Develop and implement strategies for drug product development, in alignment with the organization's goals and objectives
Select, contract and supervise development and commercial manufacturing activities at CMOs in accordance with cGMP
Manage and mentor a team of Pharmaceutical Development Managers, fostering a collaborative and innovative environment
Drive the digital/AI transformation of future drug product development
Oversee multiple drug development projects (clinical and life-cycle management), ensuring timely and efficient progress towards milestones
Ensure that all pharmaceutical development activities comply with relevant regulations and guidelines (e.g., FDA, EMA)
Plan and manage the pharmaceutics budget, allocating resources effectively to support development projects and commercial product related activities
Work closely with the Technical Operations team, other departments, such as clinical development, regulatory affairs, as well as license partners, to ensure seamless drug development and commercialization
Identify and evaluate new technologies and approaches in pharmaceutics to improve drug product development. Ensure access to and storage of relevant process data
Your profile
PhD degree in Pharmaceutical Science or equivalent
Minimum 10 years of experience in pharmaceutical formulation development, process engineering and validation
In-depth knowledge of pharmaceutical development and dosage form manufacturing for both parenteral and solid oral dosage forms. Hands-on experience in formulation & manufacturing process development would be beneficial
Experience with regulatory requirements and quality systems related to pharmaceutical development and manufacturing, including cGMP, FDA, and ICH guidelines and associated regulatory filings such as NDA/MAA, IND/IMPDs
Demonstrated experience with digitalization and digital tools would be an asset
Strong leadership, management, and problem-solving skills
Well organized and self-motivated, with excellent communication and presentation skills
Fluent in English, written and spoken, any other language is a benefit
Ability to travel up to 20% of 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 via our careers portal.
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).
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