Senior Development Scientist

About Waterford

For more than 20 years, our Waterford team has continued to grow and diversify to serve patients around the world. Today, a team of almost 800 work together at a state-of-the-art biopharmaceutical and medical device campus. Recognised through multiple local and national awards, Sanofi Waterford offers flexible working and access to a world of opportunities to grow your career at one location. As well as attractive benefits, the team enjoy access to an onsite gym and medical centre that underpin a strong commitment to health and wellbeing.

About the job

The Senior Development Scientist works as part of the global MSAT team in the Manufacturing Technologies and Industrialisation (MT&I) department as a technical leader providing support to technology transfers for clinical and commercial products, New Product Introductions and commercial operations at the Waterford Facility and within the global Sanofi network as required.

About Sanofi Business Unit

The multiple national award-winning Sanofi Waterford biopharmaceutical and medical device campus is located in Waterford on Ireland’s southeast coast. Established in 2001 and now with more than 700 employees, the site has seen more than €600m invested in state-of-the-art infrastructure and technology. Diversification and growth continue to bring new products to Waterford and the expanded site portfolio continues to create new opportunities.

Main responsibilities:

As part of the MT&I team

Provide product and technical leadership to cross functional teams for tech transfer programs through scale up, for clinical & commercial product transfer for lyophilised drug products
Provide technical leadership & critical analysis of product during technology transfer & product lifecycle management
Develop data driven strategies for process development / product characterisation
Provide product governance for established commercial products for new process & technology improvements, and operational support from drug products
Lead product investigations with strong understanding of compliance and cGMP, strong scientific judgement and leadership in decision making
Write, review and approve technical reports
Site SME leading the development and integration of the site Control Strategy enabling Lifecycle Management of Product/Process knowledge
Developing and Leading the site training on Control Strategy
Champion and Lead Control Strategy best practices across the site
Support the building and maturing of the site Control Strategy (PCS/OCS) system ensuring informed centralised standardised process/product knowledge is in place for all our products
Develop and own the Site Control Strategy (PCS/OCS) Procedure ensuring compliance with all corporate and regulatory requirements
Coach and develop the Control Strategy SMEs (PCS/OCS)
Interface with process engineers and site's automation team to understand how data is captured and how available data relates to product critical quality attributes and process critical process parameters
Establish and maintain internal / external network relationships in the area of Control Strategy

About you

To excel in this role you will need to be a highly motivated individual to function as a key member of the MSAT group

A minimum of a B.Sc., B.E. or M.Sc./M.Eng. Degree in Biosciences, Pharmaceutical Science, Engineering or equivalent
Demonstrated experience in identifying and resolving complex technical issues
Strong technical writing and communication skills
Solid working knowledge of cGMP’s, GDP, GLP etc.
Significant experience in a cGMP biologics or pharmaceutical manufacturing setting or in lieu of experience equivalent Ph.D or M.Sc. experience

It would be advantageous to have (not essential):

Ph.D or M.Sc. in the relevant field would be advantageous
Experience with aseptic fill finish technology platforms such as formulation, sterilisation, lyophilisation, isolators, filling machines
Experience in Technology Transfers
Good knowledge of statistical techniques in the use of problem solving data analysis
Understanding of the key quality attributes and influencers of physical and chemical stability of biologics based drug products

What Sanofi can offer you:

A role within MSAT will build upon the body of manufacturing product & process knowledge for new products and of current processes within the commercial life cycle management
Cross-functional team leadership provides visibility and exposure to multiple areas in the organization
Opportunity to work within the innovation space at Waterford as part of a lyophilisation Centre of Excellence
Sanofi actively encourages internal career development growth opportunities
A successor position to Manufacturing Team leaders’ positions on the site
Opportunity to join a team with a range of products (pharmaceutical and biological that are marketed globally)
Involvement in supporting clinical trial programmes and transfer to site of new products and technologies
A role where you are instrumental to creating best practice and as the organisation grows, you can too
We offer a generous package including flexible benefits, and are committed to helping you have a healthy work-life balance throughout your career with us
A newly refurbished gym is available onsite for a small and highly competitive annual membership fee
Parking available onsite
This is a full-time role and we support flexible working

Pursue progress. Discover extraordinary.

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

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