HHJ BAU GmbH seeks a Senior Analytical Project Leader in Basel for a freelance onsite role. The position focuses on developing control strategies for drug substances and products while coordinating analytical activities and mentoring junior staff.
This position acts as the central hub for project information, guiding technicians and junior scientists through their work. The role is responsible for planning and documenting experiments, preparing regulatory submissions, and ensuring analytical activities meet quality standards across departments.
Responsibilities
- Create phase-appropriate control strategies for both drug substances and finished products.
- Serve as the main contact for project updates and provide coaching to technicians and junior scientists.
- Coordinate all analytical tasks, including method development, validation, data generation, and quality documentation.
- Supervise internal lab operations and oversee testing performed by external contract laboratories or CDMOs.
- Plan and document experiments independently, ensuring readiness for regulatory filings like IND and NDA.
- Ensure all work adheres to cGMP, safety protocols, and regulatory standards.
- Collaborate with cross-functional stakeholders to align project goals.
Requirements
- Master’s degree or Ph.D. in chemistry, pharmacy, or a related discipline, plus a minimum of three years in analytical development for small molecule drug substances or products.
- Strong expertise in HPLC and UPLC techniques.
- Demonstrated experience in developing and validating analytical methods that comply with ICH guidelines.
- Solid background in degradation and stability studies for small molecules, including forced degradation and impurity profiling.
- Clear understanding of specifications for drug substances and products.
- Excellent English communication skills.
- High attention to detail and a strong quality mindset.
- Comfort with digital tools to support transformation efforts.
- Ability to work effectively in fast-paced environments and collaborate respectfully with teams, customers, and stakeholders, even under pressure.
Nice to have
- Proficiency in German.
- Experience with statistical analysis of analytical data.
About the company
HHJ BAU GmbH is a highly regarded organization operating within an international environment.
- The company is very renowned and operates in an international environment.
How to apply
Documents to submit:
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