Job Description

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 MSAT Scientist I – Bioconjugation supports the execution, transfer, and ongoing support of bioconjugation processes, including ADCs and AOCs, within a cGMP manufacturing environment.

This role focuses on technical execution, documentation, and on-the-floor manufacturing support. The Scientist I works under guidance from senior MSAT staff and contributes to ensuring processes are accurate, repeatable, and compliant.

Responsibilities

• Follow all cGMP, GDP, GLP, FDA, and ICH requirements and internal procedures.
• Support technology transfer activities from Process Development or external partners into manufacturing, including document review and execution readiness.
• Assist in authoring and revising batch records, SOPs, BOMs, and other GMP documentation.
• Provide on-the-floor manufacturing support during batch execution, including troubleshooting under supervision.
• Support deviation investigations, root cause analysis, and CAPA implementation with guidance from senior staff.
• Assist with data collection, trending, and analysis to support process performance and continuous improvement.
• Participate in process characterization and scale-up activities.
• Support preparation and execution of PPQ and validation activities as assigned.
• Maintain knowledge of raw materials, consumables, and single-use assemblies used in manufacturing.
• Assist in development of training materials and process documentation updates
• Support cross-functional collaboration with Manufacturing, Quality, Engineering, and Supply Chain.
• Document activities clearly and accurately in accordance with GDP standards.
• Present data and findings to internal teams with guidance from senior MSAT staff.
• Perform other duties as assigned.

Qualifications

Qualifications/ Skills Required:

• BS or MS in Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related field
• 0–3 years of experience in biopharma, MSAT, process development, or manufacturing support

Knowledge

• Basic understanding of cGMP manufacturing environments
• Exposure to bioconjugation processes such as ADCs or AOCs is preferred but not required
• Familiarity with purification techniques such as TFF and chromatography (Protein A, IEX, HIC) is a plus
• Understanding of aseptic techniques and single-use systems is a plus
• Strong attention to detail and documentation practices
• Ability to follow technical instructions and learn quickly in a fast-paced environment
• Basic data analysis skills using Excel or similar tools
• Strong communication skills and ability to work in cross-functional teams

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.

Physical Requirements

• Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time.
• Occasionally lift and or move objects up to 30 pounds.
• Stand/walk during entire length of shift.
• Use arms, hands and fingers to handle, feel or reach.
• Ability to climb, balance, stoop, kneel, crouch, or crawl.
• Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.
• Ability to gown into ISO 7/8 suites and adhere to gowning policies and procedures.

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.