Pharmaceutical Development

vor 4 Wochen

Allschwil, Schweiz Basilea Pharmaceutica International Vollzeit

**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 cGMP and regulatory requirements
- Oversee, manage and drive the outsourced pharmaceutical development studies, transfer and manufacturing activities, in line with the overall project plan, interact productively with the C(D)MO
- Provide technical oversight for commercial pharmaceutical production and ensure timely batch release
- Proactively track project progress and critical path activities; continuously review project risks and issues and execute issue resolution and/or mitigation plan(s)
- Identify, evaluate and select appropriate pharmaceutical development and manufacturing organizations, and contribute in the execution of contracts and technical agreements
- Select appropriate formulations and formulation technologies based on target product profile and biopharmaceutical properties
- Review protocols for development, scale up manufacture, process validation in view of requirements for registration
- Compile, review and contribute to reports and evaluate data provided by the CDMO
- Prepare review and approve the relevant registration documentation and support requests from Health Authorities
- Interact in a project team and collaborate with multifunctional teams within Basilea and externally with partners, lead a sub team
- Lead a CMC team for assigned project(s), be responsible to establish and manage CMC project plan and budget, and coordinate project related activities

**Your profile**:

- Education in Pharmacy or equivalent, PhD degree and Project Management experience desirable
- Minimum of 5 years of relevant experience in pharmaceutical industry, experienced with aseptic manufacturing and lyophilization
- GMP knowledge in aseptic processing is a must
- Experience in outsourcing in a virtual drug development environment, regulatory documentation and CMC project management including Preformulation/Analytics is an advantage
- Strong organizational and communication skills, fluent in English, written and spoken, any other language is a benefit
- Excellent IT-user skills in MS-Office, MS Project and Visio is an asset
- Proactive, interested in taking leadership and drive projects towards distinctive goals, as well as able to work independently and collaboratively in a team environment
- Exceptional learning ability, good relationship-building skills and able to work in a dynamic environment
- Willingness to travel abroad from time to time

**About us**:
Basilea is a revenue-generating, commercial-stage Swiss biopharmaceutical company. Our activities are focused in the areas of hospital antibiotics and hospital antifungals. Our portfolio comprises of two marketed anti-infective brands (Cresemba® and Zevtera®) and several preclinical anti-infective assets. We are building on our potential for sustainable growth and valuation generation, based on increasing revenues and selective investments into internal and external innovation. Basilea was founded in 2000 and is located in the life sciences hub of the Basel area. Basilea has about 150 employees. Since 2004, Basilea is listed on the SIX Swiss Stock Exchange with the ticker symbol BSLN.

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