The Position
Reporting to the Senior Director Strategic Manufacturing Solutions and Pilot Plant, the Associate Director, Strategic Manufacturing Solutions (DSP)
The role provides technical leadership for the development, transfer, scale-up and GMP implementation of biologics mainly downstream processes, with responsibility for manufacturing readiness, process robustness and regulatory compliance.
This position ensures that high-standard processes are established to meet regulatory expectations and advance groundbreaking biologics, which includes mAbs as well as Complex molecules. It is also responsible for shaping processes and teams to enable seamless GMP manufacturing operations.
The role will provide technical advice and expertise to the Biological Development Center (BDC) and to GMP teams and will work with all members collaboratively in a pragmatic and solution-oriented manner
Your Responsibilities
- Review and assess current processes within the organization, identify problem areas which generate unnecessary waste, and recommend changes with the aim of increasing efficiency and effectiveness (company-wide).
- Document these new processes in line with current best practices and GMP regulations
- Lead and support technology transfer of biologics processes from the Basel Development Center and client sites into GMP manufacturing in Heidelberg, with primary technical ownership for DSP.
- Support and troubleshoot in the planning, preparation and follow-up of production campaigns including overcoming technical challenges.
- Identify gaps and recommend solutions for EMA and FDA regulatory readiness at Heidelberg GMP Site. Develop a roadmap for implementation, working together with site leadership
- Provide technical expertise and advice for Customer Proposals as needed
- Provide technical sales support for Customer Pitches and troubleshooting
- Be a role model for the rest of the organization in embracing change and the delivering against the new Vision of Celonic, and speak with “one voice”.
- Complete any other projects and tasks as requested by the CEO / Senior Management of Celonic.
Job Requirements
- PhD or Master’s degree in biochemistry, biology, pharmaceutical sciences, engineering or related field
- You have at least 5-7 years of experience in pharmaceutical industry (Biologics DS manufacturing preferred) with main focus on manufacturing operations, validation or MSAT
- Deep expertise in DSP (Downstream Processing) such as chromatography, TFF/UFDF, viral clearance, filtration, process scale-up, process characterization, validation and troubleshooting.
- Demonstrated ability to lead complex cross-functional and cross-site initiatives in a matrix organization, including influencing stakeholders without direct reporting authority.
- EU/US GMP expectations to biologics manufacturing, technology transfer, process validation and inspection readiness. FDA/EMA inspection experience is desirable.
- Expertise in Biosimilar development and process conversions
- Strong interpersonal and leadership abilities, with experience managing cross-functional teams.
- Excellent written and verbal communication skills, particularly for regulatory documentation and stakeholder presentations.
- Ability to streamline operations and establish agile processes in a dynamic environment
- Fluent in English and German (Spoken and written).
Why Celonic?
- Make a difference by directly impacting patients lives
- Biologics is an attractive, high growth sector with professional development
- Offers a multinational and diverse workplace
- Proud to be a pioneer in “Next Generation” manufacturing technologies
- Family owned: Entrepreneurial, and short communication lines
- Basel is a great place to live, play and work in the center of Europe