Job Description

We are looking for...

....a highly motivated

Pharmaceutical Development & Manufacturing Manager

for our

Technical Operations

department.

Your tasks

Responsible for the pharmaceutical development and manufacturing of drug products for clinical and commercial supplies in compliance with GMP and regulatory requirements Oversee, manage and drive the outsourced pharmaceutical activities with CMO and/or partner during development and commercialization phase Select appropriate formulations and formulation technologies based on target product profile and biopharmaceutical properties Proactively track project progress and critical path activities; continuously review project risks and issues, and develop and execute issue resolution and/or mitigation plan(s) Act as CMC or Product Operations team member and collaborate with multifunctional teams within Basilea and externally with partners Prepare, review and approve the relevant registration documentation Contribute to supplier selection & contracting as well as ordering and payment processes Ensure acquisition of know-how and maintaining profound expertise especially in dosage form manufacturing technologies, technology and regulatory guidelines Proactively track project progress and critical path activities; continuously review project risks and issues and execute issue resolution and/or mitigation plan(s) Author, review and contribute to protocols and reports for development, scale up or process validation in view of requirements for registration and evaluate data provided by CMOs Perform batch record review and pharmaceutical activities and collaborate on a Batch Release Team to ensure commercial batch release Organize technical visits and support audits of external pharmaceutical manufacturers

Your profile

PhD degree in Pharmaceutics or equivalent 5+ years of relevant experience in pharmaceutical industry with experience in solid dosage manufacturing Experience in managing international development and manufacturing CMOs GMP knowledge in solid dosage development is a must Experience in outsourcing in a virtual drug development environment, regulatory documentation and CMC project management including Preformulation/Analytics is an advantage Experience with digital and AI tools, combined with a strong focus on process optimization and a passion for innovative ideas Strong organizational and communication skills, fluent in English, written and spoken, any other language is a benefit Proactive personality, which drives projects towards distinctive goals, as well as being able to work independently and collaboratively in a team environment Willingness to travel abroad from time to time

Why us?

Basilea is committed to putting people first. In addition to competitive remuneration, we offer the opportunity to work on inspiring, cross-functional projects in an engaging working environment. We strongly believe that every employee can make an impact and is vital to our success.

If you wish to become part of a company that strives to make a difference to the lives of patients worldwide, we are looking forward to receiving your application.

Additional information can be found on our website www.basilea.com.
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About us

Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. Basilea has about 150 employees. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial or fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN).