T2509 - Analytical Development & Quality Control Scientist (Maternity Cover)
Vor 2 Tagen
**_At Debiopharm, every step we take is guided by one purpose: improving the lives of people affected by cancer and infectious diseases. As a privately-owned Swiss biopharmaceutical company, we’re driven by science, but above all, by the people behind every treatment — the patients and their families._**
**_ Through our unique “development only” model, we bring forward promising therapies and transform them into treatments that can reach those who need them most, faster._**
- Are you a passionate analytical development expert with a strong technical background in pharmaceutical R&D? Join our dynamic team for a maternity cover role where your expertise will directly impact the development of cutting-edge investigational medicinal products (IMPs)._
**Analytical Development & Quality Control Scientist (Maternity Cover - Temporary 6 months)**
Reporting to the Head of Analytical Development & Quality Control (AD&QC), you will lead analytical development activities for both Drug Substances (DS) and Drug Products (DP), produced by our selected CDMOs. You will define and implement control strategies to ensure efficiency, quality, and regulatory compliance throughout all development stages.
**Your Mission.**
- Lead the development and implementation of control strategies for DS and DP, including method development/validation, specification setting, and impurity characterization.
- Define and manage stability study strategies (development and ICH), and determine product shelf-life.
- Act as the key contact for CDMOs/CROs: oversee activities, challenge proposals, ensure scientific/documentary compliance.
- Collaborate in CMC strategy development, contributing to robust and agile project plans.
- Support formulation and process development with high-throughput analytical tools.
- Participate in CDMO/CRO selection processes, reviewing analytical capabilities and proposals.
- Conduct studies to better understand molecules and support process development and out-licensing goals.
- Promote continuous improvement within the AD&QC and Pharmaceutical Development teams.
- More than a checklist of skills, we’re looking for someone who shares our commitment to science with purpose._
**Requirements**:
- Master’s degree or PhD in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
- 5-7 years of hands-on experience in analytical development within pharmaceutical manufacturing organizations.
- In-depth expertise in analytical techniques such as LC, GC, MS, spectroscopy; strong knowledge of GMP and regulatory guidelines (ICH, FDA, Pharmacopeias).
- Experience with peptide characterization and synthetic API chemistry.
- Familiarity with analytical techniques for solid oral and parenteral dosage forms.
- Experience in preparing early and/or late-stage regulatory documentation.
- Proven ability to drive innovation and scientific advancement.
- Ability to manage external partners and work cross-functionally in a matrix environment
- Excellent communication skills in English (oral and written)
**Benefits**
- Being part of a company where innovation, collaboration, and impact aren’t just values — they’re how we work every day
- Partner with teams across disciplines, at the forefront of oncology and anti-infective development
- An inclusive and respectful workplace — proud to be Equal-Pay certified
- Grow in a culture that values people, purpose, and performance
- A chance to grow, share, and shape the future of healthcare
**What to Expect in the Recruitment Process**:
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Lausanne, Schweiz Debiopharm Vollzeit**_At Debiopharm, every step we take is guided by one purpose: improving the lives of people affected by cancer and infectious diseases. As a privately-owned Swiss biopharmaceutical company, we’re driven by science, but above all, by the people behind every treatment — the patients and their families._** **_ Through our unique “development only”...
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Lausanne, Schweiz Debiopharm VollzeitDescription **At Debiopharm, every step we take is guided by one purpose**: improving the lives of people affected by cancer and infectious diseases. As a privately-owned Swiss biopharmaceutical company, we’re driven by science, but above all, by the people behind every treatment — the patients and their families. Through our unique “development...
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