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Msat Scientist I - Bioconjugation

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Proclinical

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Location:
United States , Bristol

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Category:
IT - Software Development

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

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. Drive the science behind next‑generation bioconjugates-where precision meets transformative medicine.

Job Responsibility:

  • 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

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
  • 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

Nice to have:

  • Exposure to bioconjugation processes such as ADCs or AOCs
  • Familiarity with purification techniques like TFF and chromatography (Protein A, IEX, HIC)
  • Understanding of aseptic techniques and single-use systems
  • Preferred experience with high-potency APIs, process validation, PPQ, and commercial tech transfer
  • Familiarity with regulatory expectations for complex biologics and bioconjugates

Additional Information:

Job Posted:
April 05, 2026

Employment Type:
Fulltime
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