Biopharmaceutical Formulation Development Specialist
Vor 3 Tagen
We are a global biotech company with a strong vision for making a positive impact. We foster an open, appreciative culture with an innovative mindset.
Job DescriptionThis is a specialist position in drug product manufacturing process operations. As a Biopharmaceutical Formulation Development Specialist, you will lead biologic formulation development and support technical development for vaccine candidates and commercial products.
- You will plan and execute experiments for vaccine candidates and adjuvants, providing data interpretation and recommendations to project teams.
- You will offer technical support for vaccine filling processes in mid to late-stage development, assisting with a newly built drug product filling line and external CMO partners.
Key responsibilities include leading scientific and project planning, collaboration and stakeholder engagement, supporting manufacturing and process design, project management and risk assessment, due diligence and practical assessments, and compliance and documentation.
SalaryThe estimated annual salary for this position is approximately €60,000, based on full-time employment. Our salaries are market-oriented and aligned with qualifications and experience.
Required Skills and QualificationsTo be successful in this role, you should have a PhD in bioprocess manufacturing, biochemistry, biophysics, pharmaceutical technology, and minimum 5 years of experience in vaccine or biologic product development.
- You should be highly skilled in parenteral formulation development, lyophilization, suspension, adjuvantation, micro and nanoparticle stabilization, surface adsorption.
- You should have experience with product development, process tech-transfer, supporting regulatory submissions, handling queries from regulatory authorities.
Familiarity with analytical outcomes of bioanalytical methods such as ELISA, Western Blot, PRNT, and knowledge of cGMP DP manufacturing guidelines and CMC documentation requirements are also essential.
BenefitsWe offer a range of benefits, including:
- Work-Life Balance: flexitime & compensation days
- Financial Perks: Performance-related bonus & Lunch vouchers
- Lifelong Learning: Unlimited access to LinkedIn Learning & German/English courses for free
- Health & Wellbeing: Free access to sports and fitness activities via myClubs
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