Vice President Head of CMC, Science and Technology
Offer summary
Qualifications:
Ph.D. in Chemistry, Biochemistry, or Chemical Engineering., At least 10 years of experience in the pharmaceutical or biotech industry., Proven leadership skills with experience managing global teams., Deep knowledge of CMC process development, regulatory, and quality requirements..Key responsibilities:
- Lead and mentor the CMC Science and Technology team.
- Develop and implement strategies for product development and lifecycle management.
- Ensure timely and budget-conscious delivery of development projects and regulatory filings.
- Collaborate with cross-functional teams and external partners to support manufacturing and regulatory activities.
Job description
Company Description
Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.
Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!
At Sobi, the work we do every day redefines the standards of care and transform the lives of people living with rare diseases.
As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly and always challenging the status quo.
We are committed to an inclusive, sustainable and flexible workplace that fosters growth and development.
Job DescriptionAs 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. Sobi’s products are manufactured within our external network of partners and contract manufacturers and analytical labs. You will also be responsible for an inhouse analytical development lab in Stockholm.
You will work across all levels strategic, tactical, and operational making a tangible impact on Sobi´s mission and longterm 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 latestage development through commercialization and the full life cycle of our products.
- Accountable for CMC development and ensure ontime and onbudget 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 worldwide.
- Accountable for timely and costeffective scale up and technology transfer to support product launches, geographic expansion and manufacturingtesting 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 crossfunctional collaboration with crossfunctional 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 pharmaceuticalbiotech 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 indepth 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 problemsolving and decisionmaking abilities.
- Strong communication and interpersonal skills, with the ability to collaborate effectively with crossfunctional 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 worklife balance
- Collaborative and teamoriented environment
- Opportunities for professional growth
- Diversity and Inclusion
- Competitive compensation for your work
- Making a positive impact to help ultrarare disease patients who are in need of life saving treatments
Sobi is a global company with over 1,800 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. Sobi’s share is listed on Nasdaq Stockholm. More about Sobi at sobi.com 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 firsthand 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 groundbreaking 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 can’t 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.
Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.
Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!
At Sobi, the work we do every day redefines the standards of care and transform the lives of people living with rare diseases.
As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly and always challenging the status quo.
We are committed to an inclusive, sustainable and flexible workplace that fosters growth and development.
- 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 latestage development through commercialization and the full life cycle of our products.
- Accountable for CMC development and ensure ontime and onbudget 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 worldwide.
- Accountable for timely and costeffective scale up and technology transfer to support product launches, geographic expansion and manufacturingtesting 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 crossfunctional collaboration with crossfunctional 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.
- Ph.D. in Chemistry, Biochemistry, Chemical Engineering, or a related field.
- Minimum 10 years of experience in the pharmaceuticalbiotech 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 indepth 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 problemsolving and decisionmaking abilities.
- Strong communication and interpersonal skills, with the ability to collaborate effectively with crossfunctional teams.
- Analytical mindset with the ability to translate data into actionable insights and strategic recommendations.
- Excellent verbal and written communication skills in English
- Emphasis on worklife balance
- Collaborative and teamoriented environment
- Opportunities for professional growth
- Diversity and Inclusion
- Competitive compensation for your work
- Making a positive impact to help ultrarare disease patients who are in need of life saving treatments
Sobi is a global company with over 1,800 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. Sobi’s share is listed on Nasdaq Stockholm. More about Sobi at sobi.com 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 firsthand 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 groundbreaking 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 can’t 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.
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:
Qualifications
Job DescriptionAs 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. Sobi’s products are manufactured within our external network of partners and contract manufacturers and analytical labs. You will also be responsible for an inhouse analytical development lab in Stockholm.
You will work across all levels strategic, tactical, and operational making a tangible impact on Sobi´s mission and longterm 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
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. Sobi’s products are manufactured within our external network of partners and contract manufacturers and analytical labs. You will also be responsible for an inhouse analytical development lab in Stockholm.
You will work across all levels strategic, tactical, and operational making a tangible impact on Sobi´s mission and longterm 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
Required profile
Experience
Other Skills
- Decision Making
- Collaboration
- Communication
- Problem Solving
- Social Skills
- Analytical Thinking
- Teamwork
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