CMC Analytical Development and Drug Product Senior Scientist
vor 4 Wochen
Debiopharm is a biopharmaceutical company dedicated to improving patient outcomes and quality of life through innovative therapies targeting high unmet medical needs. Our company focuses on drug development, manufacturing, and digital health investment. We aim to bridge the gap between disruptive discovery products and patient access in international markets by identifying high-potential compounds, demonstrating their safety and efficacy, and partnering with large pharmaceutical companies to maximize global patient access.
At Debiopharm, you will be part of a team fighting against cancer and infectious diseases, working on new innovative medicines for patients. Efficiency and saving lives are our core values.
We are seeking a CMC Analytical Development and Drug Product Senior Scientist - Contractor for our Pharma Development – R&D organization based at our Headquarters in Lausanne.
Mission:
As a CMC Analytical Development and Drug Product Senior Scientist - Contractor, you will contribute to the Pharmaceutical Development department and teams to ensure the analytical and drug product development, manufacturing, and controls tailored to the needs of patients, while guaranteeing a supportive quality documentation and an industrialization process in conformity with the development status of the projects.
Your responsibilities will be:
- Establish and implement analytical and drug product development and validation strategies (including Life Cycle Management);
- Define specifications and justification thereof for drug product, lead the analytical method development programs, define the stability study strategies (development and ICH studies) and evaluate the data in order to determine a shelf life, lead the evaluation and characterization of impurities;
- Lead formulation development programs as well as the production and release of several drug products for late stage clinical trials in coordination with the CMC and wider project teams in line with patients' needs;
- Lead regulatory and control strategies for drug products in line with Quality by Design principles, taking into consideration the status of the project, assessing risks, and ensuring their mitigation;
- Develop and maintain suppliers' platform and experts, while selecting the optimal suppliers for drug product development, manufacturing, and controls, negotiating offers and contracts with the support of the Outsourcing Manager, and ensuring an efficient business continuity management;
- Act as the main point of contact, manage, challenge, lead analytical and drug product activities performed at CDMO's/CRO's, and assure the conformity (scientific and documentary) with external partners;
- Preparation, review, archiving of analytical and drug product CMC source documents for clinical trial application (Quality section), acting as a support to CMC Regulatory Affairs.
Requirements:
Your profile:
- Master degree or Ph. D. in pharmaceutical sciences, or equivalent by experience;
- At least 5 years' experience in the pharmaceutical industry working in hands-on analytical and drug product development roles on late stage development;
- A proven track record in the development of liquid and solid parenteral dosage forms at an industrial level, and/or oral dosage form;
- Extensive expertise in pharmaceutical quality control of drug product/drug substance (small molecule, peptide), physico-chemical tests (such as chromatographic methods), microbiological tests;
- Solid knowledge of regulatory framework for pharmaceutical drug development and quality guidelines (GMP, Pharmacopeias, ICH, EMA/FDA guidances...) applicable to investigational medicinal products;
- Experience in outsourcing and managing a network of suppliers is a plus;
- Scientific curiosity, detail-oriented and capable of identifying and solving complex scientific problems;
- Strong team spirit and ability to collaborate in a matrix organization;
- Fluent in English and ideally a good knowledge in French.
Benefits:
Debiopharm offers employees:
- International, highly dynamic environment with a long-term vision;
- Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry;
- Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry;
- Participation in a company where innovation, people, and entrepreneurship are the fundamental keys to success;
- Proud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunities.
-
Senior Scientist
vor 4 Wochen
Lausanne, Waadt, Schweiz Debiopharm VollzeitDebiopharm is a leading biopharmaceutical company based in Switzerland that is dedicated to improving patient outcomes and quality of life through innovative research in oncology and infectious diseases. Our main activities include drug development, drug manufacturing, and digital health investment. Debiopharm International SA aims to develop therapies that...
-
Lausanne, Waadt, Schweiz Debiopharm VollzeitAbout DebiopharmDebiopharm International SA is a privately-owned Swiss biopharmaceutical company dedicated to the development of innovative therapies for oncology and infectious diseases. Our commitment is to improve patient outcomes and quality of life through cutting-edge research and development.Job DescriptionWe are seeking a highly skilled Senior...
-
Pharmaceutical Development Senior Scientist
vor 5 Stunden
Lausanne, Waadt, Schweiz Debiopharm VollzeitAbout DebiopharmDebiopharm is an innovative biopharmaceutical company dedicated to improving patient outcomes and quality of life through research in oncology and infectious diseases.We develop innovative therapies that address high unmet medical needs. Our unique business model enables us to act as a bridge between disruptive discovery products and patient...
-
Drug Development Expert
vor 2 Wochen
Lausanne, Waadt, Schweiz Debiopharm VollzeitAbout DebiopharmDebiopharm is an independent biopharmaceutical company based in Switzerland with a strong commitment to research in oncology and infectious diseases. Our main activities include drug development, manufacturing, and digital health investment.We aim to develop innovative therapies that target high unmet medical needs. Our unique business model...
-
Lausanne, Waadt, Schweiz Debiopharm VollzeitAbout Debiopharm: A privately-owned Swiss biopharmaceutical company committed to research in oncology and infectious diseases to improve patient outcomes and quality of life.Job Description: We are seeking a Senior Scientist for our Pharmaceutical Development organization based at our Headquarters in Lausanne.Key Responsibilities:Develop and lead analytical...
-
Pharmaceutical Development Specialist
vor 2 Wochen
Lausanne, Waadt, Schweiz Debiopharm VollzeitAbout DebiopharmDebiopharm International SA is an independent biopharmaceutical company with a strong commitment to research in oncology and infectious diseases. Our primary objective is to improve patient outcomes and quality of life. We focus on drug development, manufacturing, and digital health investment. Our unique "development only" business model...
-
Data Scientist with Analytical Skills
vor 3 Wochen
Lausanne, Waadt, Schweiz Flexsis Morges VollzeitJob Description:As a Data Scientist with analytical skills, you will be responsible for analyzing and interpreting complex data to inform business decisions. Your analytical skills will enable you to identify trends and patterns in data, and develop data-driven solutions to business problems. You will work closely with cross-functional teams to implement...
-
Senior Product Development Manager
vor 5 Stunden
Lausanne, Waadt, Schweiz Technis VollzeitAbout TechnisAt Technis, we revolutionize decision-making processes by harnessing the power of real-world data to simplify physical space management. Our innovative products for connected spaces transform ideas into reality.We believe our Product Managers are the heartbeat of these efforts, shaping the future of our solutions by understanding users' needs...
-
Senior 3D Product Development Specialist
Vor 4 Tagen
Lausanne, Waadt, Schweiz Capgemini VollzeitAbout Capgemini Engineering SwitzerlandWe value excellence, diligence, responsibility, dynamism and innovation. Our diverse workplace offers opportunities for professional and personal growth.Job Title: Senior 3D Product Development SpecialistEstimated Salary Range: CHF 80,000 - CHF 120,000 per yearJob DescriptionUnderstand customer business requirements and...
-
Global Program Manager
vor 1 Woche
Lausanne, Waadt, Schweiz Debiopharm VollzeitAbout DebiopharmDebiopharm International SA is an independent biopharmaceutical company based in Switzerland with a long-standing commitment to research in oncology and infectious diseases. Our primary focus is on developing innovative therapies that address high unmet medical needs. We employ a unique 'development only' business model, serving as a bridge...
-
Data Scientist
vor 3 Wochen
Lausanne, Waadt, Schweiz ARDAM SA VollzeitAt "{company}", we're seeking a talented Data Scientist to join our team. In this role, you'll work closely with our data analysis team to develop and implement statistical models that drive business growth and inform strategic decisions.Your responsibilities will include:Collecting and analyzing large datasets to identify trends and insightsDeveloping and...
-
Lausanne, Waadt, Schweiz Debiopharm VollzeitAbout DebiopharmDebiopharm International SA is a privately-owned Swiss biopharmaceutical company dedicated to research in oncology and infectious diseases. Our mission is to develop innovative therapies via our unique "development only" business model, acting as a bridge between disruptive discovery products and patient access in international markets.
-
Research Scientist
vor 1 Monat
Lausanne, Waadt, Schweiz Université de Lausanne VollzeitAramco Services CompanyResearch Scientist - Drilling TechnologyResearch and Development - Houston, TX - Full TimeJob SummaryThe incumbent will provide materials synthesis, chemical interactions, characterization, and oilfield chemical application testing to support the advanced oilfield chemical products development at the Aramco Research...
-
Senior Product Manager
vor 2 Wochen
Lausanne, Waadt, Schweiz Nexthink VollzeitAbout the Role:Nexthink is seeking a Senior Product Manager to lead the development of our cutting-edge product, leveraging data and AI to empower our customers' IT teams. As a DEX pioneer, you will be responsible for building and managing a key new product that shapes the future of the global IT market category.Key Responsibilities:Research the market and...
-
Research Scientist
vor 4 Stunden
Lausanne, Waadt, Schweiz Université de Lausanne VollzeitCompany Overview\Aramco Services Company is a leading provider of research and development services in the energy sector.\Salary\The estimated annual salary for this position is $85,000-$110,000 based on industry standards and location.\Job Description\We are seeking an experienced Research Scientist to join our team at the Aramco Research Center―Houston....
-
Digital Experience Product Strategist
Vor 6 Tagen
Lausanne, Waadt, Schweiz Nexthink VollzeitUnlock New Opportunities in Digital Employee ExperienceNexthink is a pioneering leader in digital employee experience management software, empowering IT leaders with unparalleled insight to optimize employee experiences worldwide.Job Summary:We seek a seasoned Senior Product Manager to spearhead the development of a cutting-edge new product that harnesses...
-
Innovative Product Development Specialist
Vor 2 Tagen
Lausanne, Waadt, Schweiz Michael Page Switzerland VollzeitAt Michael Page Switzerland, we are seeking an Innovative Product Development Specialist to join our client's Technical team.You will be responsible for designing, developing, and optimising high-end medical devices products. This role involves supporting the industrialisation process and working closely with external partners to bring innovative solutions...
-
Senior Research and Development Clinical Associate
vor 4 Wochen
Lausanne, Waadt, Schweiz Pharmiweb VollzeitThe Senior Research and Development Clinical Associate will oversee daily operations at investigational sites across Europe for our groundbreaking structural heart valve pivotal trial. This includes ensuring compliance with international guidelines, local regulations, and company policies.About the PositionThis is a pivotal role in managing a global trial,...
-
Senior Software Engineer
vor 3 Wochen
Lausanne, Waadt, Schweiz Data Consulting SA VollzeitAbout the Role:We are seeking a highly skilled Senior Software Engineer to join our team. As a Senior Software Engineer, you will be responsible for designing, developing, and maintaining our company's backend systems.Responsibilities:Design and develop scalable, efficient, and well-documented backend systemsCollaborate with cross-functional teams to...
-
P&A Product Development Manager for EMEA
vor 4 Stunden
Lausanne, Waadt, Schweiz BRP VollzeitJob DescriptionWe are seeking a P&A Product Development Manager to lead our team in the EMEA region.Key Responsibilities:Manage and develop our accessory portfolio for on-road, off-road, and on-water Powersports vehicles.Collaborate with global product teams to ensure EMEA product needs and regulations are met.Coordinate with Service and Operations teams to...
