Chemist / Conjugation Expert

Alentis Therapeutics

Allschwil

Vor Ort

CHF 120.000 - 180.000

Vollzeit

Vor 5 Tagen
Sei unter den ersten Bewerbenden

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Zusammenfassung

Alentis Therapeutics is seeking a Chemist / Conjugation Expert to lead the development, optimization, and scale-up of antibody conjugation processes through discovery, development, and clinical manufacturing. You will serve as the SME for conjugation chemistry, guiding data review, troubleshooting, and collaboration with CMC, Quality, and Regulatory teams.

You will also oversee external partnerships, define critical process parameters, support technology transfer, and contribute to regulatory

Qualifikationen

  • PhD in Chemistry, Chemical Biology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline, with a strong foundation in protein chemistry and bioconjugation.
  • At least 5 years of relevant industry experience in bioconjugation, process development, or CMC development of AxCs products including site-specific conjugation technologies, linker-payload chemistry, or other complex bioconjugate modalities.
  • Demonstrated expertise in bioconjugation chemistry and antibody-related technologies, including reaction optimization, purification, and characterization of conjugated products.
  • Hands-on experience in process development, scale-up, technology transfer, and technical support of manufacturing activities, preferably involving external partners or CDMOs.
  • Good understanding of GMP requirements and experience supporting clinical-stage development, including preparation or review of technical and CMC documentation.
  • Strong scientific communication, problem-solving, and project leadership skills, with the ability to work effectively across functions and manage technical activities with external partners.
  • Fluent in written and spoken English; additional languages are a plus.
  • A flexible, agile, and hands-on mindset, with the ability to adapt priorities and operate effectively in a fast-paced biotech environment.

Aufgaben

  • Lead the development, optimization, characterization, and scale-up of robust and reproducible antibody conjugation processes, from early development through clinical manufacturing.
  • Serve as the subject matter expert for conjugation chemistry and process development, providing scientific guidance, reviewing technical data, and leading troubleshooting and root-cause investigations for process-related issues.
  • Collaborate with the CMC Lead and the Quality manager to establish appropriate analytical control strategies and support product characterization, comparability assessments, stability studies, and investigations.
  • Define critical process parameters, process controls, and scale-up strategies, and support technology transfer, process validation readiness, and GMP manufacturing activities at external manufacturing sites.
  • Manage technical interactions with CDMOs and external development partners, including preparation and review of development plans, protocols, reports, batch documentation, technical proposals, timelines, and deliverables.
  • Contribute to CMC development strategies and author or review relevant technical documentation for regulatory submissions, responses to health authority questions, and internal governance reviews.

Kenntnisse

Bioconjugation chemistry
Process development
Leadership
Regulatory documentation
GMP knowledge
Scientific communication

Ausbildung

PhD in Chemistry/Biochemistry/Pharmaceutical Sciences

Jobbeschreibung

About this position

The Chemist / Conjugation Expert acts as SME for the development, optimization, and scale-up of bioconjugation processes for our antibody-based therapeutic portfolio. As a key technical contributor, you will define conjugation strategies, establish critical process parameters and appropriate process controls, and support product and process characterization to ensure robust, reproducible, and scalable manufacturing of the payloads and ADCs. With your technical expertise, you will supervise programs from R&D through clinical development, including technology transfer and GMP manufacturing readiness, while working closely with internal CMC, Quality, and Regulatory functions. The role includes oversight of technical activities performed by CDMOs and other external partners, troubleshooting of process-related issues, and contribution to CMC documentation and regulatory submissions.

Your tasks:

  • Lead the development, optimization, characterization, and scale-up of robust and reproducible antibody conjugation processes, from early development through clinical manufacturing.

  • Serve as the subject matter expert for conjugation chemistry and process development, providing scientific guidance, reviewing technical data, and leading troubleshooting and root-cause investigations for process-related issues.

  • Collaborate with the CMC Lead and the Quality manager to establish appropriate analytical control strategies and support product characterization, comparability assessments, stability studies, and investigations.

  • Define critical process parameters, process controls, and scale-up strategies, and support technology transfer, process validation readiness, and GMP manufacturing activities at external manufacturing sites.

  • Manage technical interactions with CDMOs and external development partners, including preparation and review of development plans, protocols, reports, batch documentation, technical proposals, timelines, and deliverables.

  • Contribute to CMC development strategies and author or review relevant technical documentation for regulatory submissions, responses to health authority questions, and internal governance reviews.

Role requirements
  • PhD in Chemistry, Chemical Biology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline, with a strong foundation in protein chemistry and bioconjugation.

  • At least 5 years of relevant industry experience in bioconjugation, process development, or CMC development of AxCs products including site-specific conjugation technologies, linker-payload chemistry, or other complex bioconjugate modalities

  • Demonstrated expertise in bioconjugation chemistry and antibody-related technologies, including reaction optimization, purification, and characterization of conjugated products.

  • Hands-on experience in process development, scale-up, technology transfer, and technical support of manufacturing activities, preferably involving external partners or CDMOs.

  • Good understanding of GMP requirements and experience supporting clinical-stage development, including preparation or review of technical and CMC documentation.

  • Strong scientific communication, problem-solving, and project leadership skills, with the ability to work effectively across functions and manage technical activities with external partners.

  • Fluent in written and spoken English; additional languages are a plus.

  • A flexible, agile, and hands-on mindset, with the ability to adapt priorities and operate effectively in a fast-paced biotech environment.

  • Work location: on site in Allschwil with up to 2 days home office.

Work permit

Candidate needs to hold a Swiss work permit or be an EU citizen eligible to work in Switzerland.

Your path forward

If you meet these requirements and are dedicated to advancing bioconjugation processes for our antibody-based therapeutic portfolio, we look forward to receiving your application. Join us in our mission to develop innovative therapies for patients in need.

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