ABOUT THE OPPORTUNITY
As a Sr. Scientist Molecular Biology you will be responsible for oversight of internal and external development and GMP manufacturing of custom plasmids including cells banks.
This role will contribute to the CMC strategy within the cGMP Manufacturing & Supply Group.
This individual should have knowledge of traditional biologics manufacturing processes and analytical characterization. This individual should have knowledge of traditional biologics manufacturing processes as well as plasmid manufacture. This includes cell line selection, master cell banks, working cell banks, upstream cell culture, downstream purification, and analytical characterization.
The scientist should also understand working in an FDA regulated environment and producing materials under cGMP's for human use.
Finally, the individual should have the knowledge capable of serving as a technical Subject Matter Expert for an internalization of such manufacturing efforts.
In this role you will:
Serve as lead technical representative to ensure critical raw material supplies are manufactured to phase-appropriate technical specifications , Evaluate & Qualify material change.
Serve as the technical subject matter expert for Technical Operations on GMP production of linearized plasma DNA and enzymes used the manufacturing of mRNA drug substance.
Oversee the technology transfer and outsourcing of critical biological reagents and characterization to CMO's/CRO's. This will include vendor identification, evaluation, and selection while ensuring alignment with the drug substance and drug product timelines.
Review CMO/CRO batch records for pDNA & Cells banks to ensure robust processes are developed that are capable of meeting quality standards.
Ability to provide technical support and resolve scale-up and manufacturing issues, develop solutions to improve process efficiency and product quality, provide technical expertise in OOS / deviation investigation.
Work with Analytical Development and Quality Control to ensure characterization, including stability, of critical reagents is comprehensive.
Review and edit contract, supply agreements, statements of work, etc.
Support and contribute to Regulatory filings as well as other regulatory documentation.
Work with Supply Chain to support Vendor Change Notifications , and closeout of Change Controls .
Qualifications/ Education & work experience
A PhD in Molecular Biology, Biochemical Engineering, or related field with 3+ years relevant industry experience.
Knowledge and experience with GMP production of plasmid DNA and associated purification processes.
Expertise in the creation and maintenance of regulatory compliant Working and Master Cell Banks
Experience in vendor search, evaluation, selection, and management.
Strong familiarity with cGMP and ICH Guidelines
Ability to work independently and effectively.
Uses leading-edge knowledge of principles, concepts, and practices and/or techniques to lead complex projects within a department team.
Strong problem-solving abilities.
Ability to prioritize and deliver on tight timelines
Strong written and oral communications skills, with demonstrated experience in cross-functional and timely communication.
Highly organized, exceptional attention to detail, and strong proficiency in documentation skills.
Results oriented and demonstrated a focus on achieving (business) results.
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.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
According to the CDC, an individual is considered to be "fully vaccinated" fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.
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.