Shire CMC Lead (m/f) in Neuchatel (Baxalta), Switzerland
Shire’s R&D pipeline is with 30+ programs one of the most promising and complex pipelines in the entire biopharmaceutical industry. Research and Development programs in 6 therapy areas encompass pharmaceutical and biopharmaceutical substances with highly diverse forms of administration. PDTS (Process Development and Technical Services) in Austria operates in a global environment collaborating with over 30 locations worldwide to develop processes and analytical methods for new substances as well as to support large-scale production for approved medication. PDTS strives to find innovative ways of successfully implementing product-related ideas for the benefit of our patients.
A new and challenging opportunity has become available at the Shire Austria plant for a CMC Lead. This person could also sit at the Shire Plant in Neuchâtel Switzerland.
This is an exciting career opportunity for a dynamic, autonomous, continuous improvement minded and change-agile professional to embrace a team-based culture and more specifically within the Global CMC PDTS teams in a world-class Biotech manufacturing environment.
As a key member of the Global Biologics Product Stewardship team within PDTS, the CMC Lead will be responsible for providing technical leadership to cross-functional forums and set the needed strategy to enable the execution of Chemistry, Manufacturing, and Controls (CMC) activities throughout a product's lifecycle. The Biologics Global Stewardship team is responsible for shaping the product and process strategy of Shire’s commercial biologics portfolio and supports the Biologics Operating Unit in the production, release and Life Cycle Management activities of late phase and commercial products.
Essential duties and responsibilities
Responsible to plan and execute product strategy and manage product life cycle, including process and assay development, characterization, validation, technical transfer, CMC filing documents, and support stability and shelf life for products
Define and implement plans for life cycle initiatives for products
Support the delivery and continuous supply of commercial products
Implement plans to achieve post-marketing and regulatory commitments
Support the enhancement of product and process knowledge, define and address process gaps through application of Quality by Design best practices
Co-define and execute CMC strategy to support regulatory filings for product launch and to enable market expansion
Represent Technical Operations on commercial product governance teams
Ensure delivery of CMC-related goals and facilitate communication between teams and stakeholders
Manage multiple work streams and projects, make sound and timely decisions based on project priorities
Lead Process Development and Technical Services Team (in a matrix) throughout product life cycle
Create a high functioning PDTS sub team, holding team members accountable for performance, and mentoring/coaching as needed
Ensure technical rigor of team deliverables and provides broad drug development oversight to the team
Ensure appropriate approval/endorsement of team recommendations and work streams
Drive rigorous assessment of issues and options
Drives consensus and timely decision making.
Education & Experience
BSc degree in a scientific discipline with at least 15 years or relevant experience, MSc with at least 10 years, or PhD with at least 5 years of relevant experience in large-scale biotechnology manufacturing including fermentation, cell culture, purification and finishing drug operations
Degree in Biochemistry, Protein Chemistry, Chemical Engineering or related disciplines with relevant experience in a biotechnology/pharmaceutical environment
Drug development experience
Knowledge and experience with biologics process development and GMP manufacturing support, including cell culture, protein capture and recovery, chromatographic purification, filtration, UF/DF, and drug product formulation, etc.
Proven track record of cross-functional influence
Demonstrated leadership and capability for strategic analysis and issue resolution.
Organizational skills working in a matrix environment.
Highly developed interpersonal skills is a substantial component of being successful in this demanding role.
Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following:
Be Results Oriented
Be An Excellent Manager of Self and Others
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.