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MSAT Product Specialist

ID:  1033
Date of Posting:  Oct 7, 2024
Business Area:  Technical Operations
Job Type:  Direct Employee
On site / Remote / Hybrid:  Hybrid
Location: 

Hemel Hempstead, GB

Territory: 
Full-Time or Part-Time:  Full Time
Seniority:  Associate

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.

Job Purpose

Primary: This role will provide technical support and product expertise to the MSAT team to assist with the technology transfer of commercial biologics manufacturing processes from external partners to new external CDMO’s and partners.

Secondary: Additionally, the role provides support for life cycle management of all the products in Recordati’s portfolio, across multiple phases of development and therapeutic areas.

This role will involve working with the global teams and external third-party networks. This role is an individual contributor role with no line management responsibilities.

Reporting to the director of MSAT, this role will allow the successful candidate to be a key player in securing the future supply of key biologics for the treatment of orphan indications and rare diseases. This role gives the successful candidate the ability to grow both technically and personally within a fast-paced, multi-functional environment. It is anticipated that the role will continue to expand and grow in responsibility with the expansion of Recordati’s portfolio of products and is anticipated to present opportunities to take principal responsibility for individual projects and activities.

As the successful candidate will be working with globally located CDMO’s and partners some occasional travel may be required.

Key Responsibilities

Technology Transfer:

  • Assist with, and provide technical expertise to support the operational technology transfer activities at CDMO’s and partner organisations for long term manufacturing and supply of biological products
  • Generate internal reports and review documentation supporting technology transfer (e.g., master plans and reports, process descriptions, detailed gap assessments, as appropriate)
  • Generate options to resolve technical challenges and present them for endorsement
  • Capture, trend, and analyse process generated batch data to support process improvements and life cycle management
  • Perform review of manufacturing documentation generated by the receiving unit (manufacturing records, batch sheets, study protocols, SOPs, etc.) to ensure accuracy and suitability.

Manufacturing Process:

  • Have a demonstrable understanding of biological USP, DSP and Drug Product manufacturing processes (ideally with one or more, including; analytical, validation, shipping and supply chain requirements), technology transfers and CMC regulatory
  • The ability to network and develop authentic high performing working relationships will be highly regarded. This will have a requirement of being able to express ideas and activities to a wide type of backgrounds
  • The ability to operate strategically ensuring that project progression is performed holistically with the product and patient being central to every decision and action.

#LI-KL1

Required Education

Minimum, associate degree in a science related field, preferably in a life science discipline

Required Skills and Experience

Minimum of 3 years industry experience gained in a pharmaceutical related field with exposure to biological products

Demonstrable experience working virtually and remotely is desirable.

Technical Competencies

  • CMC specific knowledge and a strong understanding of analytical methods, manufacturing, process development, quality control and quality assurance related to biologics
  • Experience in technology transfer of GMP biologics manufacturing processes
  • Ability to work in a fast-paced environment while retaining a high attention to detail and quality
  • Experience in working with third party manufacturing and testing partners
  • An understanding of process validation and the regulatory challenges required for the manufacture of commercial products

Required Behaviours and Competencies

  • Excellent oral and written communication skills in English
  • Strong interpersonal, collaborative, problem solving and conflict resolution skills
  • Ability to develop solutions to technical and organizational issues to improve performance and productivity.

Required Languages

English both oral and written.

Travel required in %

30%

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.

Apply now »