Sanofi · 1 day ago
Manager Senior Process Engineer- Vaccines
Swiftwater, PA
Full-time
Onsite
Senior Level, Lead/Staff
10+ years exp
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Responsibilities
Function as the platform’s Drug Product and Buffer Formulation SPP.
Lead and deliver technical studies and validation strategies for Manufacturing assist, Technology Transfers and New Vaccines formulation operations.
Provide Shop Floor assistance to support investigations, troubleshooting, CAPA and Change Control activities.
Author / review / approve process design specifications and validation project plans.
Author / review / approve technical documents which support project execution and manufacturing assistance.
Participate, support, defend and provide technical expertise during Pre-Approval Inspections and agency inspections when required to defend studies.
Having a strong working knowledge of the relationship between Drug Product and buffer formulation characteristics and critical quality attributes.
Working with different disciplines (Quality, Manufacturing Operations, Regulatory Affairs, and Engineering) in the execution of development and validation studies to industrialize processes for clinical and licensed products to assure commercialization of robust, compliant, and efficient processes for vaccines and biopharmaceuticals.
Participating in programs that use structured methodologies such as Quality by Design, Design Space and Process Control Strategies in the course of industrial process design, validation and control.
Providing technical coaching, training and guidance to junior process engineers/scientists on drug product and buffer formulation related subject matter.
Leading tactical responses to process deviations, delivering technical solutions and communicating outcomes to site management.
Promote innovation to keep up to date with the latest regulatory expectations and industry trends.
Qualification
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Required
Bachelors in Basic Sciences, Pharmacy, Chemical Engineering or Mechanical Engineering required.
10 years of experience with drug substance, buffers, and / or drug product development and validation processes.
Knowledge of the design, operation and peripheral processes associated with formulation activities.
Preferred
Masters in Basic Sciences, Pharmacy, Chemical Engineering or Mechanical Engineering.
Strong technical writing skills.
Attitude of collaboration.
Ability to coach junior staff members.
eDoc, SAP, Track wise proficiency.
Benefits
High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave
Company
Sanofi
Sanofi is a healthcare company that provides treatments and the protection of life-saving vaccines.
10001+ employees
H1B Sponsorship
Sanofi has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (30)
2022 (95)
2021 (44)
2020 (45)
Funding
Current Stage
Public CompanyTotal Funding
$639.02MKey Investors
Blackstone Life SciencesEvotec
2022-03-15Post Ipo Equity· $329.02M
2019-01-02IPO
2014-12-02Post Ipo Equity· $310M
Leadership Team
Paul Hudson
Chief Executive Officer
Francois-Xavier Roger
Chief Financial Officer
Recent News
2024-12-25
2024-12-24
2024-12-24
Company data provided by crunchbase
