and oversee laboratory scientists.
Maintain current knowledge of EHS, cGMP, scientific, and technical developments.
Operate to the highest ethical and moral standards.
Comply with Abzena's policies and procedures.
Communicate effectively with clients, supervisors, colleagues and staff.
Participate effectively as a team player in all aspects of Abzena's business.
Adhere to quality standards set by regulations and Abzena policies, procedures, and mission.
Perform other duties as assigned.