Vice President Head of CMC, Science and Technology
Vice President Head of CMC, Science and Technology
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
As a Vice President for Global CMC Science and Technology you will lead and manage the Global CMC Science and Technology Department within Global Technical Operations at Sobi. CMC Science and Technology is responsible for for overseeing all aspects of CMC development commercial product technical lifecycle management including process and analytical development device and packaging development Scale up and Tech Transfers process and analytical technical expertise to support external manufacturing quality operations research and development and due diligence.
You will lead a talented team of scientists and engineers driving the development implementation and technical and scientific management of robust and scalable manufacturing processes for our pipeline of pharmaceutical products across a wide range of technologies from small molecules to advanced Biological products. Sobis products are manufactured within our external network of partners and contract manufacturers and analytical labs. You will also be responsible for an in-house analytical development lab in Stockholm.
You will work across all levels - strategic tactical and operational - making a tangible impact on Sobis mission and long-term success. If you are ready to take ownership lead with vision and drive strategic change we want to hear from you.
This position is based at our Global Headquarters in Stockholm Sweden or Global hub in Basel Switzerland reporting directly to Senior Vice President Head of Global Technical Operations.
Key Responsibilities
- Lead and mentor a high performing team of scientists and engineers fostering a culture of innovation collaboration and continuous improvement in accordance with the mission visions strategic goals and values. Secure talent development and retention and an open transparent and inspiring environment for the team.
- Develop and implement CMC strategies to support the advancement of our product pipeline from late-stage development through commercialization and the full life cycle of our products.
- Accountable for CMC development and ensure on-time and on-budget delivery of late stage development assets through all phases from development activities to regulatory file review and approval.
- Accountable for continuous process device & packaging and analytical method improvements in order to maintain compliance improve supply robustness increase cost effectiveness and secure sustainable supply of product to our patients world-wide.
- Accountable for timely and cost-effective scale up and technology transfer to support product launches geographic expansion and manufacturing/testing site change that meets all relevant regulatory requirements and quality stanards.
- Ensure commercial product device process and analytical method ownership to maintain technical knowledge along the life cycle and support external manufacturing and quality with technical changes deviations investigations health authorities inspections and compliance reports.
- Providing CMC expertise and support to relevant CMC regulatory file sections to support regulatory filling of new product introduction and regulatory variation of registered product and analytical methods.
- Support due diligence for business development projects assessing CMC packages timelines costs risks and opportunities.
- Establishing and maintaining quality procedures within area of responsibility and ensure implementation in accordance with applicable laws regulations and guidelines in compliance with Sobi global procedures and processes.
- Act as a key member of the Global Technical Operations Leadership Team ensuring seamless cross-functional collaboration with cross-functional teams including R&D External Manufacturing Supply Chain Quality Regulatory Affairs and Clinical Development.
- Manage budgets and resources effectively to achieve project milestones and deliverables.
Qualifications :
- Ph.D. in Chemistry Biochemistry Chemical Engineering or a related field.
- Minimum 10 years of experience in the pharmaceutical/biotech industry
- Proven strategic leadership experience with the ability to inspire and motivate a diverse and global team extensive experience from working in an international organization and across borders.
- Extensive and in-depth knowledge about clinical & commercial manufacturing CMC process and analytical development CMC technical lifecycle management.
- In depth understanding of regulatory and quality requirements in relevant area
- Experience of operating CMC Science and technology activities in an outsourced environment and working closely with CMO CDMO CLO understanding of outsourced pharmaceutical manufacturing business drivers.
- Exceptional problem-solving and decision-making abilities.
- Strong communication and interpersonal skills with the ability to collaborate effectively with cross-functional teams.
- Analytical mindset with the ability to translate data into actionable insights and strategic recommendations.
- Excellent verbal and written communication skills in English
Here at Sobi we live by our core values: Care Ambition Urgency Ownership and Partnership!
Additional Information :
How to apply
We have an ongoing selection process in this recruitment and ask you to send your application as soon as possible. Click apply and include your resume in English.
Why Join Us
Here at Sobi our mission and culture get us excited to come to work every day but here are a few more reasons to join our team:
- Emphasis on work/life balance
- Collaborative and team-oriented environment
- Opportunities for professional growth
- Diversity and Inclusion
- Competitive compensation for your work
- Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments
Sobi is a global company with over 1900 employees in more than 30 countries and are committed to the societies where we operate. We are a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating diseases providing reliable access to innovative medicines in the areas of haematology immunology and specialty care. Sobis share is listed on Nasdaq Stockholm. More about Sobi at and LinkedIn.
We know our employees are our most valuable asset and our culture conveys that. We offer a competitive benefits package to support the health and happiness of our staff.
Sobi Culture
At Sobi we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases and have used this knowledge to shape our business to find new ways of helping them.
As a specialized biopharmaceutical company we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments we help make medicine more accessible and open more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one but we know we cant change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients partners and stakeholders across the entire value chain. Together we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.
Remote Work :
Yes
Employment Type :
Full-time
Employment Type
Remote
