Manager, New Materials Validation

Reference No. R2716304

Place Title: Supervisor, New Supplies Validation

Length: Mounted-Time period – Contract Finish Date: January 31, 2025

Division: B100 MTech

Location : Toronto, Ontario

Sanofi Vaccines

Sanofi’s world vaccines enterprise unit companions with the general public well being, medical and scientific communities to enhance entry to life-protecting vaccines and enhance vaccination protection, whereas striving to develop new and improved vaccines to reinforce well being and well-being.

At Sanofi, we chase the miracles of science to enhance individuals’s lives. We imagine our cutting-edge science and manufacturing, fueled by information and digital applied sciences, have the potential to remodel the observe of drugs, turning the unimaginable into doable for thousands and thousands of individuals.

Place Abstract:

The Supervisor, New Supplies Validation will report on to the B100 MTech Deputy Director, Course of Validation and LCM, with the next key accountabilities:

• Ship a powerful and complete validation program and bundle with give attention to new supplies qualification that features uncooked supplies, consumables, filters and single-use know-how

• Guarantee choice and implementation of applicable options for single-use know-how.

• Handle and supply technical management for the technique, planning and execution of validation actions.

• Handle actions associated to procurement of single-use know-how reminiscent of improvement of Consumer Requirement Specs and evaluation of vendor proposals.

Key Obligations:

Technical Course and Administration – 40%

• Handle the general technical program (consists of materials evaluation and qualification/validation) associated to uncooked supplies, consumables, filters, single-use know-how and extractables & leachables (E&L).

• Assess new know-how implementations, together with closed programs and single-use know-how (SUT).

• Evaluation/Approve vendor designs/proposals to make sure alignment with course of necessities and specs.

• Develop and help qualification program for single use inside a big capital mission.

• Lead analysis/suitability of use for SUT options (e.g. filters, tubing, connectors, containers, and so forth) for 5acP, Diphtheria and Tetanus processes.

• Drive and handle the E&L grasp plan and research to help new in-process supplies, drug substance containers, and so forth.

• Present technical danger assessments and hole evaluation.

• Assist preparation and evaluation of fabric specs and consumer requirement specs.

• Establish and consider materials dangers primarily based on technical and high quality standards.

• Establish and implement course of enhancements.

Transversal Experience and Administration – 30%

• Lead and liaise with Web site and World Procurement and Web site High quality for securing new supplies for the mission.

• Community with native and world specialists and course of specialists as obligatory, leveraging data/information the place doable.

• Work intently with Crucial Supplies Administration (CMM) groups and Heart of Experience (CoE) to make sure finest practices and harmonized method for danger administration, qualification, and implementation primarily based on strategic street maps.

• Actively take part and liaise with World Single Use Community and leverage finest practices.

Ship on Undertaking Execution and Qualification Phases – 30%

• Assist execution phases of the mission (validation, start-up, ramp-up) in coordination with Operations, Technical Providers, High quality and RA.

• Assist C&Q technique, planning and validation.

• Apply efficient and structured troubleshooting/root trigger evaluation methods for manufacturing issues as required, and potential enhancements in high quality.

• Oversee related qualification throughout engineering and consistency tons.

• Guarantee easy transition to routine operations following mission turnover, which incorporates related coaching on single-use programs.

• Help within the implementation of a producing schedule to fulfill the submit startup market demand along with Operations and different features as required.

• Help with the discussions and interactions with the regulatory businesses the place required.

HSE Requirement/Assertion:

• Supervises and screens compliance with employment and well being and security laws to make sure that workers work throughout the insurance policies, procedures and rules relevant to their work.

• Participates within the investigation of incidents and work-related sicknesses.

• Responds promptly to all well being and security considerations or incidents and completes the suitable documentation in a well timed method.

• Takes each cheap precaution to make sure the well being and security of employees.

• Ensures that protecting tools and clothes required is utilized by employees.

• Cooperates and assists the Joint Well being and Security Committee in finishing up its features.

• Advises employees of any potential or precise well being and security hazard of which they’re conscious.

Context of the job/Main challenges:

• Workplace environment- 20-30 hrs/ week

• Manufacturing/Laboratory setting: 10-20 hrs/week.

• Full gowning throughout manufacturing part (engineering and consistency batches).

• Some journey required in North America and Europe.

• Advanced mission group and phasing.

• Managing change and priorities inside a dynamic and shifting mission schedule.

Dimensions/Scope:

• Breadth of Duty: Toronto, Canada.

• Key Dimensions: Massive biopharmaceutical facility mission, with in depth scope and complexity in facility/ automation/course of design and qualification, course of enchancment implementation; efficient cross-functional interplay, communication and crew administration.

• Freedom to behave, stage of autonomy: interface with Manufacturing Expertise crew, mission crew and mission leaders.

Key Necessities:

• Minimal B.Eng., B.Sc. or equal; M.Sc. most popular.

• Minimal 5 years direct expertise in biotech pharma/biotech manufacturing, and high quality environments in a course of validation function.

• 5+ years demonstrated management in behavioral competencies and mission administration.

• Demonstrated understanding of present Good Manufacturing Practices, Well being and Security, prime quality requirements, trade requirements and their utility to the manufacturing course of.

• Technical expertise and specialist experience in course of validation, with give attention to new supplies and single use design and utility.

• Tools validation expertise is an asset.

• Experience in course of industrialization with sensible expertise in industrial manufacturing setting.

• Robust technical writing is important.

• Wonderful communication, written and transversal administration abilities.

• Good understanding of present regulatory necessities and doc preparation.

• Efficient in troubleshooting and root trigger.

Pursue Progress.

Uncover Extraordinary

Higher is on the market. Higher drugs, higher outcomes, higher science. However progress doesn’t occur with out individuals – individuals from totally different backgrounds, in numerous places, doing totally different roles, all united by one factor: a need to make miracles occur. So, let’s be these individuals.

Watch our ALL IN video and take a look at our Range, Fairness and Inclusion actions at sanofi.com!

Sanofi is an equal alternative employer dedicated to variety and inclusion. Our aim is to draw, develop and retain extremely proficient workers from various backgrounds, permitting us to learn from all kinds of experiences and views. We welcome and encourage purposes from all certified candidates. Lodging for individuals with disabilities required throughout the recruitment course of can be found upon request.

Thanks upfront on your curiosity.

Solely these candidates chosen for interviews might be contacted.

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At Sanofi variety and inclusion is foundational to how we function and embedded in our Core Values. We acknowledge to actually faucet into the richness variety brings we should lead with inclusion and have a office the place these variations can thrive and be leveraged to empower the lives of our colleagues, sufferers and prospects. We respect and rejoice the range of our individuals, their backgrounds and experiences and supply equal alternative for all.