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.
We are seeking an experienced and highly skilled MSAT Scientist with deep expertise in bioconjugation processes, including Antibody-Drug Conjugates (ADCs) and Antibody-Oligonucleotide Conjugates (AOCs), to support our clinical and commercial manufacturing operations. This position plays a critical role in bridging process development and GMP manufacturing, ensuring successful tech transfer, process robustness, and manufacturing readiness for highly potent and complex biologic-drug conjugates.
Responsibilities - Adhere to all GDP, GLP, and cGMP requirements as well as Abzena policies, procedures, and mission while fulfilling duties, responsibilities, and tasks.
- Display understanding of USP, 21 CFR, and ICH guidelines.
- Serve as the MSAT subject matter expert (SME) for bioconjugation processes including ADCs and AOCs across early development through commercial lifecycle stages.
- Provide technical leadership for tech transfer from process development to GMP manufacturing, including facility fit, risk assessments, and process scale-up.
- Drive Technology Transfer into cGMP Manufacturing from internal or external process development teams
- Author and revise GMP-compliant batch records and master batch production documents for early-phase, late-phase, and commercial programs.
- Draft addition GMP documents including: BOMs, Specifications, SOPs, Tech Transfer Documents, PFDs, and P&IDs.
- Lead or support process investigations, deviations, CAPAs, and root cause analysis related to conjugation, UF/DF, and chromatography operations.
- Provide in-person and real time manufacturing production support required for project success.
- Drive continuous improvement initiatives related to process robustness, documentation, and manufacturing efficiency.
- Design and implement process characterization, scale-up, and control strategies in collaboration with PD, Manufacturing, and QA/QC teams.
- Maintain a strong working knowledge of cGMP raw materials, consumables, assemblies, in-process materials, designs, and part numbers to complete detailed cGMP records.
- Participate in or lead PPQ campaigns, including planning, execution support, and regulatory documentation contributions.
- Support regulatory inspections, client audits, and due diligence as the MSAT technical lead.
- Contribute to cross-functional project teams to deliver clinical and commercial batches of bioconjugates on time and within scope.
- Demonstrates technical proficiency, scientific creativity, and collaboration with others.
- Operate to the highest ethical and moral standards.
- Ability to multi-task, supporting multiple projects simultaneously ensuring all deadlines are on budget and on time.
- Discuss and present manufacturing campaign data and analysis to internal project teams and respective clients
- Perform other duties as assigned.
Required Qualifications - PhD or MS in Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related discipline
- 5+ years of experience in biopharma MSAT or technical operations, with a focus on ADC and/or AOC processes.
Knowledge Proven track record in both development and commercial-stage support, including batch record authorship and process documentation. Working knowledge of GMP operations, including manufacturing floor support, deviation resolution, and change control. Knowledge and skill with aseptic technique required: BSC Operations, and aseptic processing, including welding/sealing and/or single use sterile connectors Hands-on experience with conjugation chemistries, tangential flow filtration (TFF), Protein A, ion exchange (IEX), and hydrophobic interaction chromatography (HIC). Strong understanding of Microsoft Office Suite including basic functions and graphing within Microsoft Excel Familiarity with semi/fully automated manufacturing equipment Proven ability to troubleshoot bioprocess operations and equipment. Understanding of relevant analytical, processing, and scale-up calculations. Proven ability to build, modify, and utilize digital data storage, visualization, and analysis systems/tools. Strong interpersonal and communication skills, with the ability to interface effectively with cross-functional teams and clients
Preferred Qualifications - Experience with Contact Manufacturing Company (CMC)
- Experience with high-potency APIs and handling OEB 4-5 level materials.
- Familiarity with process validation (PPQ), commercial tech transfer, and lifecycle management.
- Understanding of ICH, FDA, and EMA regulatory expectations for complex biologics and bioconjugates.
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.
