Head of Scientific Excellence
- Provide Scientific Expertise to advance CMC comparability strategy and approaches to enable health authority acceptance with evolving regulatory practices and guidance.
- Provide structured approach for modernization initiatives to drive platform excellence for key activities supporting new product introduction and 2nd generation products.
- Material Sciences leadership to drive improvements in material quality and testing standardization (L&E). Leverage supplier partnerships for accelerating technical innovation and efficiency gains for technical project provision.
- Provide oversight on strategies and approaches for cell bank management including testing, qualification and supply security.
- At Sanofi, we have charted a clear path forward to not only minimize the environmental impact across our value chain but also adapt our business to the environmental challenges that we face, promoting Environmental Sustainability by Design through our eco-design approach. This role will drive and execute the strategic direction of Environmental Sustainability by Design initiatives with the organization, fostering a culture of environmental sustainability and innovation in pharmaceutical development.
- PhD/Master’s degree in Life Sciences and/or Chemical Engineering, Biotechnology, Biology, Biochemistry, Pharmacy, or related.
- 10+ years of broad and long-term experience in the biotech/ pharmaceutical industry, specifically in R&D and/or MSAT (industrial development) with manufacturing cGMP considerations, and global CMC projects.
- 5+ years of experience with CMC regulatory guidance specific to process/analytical comparability and health authority submissions.
- 5+ years of leadership experience - Proven capabilities to lead a cross-functional team in a matrix organization. Global exposure and stakeholder management experience.
- Experience with material management including evaluation, change control and testing.
- Specialist knowledge in one or more areas; material sciences, Single-Use technologies (SUT), technical process or analytical platform evaluation.
- Preferred experience with cell bank qualification and management.
- Strong scientific background in biological process development (mammalian and/or microbial) and/or product analytics.
- Good understanding of cGMP requirements and facility operations.
- High experience in exposure to change management and transversal collaboration
- Proven capabilities to lead a cross-functional team in a matrix organization. Global exposure and stakeholder management experience.
- Able to lead and animate networks, teams, experts - Excellent communication and interpersonal skills, stakeholder management skills.
- Strategic thinking: analyzes current and future scenarios, disrupts the status quo with innovation, while remaining pragmatic and focused on priorities.
- Results orientation: Demonstrated ability to drive initiatives from concept to execution.
- High level of autonomy. Comfortable with ambiguity and adapts with high agility.
- People development: Engages and leverages everyone’s strengths while being highly self-aware. Ability to set ambitious goals, communicate & align priorities across the organization.
- Relationship & Influence: able to manage ambiguity and partners without solid reporting line. Ability to influence outside M&S (CMC Dev, Finance and global regulatory)
- Inspires trust through empathy and authenticity. Empowers and recognizes others to create powerful relationships and networks.
- Commit to patients and full product quality. Makes sure the teams understand how to act for patients and customers.
- Issue resolution and decision-making skills.
- 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.
Recommended Jobs
Compliance Analyst
Company Overview KKR is a leading global investment firm that offers alternative asset management as well as capital markets and insurance solutions. KKR aims to generate attractive investment ret…
Front Desk Agent
Job Description Job Description Benefits/Perks Flexible Scheduling Career Advancement Opportunities Competitive Compensation Job Summary We are seeking a positive, friendly Front D…
Manufacturing Technician
Job Description Job Description Description We are seeking a dedicated manufacturing technician to operate production equipment following standard operating procedures (SOPs), Batch Records, M…
Sprinter/Cargo Van Owner Operator
ODYSSEIA Inc . is a carrier company looking for individual sprinters/cargo vans/owner-operators to cooperate with (Independent Contractor Agreement). We're also interested in cooperating with 12-14 …
Software Development Engineer - Generative AI, AGIF | Inference Engine
DESCRIPTION Are you interested in advancing Amazon's Generative AI capabilities? Come work with a talented team of engineers and scientists in a highly collaborative and friendly team. We are buil…
Digital Content Producer - WFXT TV
Location: MA-Boston Job Title: Digital Content Producer - WFXT TV Position Overview WFXT Boston 25 is looking for a Digital Content Producer to join the team! Do you work effectively…
Middle School Boys’ and Girls’ Basketball Head and Assistant Coaches
About The Park School The Park School is a Pre-K to Grade 8 independent school in Brookline, MA dedicated to excellence in education. The cornerstone of Park's program is academic excellence, co…
Senior Client Advisor-Small Business and Tax
Our Company: We care about helping people. Our purpose is to provide help and inspire confidence in our clients and communities everywhere. Our associates feel a sense of belonging in an inclusive pla…