What are the responsibilities and job description for the Associate Director, Genomic Medicine Purification Process Development position at Lensa?
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Job Title: Associate Director, Genomic Medicine Purification Process Development
Location: Waltham, MA
Work Model: M-F onsite
About The Job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
The Genomic Medicine Unit (GMU) CMC group at Sanofi is dedicated to the establishment of best-in-class manufacturing platforms to support development of life-changing advanced gene therapy products, including recombinant AAV vectors and non-viral LNP particles. Sanofi is looking for an experienced purification process development professional with experience in GMP manufacturing and technology transfer (TT) to join the GMU Purification Process Development (PPD) Group located in Waltham, MA in the role of Associate Director. The GMU PPD group operates with the mission to develop robust, scalable, and innovative viral vector purification processes for Sanofi's genomic medicine pipeline.
The successful candidate will work with a group of scientists and engineers responsible for the development of viral vector purification processes, technology transfer to manufacturing sites, overseeing process scaling up, defining scale down models, and associated regulatory filing activities. We are looking for a candidate with excellent scientific, communication, and project management skills.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started??
Main Responsibilities
Basic Qualifications
#GD-SA
#vhd
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, ability or gender identity.
Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
North America Applicants Only
The Salary Range For This Position Is
$147,000.00 - $212,333.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) .
Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/)
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 www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)
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.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
If you have questions about this posting, please contact support@lensa.com
Job Title: Associate Director, Genomic Medicine Purification Process Development
Location: Waltham, MA
Work Model: M-F onsite
About The Job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
The Genomic Medicine Unit (GMU) CMC group at Sanofi is dedicated to the establishment of best-in-class manufacturing platforms to support development of life-changing advanced gene therapy products, including recombinant AAV vectors and non-viral LNP particles. Sanofi is looking for an experienced purification process development professional with experience in GMP manufacturing and technology transfer (TT) to join the GMU Purification Process Development (PPD) Group located in Waltham, MA in the role of Associate Director. The GMU PPD group operates with the mission to develop robust, scalable, and innovative viral vector purification processes for Sanofi's genomic medicine pipeline.
The successful candidate will work with a group of scientists and engineers responsible for the development of viral vector purification processes, technology transfer to manufacturing sites, overseeing process scaling up, defining scale down models, and associated regulatory filing activities. We are looking for a candidate with excellent scientific, communication, and project management skills.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started??
Main Responsibilities
- Have extensive knowledge of GMP manufacturing and technology transfer to manufacturing sites
- Make strong technical and strategic contributions to cross functional project teams
- Subject matter expert for executing technology transfers to external CDMOs
- Act as the first/primary point of contact for familiarization and staying current with CDMO technical capabilities and limitations, including but not limited to equipment, instrumentation, facility, process fit, and engineering design.
- Execute and improve the established standard ways of working and harmonize TT practices across programs and CDMOs. Examples of standard work include creating templates for TT risk and gap assessments, process descriptions, etc.
- Closely collaborate and stay current with internal process development to ensure external transfer is aligned with internal development efforts, and vice versa. Advise where studies or changes are required to address gaps
- Actively engaged with internal pilot scale up labs to identify operation gaps and streamline ways of working and actively participate in the execution of internal pilot batches.
- Actively participate internal and external project teams and subteams to enable the above responsibilities
- Serve as a primary representative for Person-in-Plant (PiP) responsibilities to oversee CDMO activities during GMP runs
- Requires the ability to travel more than 20% of the time
Basic Qualifications
- PhD degree in Biotechnology, Cell Biology, Biochemistry, Chemistry, Chemical Engineering or related discipline with a minimum of 8 years of relevant industry experience or a Master's degree with a minimum of 10 years of industry experience or a Bachelor's degree with a minimum of 12 years of relevant industry experience.
- Background specializing in Technology Transfers and new product introductions to GMP facilities
- Strong technical background in AAV purification process
- Experience with AAV cGMP Manufacturing, especially in purification operations
- Experience of engaging external CDMOs within the biopharmaceutical industry
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
#GD-SA
#vhd
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, ability or gender identity.
Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
North America Applicants Only
The Salary Range For This Position Is
$147,000.00 - $212,333.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) .
Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/)
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 www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)
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.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
If you have questions about this posting, please contact support@lensa.com
Salary : $147,000 - $212,333