الصفحة الرئيسية أيرلندا Senior Development Scientist (MSAT)
الصفحة الرئيسية أيرلندا Senior Development Scientist (MSAT)
Senior Development Scientist (MSAT)
في sanofi
في
Ireland
نُشرت يوم January 8, 2024
تفاصيل الوظيفة
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Senior Development Scientist (MSAT)
Apply locations Waterford time type Full time posted on Posted 30+ Days Ago job requisition id R2718764Senior 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
- 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
- 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. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !#LI-EUR At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.About Us
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting or via our movie We are SanofiWhy Sanofi
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. #J-18808-LjbffrApply safely
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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. </i></p><h3><b> About the job </b></h3><p> 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. </p><h3><b> About Sanofi Business Unit </b></h3><p> 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. </p><p><b> Main responsibilities: </b></p><p> As part of the MT&I team </p><ul><li> 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 </li><li> Provide technical leadership & critical analysis of product during technology transfer & product lifecycle management </li><li> Develop data driven strategies for process development / product characterisation </li><li> Provide product governance for established commercial products for new process & technology improvements, and operational support from drug products </li><li> Lead product investigations with strong understanding of compliance and cGMP, strong scientific judgement and leadership in decision making </li><li> Write, review and approve technical reports </li><li> Site SME leading the development and integration of the site Control Strategy enabling Lifecycle Management of Product/Process knowledge </li><li> Developing and Leading the site training on Control Strategy </li><li> Champion and Lead Control Strategy best practices across the site </li><li> 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 </li><li> Develop and own the Site Control Strategy (PCS/OCS) Procedure ensuring compliance with all corporate and regulatory requirements </li><li> Coach and develop the Control Strategy SMEs (PCS/OCS)</li><li> 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 </li><li> Establish and maintain internal / external network relationships in the area of Control Strategy </li></ul><h3><b> About you </b></h3><p> To excel in this role you will need to be a highly motivated individual to function as a key member of the MSAT group </p><ul><li> A minimum of a B.Sc ., B.E. or M.Sc ./M.Eng. Degree in Biosciences, Pharmaceutical Science, Engineering or equivalent </li><li> Demonstrated experience in identifying and resolving complex technical issues </li><li> Strong technical writing and communication skills </li><li> Solid working knowledge of cGMP’s, GDP, GLP etc. </li><li> Significant experience in a cGMP biologics or pharmaceutical manufacturing setting or in lieu of experience equivalent Ph.D or M.Sc. experience </li></ul><p> It would be advantageous to have (not essential): </p><ul><li> Ph.D or M.Sc. in the relevant field would be advantageous </li><li> Experience with aseptic fill finish technology platforms such as formulation, sterilisation, lyophilisation, isolators, filling machines </li><li> Experience in Technology Transfers </li><li> Good knowledge of statistical techniques in the use of problem solving data analysis </li><li> Understanding of the key quality attributes and influencers of physical and chemical stability of biologics based drug products </li></ul><p><b> What Sanofi can offer you: </b></p><ul><li> 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 </li><li> Cross-functional team leadership provides visibility and exposure to multiple areas in the organization </li><li> Opportunity to work within the innovation space at Waterford as part of a lyophilisation Centre of Excellence </li><li> Sanofi actively encourages internal career development growth opportunities </li><li> A successor position to Manufacturing Team leaders’ positions on the site </li><li> Opportunity to join a team with a range of products (pharmaceutical and biological that are marketed globally)</li><li> Involvement in supporting clinical trial programmes and transfer to site of new products and technologies </li><li> A role where you are instrumental to creating best practice and as the organisation grows, you can too </li><li> 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 </li><li> A newly refurbished gym is available onsite for a small and highly competitive annual membership fee </li><li> Parking available onsite </li><li> This is a full-time role and we support flexible working </li></ul><h3> Pursue <i> progress </i> . Discover <i> extraordinary </i> . </h3><p> 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. </p><p> 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. </p><p> Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !</p><p>#LI-EUR </p> <p> At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. </p> <h3> About Us </h3><p> Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. </p><p> With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting or via our movie We are Sanofi </p><h3> Why Sanofi </h3><p> As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. 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'default_language' => 'en', 'country_time_zone' => 'Asia/Colombo', 'job_location' => '1', 'published' => '1', 'show' => '1' ), 'united-kingdom' => array( 'name' => 'United Kingdom', 'country_id' => '74', 'country_code' => 'gb', 'slug' => 'united-kingdom', 'global_location_id' => '226', 'rel_gloc_ids' => '226,1035,1036,1037,1038,1039,1040,1041,1042,1043,1044,1045,1046,1050,1259,1260,1261,1267', 'currency' => 'GBP', 'currency_name' => 'British Pound', 'languages' => 'en', 'default_language' => 'en', 'country_time_zone' => 'Europe/London', 'job_location' => '1', 'published' => '1', 'show' => '1' ), 'malaysia' => array( 'name' => 'Malaysia', 'country_id' => '149', 'country_code' => 'my', 'slug' => 'malaysia', 'global_location_id' => '131', 'rel_gloc_ids' => '131,131,980,1051', 'currency' => 'MYR', 'currency_name' => 'Ringgit', 'languages' => 'en', 'default_language' => 'en', 'country_time_zone' => 'Asia/Kuala_Lumpur', 'job_location' => '1', 'published' => '1', 'show' => '1' ), 'nepal' => 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'currency_name' => 'New Zealand Dollar', 'languages' => 'en', 'default_language' => 'en', 'country_time_zone' => 'Pacific/Auckland', 'job_location' => '0', 'published' => '1', 'show' => '1' ), 'brasil' => array( 'name' => 'Brasil', 'country_id' => '29', 'country_code' => 'br', 'slug' => 'brasil', 'global_location_id' => '30', 'rel_gloc_ids' => '30,1000,1001,1002,1003,1004,1005,1006,1007,1008,1009,1010,1011,1012,1013', 'currency' => 'BRL', 'currency_name' => 'Brazilian Real', 'languages' => 'pt', 'default_language' => 'pt', 'country_time_zone' => 'America/Sao_Paulo', 'job_location' => '0', 'published' => '1', 'show' => '1' ), 'portugal' => array( 'name' => 'Portugal', 'country_id' => '175', 'country_code' => 'pt', 'slug' => 'portugal', 'global_location_id' => '174', 'rel_gloc_ids' => '174,1014,1015,1087,1088,1089,1090', 'currency' => 'EUR', 'currency_name' => 'Euro', 'languages' => 'pt', 'default_language' => 'pt', 'country_time_zone' => 'Europe/Lisbon', 'job_location' => '0', 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'Course' => array( 'id' => '94874', 'seeder_id' => '0', 'edited_seeder_id' => '43', 'edited_client_id' => '8766', 'title' => 'Certificate in Wedding & Event Management', 'external_link' => 'https://www.johnacademy.co.uk/course/certificate-in-wedding-event-management-level-2/', 'objectives' => null, 'photo_cta' => null, 'photo' => null, 'length' => '', 'next_session' => '', 'schedules' => null, 'duration' => 'Upto 25 Hours', 'base_duration' => '0', 'timing' => 'Flexible', 'location' => 'Online', 'global_location_id' => '275', 'school' => 'John Academy', 'logo' => '', 'certificate_diploma' => 'yes', 'image' => '', 'brochure_url' => null, 'video' => '', 'cost' => '', 'price' => '20', 'price_enquiry' => '0', 'course_status' => 'Paid', 'base_price' => '20', 'nondiscounted_base_price' => '285.71', 'currency' => 'GBP', 'discount' => '%93 خصم لعملاء ليمون!', 'free_trial_text' => '', 'laimoon_offer' => '1', 'summary' => 'The wedding is an important event to anyone since it symbolises the start of a new phase of life. However, wedding events can be very stressful since there are lots of preparations which needed to be done. In this course, you will learn how to deal with wedding planning and preparation. You will be introduced to the basics of wedding planning and how to do a wedding on a budget. You will then be able to learn how to save money but still plan the best wedding which you or your client can ever dream of. You would also know how to plan honeymoon adventure that any newlyweds will enjoy.<br /> <br /> <strong>COURSE CURRICULUM<br /> Event Management</strong> <ul> <li> Event Planning Essentials</li> <li> Budgeting Basics</li> <li> Using the Committee Approach</li> <li> Connecting with Partners and Sponsors</li> <li> Advertising and Marketing</li> <li> Selecting the Venue</li> <li> Feeding the Masses</li> <li> Business Etiquette Basics</li> <li> Celebrating Diversity</li> <li> Creating an Atmosphere of Service</li> <li> Selecting Speakers and a Master of Ceremonies</li> <li> Managing Contracts</li> <li> Gathering Feedback</li> <li> Event Day Roles</li> <li> Closing the Event</li> </ul> <strong>Wedding Management</strong> <ul> <li> Introduction</li> <li> Wedding Planning On A Budget</li> <li> Wedding Attire Money Saving Tips</li> <li> Reception Cash Saving Tips</li> <li> Reception Dinner Budget Saving Tips</li> <li> Planning Catering for Your Wedding</li> <li> Saving Money On Buying Flowers</li> <li> Photography And Videography Cash Savers</li> <li> Your Honeymoon Adventure</li> <li> Conclusion: Final Thoughts</li> <li> Wedding Planning Checklist</li> </ul> <strong>Planning the Event</strong> <ul> <li> 9 Key Ideas To Make Your Event A Successful One</li> <li> What You Need To Know To Make Your Event Educational, Entertaining and Memorable!</li> <li> 8 Ways To Incorporate Entertainment Elements Into Your Events Without Spending A Bomb!</li> <li> What To Look Out For When Planning Your Next Offsite Event</li> <li> The Nuts & Bolts Of Events Logistics</li> <li> Working With Team Building Elements In Your Offsite Events</li> <li> How To Create Effective Team bonding At Your Events</li> <li> Managing An Event For 10 people versus 100 !</li> <li> 10 Ways To Make Your Event Interesting And Exciting</li> <li> 8 Tips To Transform Your Event Venue</li> <li> 7 Ways For An Easy & Hassle-Free Meeting Planning</li> <li> 8 Tips On How To Generate Fun Ideas When Planning Your Event</li> <li> How To Attract The Right People To Your Event</li> <li> 9 Reasons Why You Should Be Nice To Your Event Suppliers</li> <li> How & Where To Find Suppliers That Will Move Mountains For You!</li> <li> 10 Tips On How To Be An Excellent Event Planner</li> <li> 8 Key Success Factors When Marketing Your Event</li> <li> Marketing Managers: 10 Reasons Why You Should Organize Your Own Events</li> <li> 6 Factors To Look Out For When Planning The Event Itinerary</li> <li> What Makes An Event Fabulous?</li> <li> 7 Key Reasons Why Events Marketing Should Be Part Of Your Marketing Strategy</li> <li> Learn What It Takes To Be A Successful Event Planner</li> <li> Truth About Creating Successful Events!</li> <li> When You Need An Event Planner And When You Don’t!</li> <li> What To Look Out For When Choosing Your Event Planner</li> <li> What To Do When Things Don’t Go As Planned During Events</li> <li> When You Need To Hire An Event Planner?</li> <li> 10 Ideas On Creating Exciting Event Themes</li> <li> 8 Ways To Get Attendees To Your Events</li> <li> Having Mascots, Minglers, Entertainers At Your Next Event – How To Find & Work With Them</li> <li> 8 Key Factors Of A Successful Event Planner – Learn To Pick Wisely</li> <li> 9 Ways To Organize Your Events On A Shoestring Budget</li> <li> Effective Ways To Negotiate With Your Event Suppliers</li> <li> 7 Tips On How To Find The Right Venue For Your Next Event</li> <li> 8 Ways To Work Successfully With Your Event Venue</li> </ul> <strong>Recommended Reading</strong> <ul> <li> Recommended Reading : Certificate in Wedding & Event Management -Level 2</li> </ul> <strong>Assessment and Certification: </strong><br /> Upon completion of the course, you will be required to sit an online multiple-choice test. Your test will be assessed automatically and the results will be given to you immediately. Before sitting your final exam you will have the opportunity to test your proficiency with a mock exam. 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However, wedding events can be very stressful since there are lots of preparations which needed to be done. In this course, you will learn how to deal with wedding planning and preparation. You will be introduced to the basics of wedding planning and how to do a wedding on a budget. You will then be able to learn how to save money but still plan the best wedding which you or your client can ever dream of. You would also know how to plan honeymoon adventure that any newlyweds will enjoy.<br /> <br /> <strong>COURSE CURRICULUM<br /> Event Management</strong> <ul> <li> Event Planning Essentials</li> <li> Budgeting Basics</li> <li> Using the Committee Approach</li> <li> Connecting with Partners and Sponsors</li> <li> Advertising and Marketing</li> <li> Selecting the Venue</li> <li> Feeding the Masses</li> <li> Business Etiquette Basics</li> <li> Celebrating Diversity</li> <li> Creating an Atmosphere of Service</li> <li> Selecting Speakers and a Master of Ceremonies</li> <li> Managing Contracts</li> <li> Gathering Feedback</li> <li> Event Day Roles</li> <li> Closing the Event</li> </ul> <strong>Wedding Management</strong> <ul> <li> Introduction</li> <li> Wedding Planning On A Budget</li> <li> Wedding Attire Money Saving Tips</li> <li> Reception Cash Saving Tips</li> <li> Reception Dinner Budget Saving Tips</li> <li> Planning Catering for Your Wedding</li> <li> Saving Money On Buying Flowers</li> <li> Photography And Videography Cash Savers</li> <li> Your Honeymoon Adventure</li> <li> Conclusion: Final Thoughts</li> <li> Wedding Planning Checklist</li> </ul> <strong>Planning the Event</strong> <ul> <li> 9 Key Ideas To Make Your Event A Successful One</li> <li> What You Need To Know To Make Your Event Educational, Entertaining and Memorable!</li> <li> 8 Ways To Incorporate Entertainment Elements Into Your Events Without Spending A Bomb!</li> <li> What To Look Out For When Planning Your Next Offsite Event</li> <li> The Nuts & Bolts Of Events Logistics</li> <li> Working With Team Building Elements In Your Offsite Events</li> <li> How To Create Effective Team bonding At Your Events</li> <li> Managing An Event For 10 people versus 100 !</li> <li> 10 Ways To Make Your Event Interesting And Exciting</li> <li> 8 Tips To Transform Your Event Venue</li> <li> 7 Ways For An Easy & Hassle-Free Meeting Planning</li> <li> 8 Tips On How To Generate Fun Ideas When Planning Your Event</li> <li> How To Attract The Right People To Your Event</li> <li> 9 Reasons Why You Should Be Nice To Your Event Suppliers</li> <li> How & Where To Find Suppliers That Will Move Mountains For You!</li> <li> 10 Tips On How To Be An Excellent Event Planner</li> <li> 8 Key Success Factors When Marketing Your Event</li> <li> Marketing Managers: 10 Reasons Why You Should Organize Your Own Events</li> <li> 6 Factors To Look Out For When Planning The Event Itinerary</li> <li> What Makes An Event Fabulous?</li> <li> 7 Key Reasons Why Events Marketing Should Be Part Of Your Marketing Strategy</li> <li> Learn What It Takes To Be A Successful Event Planner</li> <li> Truth About Creating Successful Events!</li> <li> When You Need An Event Planner And When You Don’t!</li> <li> What To Look Out For When Choosing Your Event Planner</li> <li> What To Do When Things Don’t Go As Planned During Events</li> <li> When You Need To Hire An Event Planner?</li> <li> 10 Ideas On Creating Exciting Event Themes</li> <li> 8 Ways To Get Attendees To Your Events</li> <li> Having Mascots, Minglers, Entertainers At Your Next Event – How To Find & Work With Them</li> <li> 8 Key Factors Of A Successful Event Planner – Learn To Pick Wisely</li> <li> 9 Ways To Organize Your Events On A Shoestring Budget</li> <li> Effective Ways To Negotiate With Your Event Suppliers</li> <li> 7 Tips On How To Find The Right Venue For Your Next Event</li> <li> 8 Ways To Work Successfully With Your Event Venue</li> </ul> <strong>Recommended Reading</strong> <ul> <li> Recommended Reading : Certificate in Wedding & Event Management -Level 2</li> </ul> <strong>Assessment and Certification: </strong><br /> Upon completion of the course, you will be required to sit an online multiple-choice test. Your test will be assessed automatically and the results will be given to you immediately. Before sitting your final exam you will have the opportunity to test your proficiency with a mock exam. 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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. </i></p><h3><b> About the job </b></h3><p> 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. </p><h3><b> About Sanofi Business Unit </b></h3><p> 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. </p><p><b> Main responsibilities: </b></p><p> As part of the MT&I team </p><ul><li> 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 </li><li> Provide technical leadership & critical analysis of product during technology transfer & product lifecycle management </li><li> Develop data driven strategies for process development / product characterisation </li><li> Provide product governance for established commercial products for new process & technology improvements, and operational support from drug products </li><li> Lead product investigations with strong understanding of compliance and cGMP, strong scientific judgement and leadership in decision making </li><li> Write, review and approve technical reports </li><li> Site SME leading the development and integration of the site Control Strategy enabling Lifecycle Management of Product/Process knowledge </li><li> Developing and Leading the site training on Control Strategy </li><li> Champion and Lead Control Strategy best practices across the site </li><li> 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 </li><li> Develop and own the Site Control Strategy (PCS/OCS) Procedure ensuring compliance with all corporate and regulatory requirements </li><li> Coach and develop the Control Strategy SMEs (PCS/OCS)</li><li> 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 </li><li> Establish and maintain internal / external network relationships in the area of Control Strategy </li></ul><h3><b> About you </b></h3><p> To excel in this role you will need to be a highly motivated individual to function as a key member of the MSAT group </p><ul><li> A minimum of a B.Sc ., B.E. or M.Sc ./M.Eng. Degree in Biosciences, Pharmaceutical Science, Engineering or equivalent </li><li> Demonstrated experience in identifying and resolving complex technical issues </li><li> Strong technical writing and communication skills </li><li> Solid working knowledge of cGMP’s, GDP, GLP etc. </li><li> Significant experience in a cGMP biologics or pharmaceutical manufacturing setting or in lieu of experience equivalent Ph.D or M.Sc. experience </li></ul><p> It would be advantageous to have (not essential): </p><ul><li> Ph.D or M.Sc. in the relevant field would be advantageous </li><li> Experience with aseptic fill finish technology platforms such as formulation, sterilisation, lyophilisation, isolators, filling machines </li><li> Experience in Technology Transfers </li><li> Good knowledge of statistical techniques in the use of problem solving data analysis </li><li> Understanding of the key quality attributes and influencers of physical and chemical stability of biologics based drug products </li></ul><p><b> What Sanofi can offer you: </b></p><ul><li> 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 </li><li> Cross-functional team leadership provides visibility and exposure to multiple areas in the organization </li><li> Opportunity to work within the innovation space at Waterford as part of a lyophilisation Centre of Excellence </li><li> Sanofi actively encourages internal career development growth opportunities </li><li> A successor position to Manufacturing Team leaders’ positions on the site </li><li> Opportunity to join a team with a range of products (pharmaceutical and biological that are marketed globally)</li><li> Involvement in supporting clinical trial programmes and transfer to site of new products and technologies </li><li> A role where you are instrumental to creating best practice and as the organisation grows, you can too </li><li> 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 </li><li> A newly refurbished gym is available onsite for a small and highly competitive annual membership fee </li><li> Parking available onsite </li><li> This is a full-time role and we support flexible working </li></ul><h3> Pursue <i> progress </i> . Discover <i> extraordinary </i> . </h3><p> 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. </p><p> 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. </p><p> Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !</p><p>#LI-EUR </p> <p> At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. </p> <h3> About Us </h3><p> Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. </p><p> With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting or via our movie We are Sanofi </p><h3> Why Sanofi </h3><p> As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. 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الشركة المعلنة عن الوظيفة
Sanofi
Sanofi multinational pharmaciieutical company in Egypt
Ibd3a Academy in Egypt
Brooklen Academy
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