With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical force, listed on the Italian stock exchange, with over 4,300 employees.
We are a group of like-minded, passionate individuals who go to extraordinary lengths for our partners, customers, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.
At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves.
This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases.
Recordati. Unlocking the full potential of life
Role description
With over a decade of experience in the Pharma/Biotech industry, candidates for this role will be dynamic leaders known for innovation, with proven track records in leading global technology transfer projects. Applicants will possess advanced project management skills, be proficient in leading diverse teams and engaging with stakeholders across all levels.
The successful applicant will join the Corporate Industrial Operation Technology Transfer Group, where they will spearhead the international team focused on the technology transfer of pharma/biotech products within the Recordati portfolio and for new pharma/biotech potential product acquisitions. Additionally, they will supervise critical manufacturing initiatives with Recordati contract manufacturers, striving to achieve strategic and operational goals by optimizing processes and generating cost savings for the organization.
Recordati welcomes applications from internal candidates based in Europe where the company has key sites, i.e. France, UK, Italy, Switzerland or the US, (ideally East Coast) with international travel required on a regular basis.
Key responsibilities:
Technical Transfer Management
• Develop and execute project plans to effectively manage all technical or technology transfer activities from inception to completion.
• Apply expertise to ensure compliance and suitability of all CMC and technical processes.
• Utilize expertise to identify and validate vendors for managing biological manufacturing processes, ensuring equivalence in materials, equipment, and suppliers between transferring and receiving sites.
• Collaborate with external technical teams from pharmaceutical/biotechnology companies and CMOs to thoroughly understand technical elements and key product characteristics before developing technology transfer plans and initiating handover to selected CMOs.
• Establish and nurture trust-based relationships with both the product divestor/sender and the receiving CMO, fostering successful collaboration and optimizing the transfer process.
• Conduct site visits to both the divestor/sending plant and the CMO receiving plant to assess the alignment of core skills and competencies.
• Ensure that the transfer of process information and capabilities between the donor and recipient sites complies with all the regulatory requirements in terms of efficacy, quality and safety.
• Proven problem solving skills and ability to bring solutions to issues that may be encountered.
Project/Programme Management
• Apply project management methodologies and processes, considering budgets, resource availability, and organizational and external CMO capacities to attain project goals.
• Implement technology transfer methodologies to guarantee that the journey from project initiation to project completion recognizing the necessary infrastructure for product market entry.
• Execute a comprehensive tech transfer plan or equivalent tools to document the decision-making process for executing technical transfer.
• Implement risk management and impact analysis tools to identify barriers to achieving key milestones, implement mitigation strategies to ensure all risks are identified prior to transfer.
Technical Knowledge Management
• Build a portfolio of information on current technology for mammalian/bacterial fermentation and purification processes, chemical synthesis processes and secondary manufacturing techniques.
• Stay up to date with current trends in the industry and be aware of new advances in technology that could introduce efficiencies to new or existing manufacturing processes.
Technical / Professional Expertise required
• CMC experience in mammalian cell expression.
• Experience of perfusion and fed batch processes for the production of monoclonal antibodies,
protein therapeutics and vaccines is desirable.
• Experience in biologics drug substance and drug product manufacture.
• Greater than 5 years’ experience of product technical transfer, between manufacturing sites and between countries.
• Greater than 5 years’ project management experience in the Pharma/Biotech environment
• Risk analysis and impact analysis experience.
• Experience in identification and selection of vendors and sub-contractors.
Personal Specification
• Scientific Degree qualified.
• Project management qualification desirable.
• Fluent in English. Additional European languages would be useful.
• Driven, self-starter who is delivery focused and possesses effective leadership skills.
• Ability to achieve results in a dynamic changing environment.
At Recordati we believe in people! Inspired by our purpose – unlocking the full potential of life – we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.
We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.
If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.
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internals state-of-the-art technologies Impact analysis Project management Risk analysis