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Analytical development and quality control manager

Basel
Actalent
EUR 30’000 - EUR 80’000 pro Jahr
Inserat online seit: 13 Juni
Beschreibung

Analytical Development and Quality Control Manager


Analytical Development and Quality Control Manager

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Life Science Recruiter, specialised in Scientific

Our client based in Basel (Switzerland) is looking for a Manager Analytical Development and Quality Control with expertise in Vaccines, Large Molecules or Antibody Drug Conjugates.

Responsibilities:

* Develops and implements analytical methods.
* Represents AD/QC in technical and CMC team meetings.
* Conducts release, retest, stability studies, and validation analyses.
* Reviews and interprets analytical data, drafts protocols, and establishes specifications.
* Designs and executes projects, reviews scientific work, and collaborates with 3rd parties.
* Evaluates and develops novel analytical techniques independently
* Manages workload for timeline and budget adherence.
* Establishes source documents for regulatory submissions, interacts with Health Authorities.
* Leads lab work for troubleshooting, investigations, deviations, and product quality.
* Responsible for analytical expertise in drug substances and/or products.
* Manages outsourcing of analytical activities to CROs/CMOs.
* Participates in technology transfer and contributes to lab advancements.

Requirements:

* Expertise in vaccines, large molecules, or antibody-drug conjugates is a must
* In addition to knowledge of the GMP/regulatory requirements, a strong background in analytical chemistry is required
* Broad knowledge in analytical chemistry. Basic knowledge in synthetic chemistry, drug substance processing and/or formulation development, pharmaceutical processing with a deep understanding of pharmaceutical sciences related to drug substance or product development
* Experience in the development and performance of analytical tests for a variety of drug substances and products

Duration: 12 months contract

If you feel confident about this opportunity, we encourage you to apply, or to reach out to me via email at cpflieger@actalentservices.com.


Seniority level

* Seniority level

Mid-Senior level


Employment type

* Employment type

Contract


Job function

* Job function

Science, Analyst, and Management
* Industries

Pharmaceutical Manufacturing and Biotechnology Research

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