Analytical Project Leader (APL), 100% (m/w/d) — CordenPharma

Role overview

CordenPharma is one of the leading Contract Development and Manufacturing Organizations (CDMO) and develops and produces pharmaceutical active ingredients, drugs and related packaging services on behalf of its customers as a “full-service” service provider. The group employs around 3,500 people. Our network in Europe, Asia and the USA offers flexible and specialized solutions for six technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules and Oligonucleotides. We strive for excellence in supporting this network and are committed to providing the highest quality products for the benefit of patients. Our People Vision: We strive for excellence. We share our passion. Together, we make a difference in patients’ lives. Analytical Project Leader (APL), 100% (m/f/d)

• Liestal
• By agreement
• Full time
• Perpetual

Your exciting task area

• They are the central contact person (SPOC) for all analytical work packages in development and production projects for the production of APIs and excipients and ensure their timely, quality and budget-oriented implementation for our customers.
• They are responsible for and lead all analytical activities, such as method development, validation and troubleshooting, across all project phases (early to late stage). You will contribute your expertise at the API site in Liestal, especially in the areas of peptides, lipids and small molecules.
• They plan, coordinate and prioritize the analytical work packages in close cooperation with internal and external stakeholders.
• They track project progress, report regularly to stakeholders and initiate appropriate measures for complex analytical questions.
• You will assume technical responsibility for the analytical project team, e.g. analytical experts and analytical scientists, in a matrix organization.
• Responsibility for the analytical contribution in the context of project evaluations.
• Preparation, revision and review of GMP-relevant project documents (plans, reports, methods).
• You create and test SOPs in your area of responsibility and ensure their up-to-date nature and regulatory compliance.
• They ensure that analytical SOPs and processes always comply with current regulatory requirements.
• They drive the further development of analytical processes, documentation and tools and support the establishment of modern methodological and procedural standards in the field of analytics.
• They coach APL colleagues, support the recruitment and training of new employees and promote the further development of analytical skills in the team.

Your profile

• Completed studies in analytical chemistry, pharmacy or a comparable natural science field
• Several years of experience in analytical project management over several development phases (early to late stage), ideally with customer contact
• In-depth knowledge in instrumental analysis (e.g. HPLC, GC, MS) as well as experience with peptides, lipids, small molecules are advantageous
• Safe handling of cGMP and regulatory requirements
• Very good communication skills and security in dealing with complex analytical questions
• Independent, structured and customer-oriented working methods as well as high reliability and teamwork
• Very good German and good English skills in word and writing.

An attractive workplace with a high level of responsibility Corden Pharma offers you interesting and versatile tasks in a highly motivated team. Through a practice-oriented training, we help you quickly gain professional security in order to work independently with a high level of personal responsibility.

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