mRNA GMP Workflow Manager - Vaccine
mRNA GMP Workflow Manager - Vaccine
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mRNA Center of Excellence Workflow Manager - Vaccine
In the race for the future of health – The Sanofi mRNA Center of Excellence (CoE)
At Sanofi, we chase the miracles of science, and we know mRNA has a role to play in the future of health. And while the pandemic has shaken up our industry, creating new opportunities and risks, we believe the acceleration of innovation with mRNA technology means vaccines and treatments for more people faster than before.
That’s why we’re looking for bold, optimistic world-changers to join our mRNA Center of Excellence. We’re investing €400m a year into the new Center, hiring a team of 450 dedicated employees, and focusing on implementing an integrated end-to-end mRNA vaccine capabilities and research with R&D, digital and CMC teams.
Bring your ambition and optimism and join us on our journey to discover and deliver transformative medicine to patients through the advancement of our cutting-edge mRNA technology!
Intro about the Position; About the Opportunity
The mRNA Workflow manager within mRNA Center of Excellence will be responsible for management of workflow to support GMP activities related to Raw materials and product supporting Analytical Development CMC activities for preclinical through late-stage development programs.
The ideal candidate will have relevant experience and a track record of accomplishments in the life sciences/ pharmaceutical/biotechnology industry.
The mRNA workflow coordinator guarantees project execution in terms of costs, deadlines and quality, in compliance with the group/site’s HSE policies and relevant regulations. He/she is a referent in the field of RM & he/she is a key actor in interfacing with external collaborations and other partners functions within Sanofi.
Key Responsibilities for Position; about growing with us for winning with us
In this role you will….
Collaborate sample and documentation workflow with the QC manager, RM leader, Stability Manager, SME and other project managers to align timelines and ensure milestones for analytical activities are met.
Ensure strong interfaces between entities.
Raw Materials, ensure raw material availability for clinical batch manufacturing:
Contribute to the writing & reviewing documentation to support analyses (Specifications, Control Request Form, Sampling rules and Sampling Plan).
Ensure sample availability for QC testing according to project timelines.
Coordinate interfaces with all actors to secure sampling rules implementation and sample workflow & storage.
Clinical Batches, ensure manufacturing start on time:
Coordinate planning meetings with all actors involved in the process (Manufacturer, Laboratories, Stability, Quality, CMC Analytical Leader, Technico-Regulatory Responsible, LIMS Team):
Contribute to the writing & reviewing of documentation to support analyses (Specifications, Control Request Form, Sampling Plan).
Coordinate activities to support Lims setting on time by coordinating activities by documentation availability (Master data sheet, stability protocol, sampling plan, specification…)
Verify Lims setting before providing an available LIMS product for manufacturing.
Qualifications/ Education & Work Experience
BS (10+) or MS (7+) years of relevant experience in the biopharmaceutical or CRO industry.
BS or MS degree in chemical, biomedical, biochemical, or process engineering, chemistry, materials sciences, or formulation sciences, coupled with an understanding of analytical chemistry.
Excellent organizational skills with great attention to detail.
Strong interpersonal skills, self-awareness and ability to manage team dynamics.
Strong written and oral communication skills, with some experience managing cross-functional communication.
Strong and collaborative work ethic. Results oriented and demonstrates a focus on achieving (business) results.
Ability to facilitate meetings, enhance team communication, support decision making, influence outcomes, and ensure alignment among internal and external stakeholders.
Knowledge and understanding of laboratory terminology, good documentation, and good laboratory practices.
Excellent knowledge with all aspects of MS Office including MS Project and Visio, Sharepoint and MS Teams.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; 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.
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.