About the role
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 Bioconjugation Process Development Senior Scientist is responsible for leading bioconjugation downstream process development activities to support Abzena Bristol’s development and manufacturing operations.
Responsibilities
* 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.
* Contribute to assigned laboratory operations including instrument and equipment operations, material shipment preparation, consumables procurement.
* Focus on developing downstream conjugation bioprocesses to manufacture conjugated biotherapeutics including antibody-drug conjugates, conjugate vaccines, protein-oligonucleotide conjugates, peptide-protein conjugates, chelator-antibody conjugates, etc.
* Work collaboratively in the development, optimization, and scale-up of bioconjugation reactions, purification steps, and characterization approaches for conjugate biotherapies.
* Hands-on execution of chromatographic purifications (affinity, hydrophobic interaction, and ion exchange chromatography), membrane filtrations (normal and tangential flow filtrations), buffer and solution preparation, conjugation reaction work-up.
* Perform, develop and optimize bioanalytical characterization (HPLC, UPLC, LC-MS, MALDI, MALS, colorimetric assays, etc.) of bioconjugate products.
* Authoring and review of relevant documentation including laboratory notebooks, process development reports, protocols, batch records, SOPs, technical presentations.
* Maintain strong technical understanding of advancements in bioconjugation/bioprocessing through literature searches and review.
* Serve independently as bioconjugation PD technical lead and subject-matter expert for internal and external project communications.
* Management and supervision of technical team line reports.
Qualifications
* A PhD or BS/MS degree in biochemical sciences or bio-engineering with industry experience (>1 year + PhD, >3 years + MS/BS) in biotherapeutic development or bioconjugation.
* Experience in preparative purification of biological molecules (antibodies, carrier proteins, viruses, viral vectors, or other biological molecules).
* Expertise in normal flow filtrations and tangential flow filtrations (TFF, UF/DF).
* Knowledge of strategies for the optimization of bioprocesses and experimental design (DoE).
* Thorough hands-on experience with preparative chromatography systems (AKTA Pilot, AKTA Ready, AKTA Explorer, etc.), and manual or automated TFF skids.
* Expertise with quantitative determination of scalable process parameters for normal flow filtrations, tangential flow filtrations, and preparative chromatographic separations.
* Knowledge of cGMP manufacturing operations and GxP principles.
* Strong knowledge of bioconjugation reactions, techniques and approaches.
* Experience with protein bioanalytical techniques (HPLC, LC-MS, UV-spectrophotometry, etc.)
* Experience with large scale bioprocess equipment (pallet tanks, pumps, biowelders, biosealers, bio-rockers, single-use assemblies).
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.