Technical Project Leader/CMC Leader

Vor 3 Tagen

Basel, Basel-Stadt, Schweiz Actalent Vollzeit CHF 80'000 - CHF 160'000 pro Jahr

For one of our clients based in Basel, we are urgently looking for a
Technical Project Leader/CMC Leader
. You will lead the technical development of several
oral solid dosage forms / vaccine projects,
from early phase development activities up to commercialization, including technical transfer and clinical trial material supply with external partners.

Job Responsibilities

  • Act as Technical Project Leader for Drug Product development activities (in-house or external): plan, organize and administer the different aspects of the technical activities required for development, scale-up, validation and manufacturing of a drug from development up to commercial supplies;
  • Oversee the CMC component of drug development from early phases through post-market surveillance, ensuring compliance with FDA and EMA regulations to the least;
  • Support the development, communication and execution of the overall CMC strategy, by managing and coordinating multi-functional teams (drug substance technical project leader, internal technical development, quality assurance, technical regulatory affairs, analytical development and control, external manufacturing and packaging);
  • Lead the collaboration with external development partners with special emphasis on cost efficiency, timelines and scientific quality;
  • Ensure sufficient and timely supplies for development projects based on input from the Global Supply Chain, CMC, Project and/or Life Cycle management functions;
  • Ensure compliance with regulatory guidelines.

Candidate's Requirements

  • Pharmacist or Equivalent with PhD Minimum of 10 years job relevant working experience in the pharmaceutical industry
  • Minimum of 5 years of leading of an interdisciplinary drug product / CMC team
  • Strong scientific expertise in small molecule formulation development for oral solid dosage forms, as well as in large molecule formulation development, especially vaccines and glycoconjugate vaccines
  • Profound knowledge of GMP, quality control and pharmaceutical development and/or production processes, based on current guidelines
  • Profound knowledge in QbD, DOE and QRM
  • Fluent in English and at least basic knowledge of an additional European language. Ability to communicate in German or French is an advantage

Location: Basel

Start date: ASAP

Length: until June 2026

Hybrid position

If you are interested please apply directly, or send me your CV

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