MSAT Scientist I - Permanent - Bristol, PA
Drive the science behind next‑generation bioconjugates-where precision meets transformative medicine.
Proclinical is seeking an MSAT Scientist I - Bioconjugation to support the transfer, execution, and ongoing optimization of bioconjugation processes, including ADCs and AOCs, within a cGMP manufacturing environment.
Primary Responsibilities:
The successful candidate will emphasize technical execution, documentation, and hands-on manufacturing support, working collaboratively with cross-functional teams to ensure process accuracy, compliance, and continuous improvement.
Skills & Requirements:
- Degree in Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related field.
- Basic understanding of cGMP manufacturing environments.
- Exposure to bioconjugation processes such as ADCs or AOCs preferred but not required.
- Familiarity with purification techniques like TFF and chromatography (Protein A, IEX, HIC) is a plus.
- Understanding of aseptic techniques and single-use systems is advantageous.
- Strong attention to detail and documentation practices.
- Ability to follow technical instructions and adapt quickly in a fast-paced environment.
- Basic data analysis skills using Excel or similar tools.
- Effective communication skills and ability to work in cross-functional teams.
- Preferred experience with high-potency APIs, process validation, PPQ, and commercial tech transfer.
- Familiarity with regulatory expectations for complex biologics and bioconjugates is a plus.
Physical Requirements:
- Ability to stand, sit, and walk for extended periods.
- Occasionally lift and move objects up to 30 pounds.
- Perform physical activities such as climbing, stooping, kneeling, and crouching.
- Visual abilities including near and far sight, color vision, and focus.
- Ability to gown into ISO 7-8 suites and adhere to gowning policies.
The MSAT Scientist I's responsibilities will be:
- Adhere to 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.
- Contribute to deviation investigations, root cause analysis, and CAPA implementation with guidance from senior staff.
- Collect, trend, and analyze data 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 developing training materials and updating process documentation.
- Collaborate with Manufacturing, Quality, Engineering, and Supply Chain teams.
- 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.
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at m.raletz@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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