Vice President of Manufacturing
il y a 1 mois
The primary focus of this job is to lead and guide the late-stage clinical and commercial biologics manufacturing operations (Cell Culture, Purification, and Support Services) at our client's state-of-the-art facility located in Toulouse, France. This position will partner with MSAT, Quality Assurance, Facilities and Engineering, PMO, OE, and EH&S functions to ensure plant readiness and ongoing operational success.
The initial job duties will include recruiting and building the manufacturing organization, while leading operational readiness activities to support commercial GMP manufacturing. Additionally, the Head of Manufacturing Operations will oversee all GMP manufacturing operations, ensuring the manufacturing plant is commercially compliant, inspection ready, and licensable by the US FDA and EMA health authorities.
Job Responsibilities:
- Manage plant performance, ensuring operational excellence (OE)
- Establish the hiring strategy and implement high-performing team tactics to accelerate new technology platform implementation, focusing on the manufacture of first-in-class therapeutics.
- Establish and maintain platform approaches for standardized work; partner with Quality to establish GMP and OE training programs.
- Establish and model a culture of compliance.
- Review and approve GMP-controlled documentation, ensuring that it meets technical and regulatory requirements.
- Ensure the successful execution of advanced biologics manufacturing technologies.
- Troubleshoot and/or provide technical expertise to perform, lead, and close investigations.
- Implement and/or maintain cGMP compliant systems.
- Provide support for regulatory and site inspections.
- Develop a culture of compliance, continuous improvement, and safety.
- Incorporate and expand sustainability into manufacturing operations.
- Build and develop staff for future roles and career progression; ensure a culture of safety.
Additional Requirements:
- Extensive experience in late-stage/commercial biologics drug substance manufacturing.
- Technical mastery of cell culture and purification operations at commercial scale.
- Proven knowledge of cGMP requirements to ensure compliance.
- Advanced skills in the operation of single-use technologies, including cell culture, purification, and drug substance filling operations.
- Experience in commissioning, qualification, and validation, including risk assessments (SIA and CIA), user requirements, design qualification, installation qualification, operational qualification, performance qualification, and validation summary reports.
- Experienced risk assessment facilitator, including single point of failure (SPOF) and failure modes & effects (FMEA).
- Strong understanding of process automation (e.g., DeltaV) and validated BAS systems.
- Experienced in the use of electronic systems such as QMS, LIMS, MES/EBR, CMMS, and ERP systems.
To find out more about this opportunity reach out to me at Vincent.mackay@hartmannyoung.com
-
Sr Validation Engineer
il y a 7 jours
Toulouse, Haute-Garonne, France Just - Evotec Biologics Temps pleinValidation Engineer - Digital Systems - Toulouse, FranceJust is seeking a highly motivated Senior Digital Systems Validation Engineer that desires a significant opportunity to improve worldwide access to biotherapeutics. The primary focus of this role is to support Computerized System Validation (CSV) start up activities including Computer Systems of...
-
Toulouse, Haute-Garonne, France Quest Global Temps pleinAbout Quest Global:Quest Global is an organization at the forefront of innovation and one of the world’s fastest growing engineering services firms with deep domain knowledge and recognized expertise in the top OEMs across seven industries. We are a twenty-five-year-old company on a journey to becoming a centenary one, driven by aspiration, hunger and...
-
Senior Consultant_ SAP HANA
Il y a 2 mois
Toulouse, Haute-Garonne, France Infosys Temps pleinTechnology – SAP HANALocation – Toulouse, FranceBusiness Unit – Data and AnalyticsCompensation – Competitive (including bonus)The opportunityAre you someone who wants to collaborate with some of the best talent in the industry? Create innovative and high quality solutions to meet client’s business needs? If you are interested in being part of a...
-
Senior Consultant
il y a 4 semaines
Toulouse, Haute-Garonne, France Infosys Temps pleinTechnology – Python/Palantir FoundryLocation –Toulouse,FranceBusiness Unit – Data and AnalyticsThe opportunityAre you someone who wants to collaborate with some of the best talent in the industry? Create innovative and high quality solutions to meet client’s business needs? If you are interested in being part of a learning culture, where teamwork and...
-
Senior Consultant_ SAP BW HANA
il y a 1 semaine
Toulouse, Haute-Garonne, France Infosys Limited Digital Temps pleinJob details Country FranceState / Region / Province Toulouse Cedex 06Work Location ToulouseDomain DeliveryInterest Group Infosys LimitedSkills Technology|SAP Technical|SAP BW on HANACompany ITL FranceRequisition ID 117161BRJob description Technology - SAP BW-HANALocation - FranceBusiness Unit - Data and AnalyticsCompensation - Competitive (including...
-
Senior Consultant_ SAP HANA_ FR
il y a 1 semaine
Toulouse, Haute-Garonne, France Infosys Limited Digital Temps pleinJob details Country FranceState / Region / Province Toulouse Cedex 06Work Location ToulouseDomain DeliveryInterest Group Infosys LimitedSkills Technology|SAP Technical|SAP HANA XS / Native HANACompany ITL FranceRequisition ID 117164BRJob description Technology - SAP HANALocation - FranceBusiness Unit - Data and AnalyticsCompensation - Competitive (including...
-
Storage/Backup Consultant
il y a 1 semaine
Toulouse, Haute-Garonne, France Glocomms Temps pleinStorage/ Backup Consultant Location: Toulouse Working Arrangement: Hybrid Project Length: 3 year project Industry: Aerospace & DefenseMUST BE ENGLISH AND FRENCH SPEAKINGAbout the Company: A global leader in aerospace, defense, and security, this company specializes in designing, manufacturing, and maintaining high-technology systems. With a strong focus on...
-
Storage Backup Administrator
il y a 1 semaine
Toulouse, Haute-Garonne, France Glocomms Temps pleinJob Title: Storage/ Backup Administrator Location: Toulouse Working Arrangement: Hybrid Project Length: 3 year project Industry: Aerospace & DefenseAbout the Company:A global leader in aerospace, defense, and security, this company specializes in designing, manufacturing, and maintaining high-technology systems. With a strong focus on innovation, it provides...
-
Network Security Engineer
il y a 1 semaine
Toulouse, Haute-Garonne, France Glocomms Temps pleinJob Title: Network Security Build EngineerLocation: ToulouseWorking Arrangement: HybridProject Length: 3 year projectIndustry: Aerospace & DefenseAbout the Company:A global leader in aerospace, defense, and security, this company specializes in designing, manufacturing, and maintaining high-technology systems. With a strong focus on innovation, it provides...
-
Sr Software Field Applications Engineer
il y a 4 semaines
Toulouse, Haute-Garonne, France Qorvo, Inc. Temps pleinQorvo (Nasdaq: QRVO) supplies innovative semiconductor solutions that make a better world possible. We combine product and technology leadership, systems-level expertise and global manufacturing scale to quickly solve our customers' most complex technical challenges. Qorvo serves diverse high-growth segments of large global markets, including consumer...
-
SW Application Engineer
il y a 4 semaines
Toulouse, Haute-Garonne, France Qorvo, Inc. Temps pleinQorvo (Nasdaq: QRVO) supplies innovative semiconductor solutions that make a better world possible. We combine product and technology leadership, systems-level expertise and global manufacturing scale to quickly solve our customers' most complex technical challenges. Qorvo serves diverse high-growth segments of large global markets, including consumer...
-
Network Security Engineer
il y a 1 semaine
Toulouse, Haute-Garonne, France Glocomms Temps pleinJob Title: Network Security Build EngineerLocation: ToulouseWorking Arrangement: Hybrid 3 day onsite Project Length: 3 year projectIndustry: Aerospace & DefenseAbout the Company:A global leader in aerospace, defense, and security, this company specializes in designing,manufacturing, and maintaining high-technology systems. With a strong focus on innovation,...
-
Senior Vice President of Biologics Manufacturing
il y a 2 semaines
Toulouse, Occitanie, France Evotec WD Temps pleinSenior Vice President of Biologics Manufacturing - all genders Location: Toulouse Time Type: Full time Job Requisition ID: JOB ID-10797 The primary responsibility of this role is to oversee and direct the advanced stages of clinical and commercial biologics production operations (including Cell Culture, Purification, and Support Services) at Evotec...
-
Senior Vice President of Biologics Manufacturing
il y a 2 semaines
Toulouse, Occitanie, France Evote Temps pleinSenior Vice President of Biologics Manufacturing - all genders The primary objective of this role is to oversee and direct the advanced clinical and commercial biologics production operations (Cell Culture, Purification, and Support Services) at Evotec's cutting-edge facility. This position will collaborate with MSAT, Quality Assurance, Facilities and...
-
Vice President of Operations, Biologics Manufacturing
il y a 2 semaines
Toulouse, Occitanie, France Evotec WD Temps pleinVice President of Operations, Biologics Manufacturing Role Overview: The Vice President of Operations will be responsible for overseeing the advanced clinical and commercial biologics production processes at Evotec WD's cutting-edge facility. This leadership position will collaborate closely with various departments including Global MSAT, Quality...
-
Senior Vice President of Operations, Biologics Manufacturing
il y a 2 semaines
Toulouse, Occitanie, France Evote Temps pleinSenior Vice President of Operations, Biologics Manufacturing The main objective of this position is to oversee and direct the advanced clinical and commercial biologics production processes (Cell Culture, Purification, and Support Services) at Evote's cutting-edge facility. This role will collaborate with Global MSAT, Quality Assurance, Facilities &...
-
Vice President of Manufacturing
il y a 2 semaines
Toulouse, France Hartmann Young Temps pleinThe primary focus of this job is to lead and guide the late-stage clinical and commercial biologics manufacturing operations (Cell Culture, Purification, and Support Services) at our client's state-of-the-art facility located in Toulouse, France. This position will partner with MSAT, Quality Assurance, Facilities and Engineering, PMO, OE, and EH&S functions...
-
Vice President of Manufacturing
il y a 2 semaines
Toulouse, France Hartmann Young Temps pleinThe primary focus of this job is to lead and guide the late-stage clinical and commercial biologics manufacturing operations (Cell Culture, Purification, and Support Services) at our client's state-of-the-art facility located in Toulouse, France. This position will partner with MSAT, Quality Assurance, Facilities and Engineering, PMO, OE, and EH&S...
-
Vice President of Manufacturing
il y a 2 semaines
Toulouse, France Hartmann Young Temps pleinThe primary focus of this job is to lead and guide the late-stage clinical and commercial biologics manufacturing operations (Cell Culture, Purification, and Support Services) at our client's state-of-the-art facility located in Toulouse, France. This position will partner with MSAT, Quality Assurance, Facilities and Engineering, PMO, OE, and EH&S functions...
-
Senior Vice President of Biologics Manufacturing
il y a 2 semaines
Toulouse, Occitanie, France Evote Temps pleinPosition Overview: The main responsibility of this role is to oversee and direct the advanced stages of clinical and commercial biologics manufacturing operations, including Cell Culture, Purification, and Support Services. Key Responsibilities: Collaborate with various departments such as MSAT, Quality Assurance, Facilities and Engineering, PMO, OE, and...
-
Senior Vice President of Biologics Operations
il y a 2 semaines
Toulouse, Occitanie, France Hartmann Young Temps pleinPosition Overview:The primary responsibility of this role is to oversee and direct the advanced-stage clinical and commercial biologics production processes (including Cell Culture, Purification, and Support Services) at Hartmann Young's cutting-edge facility. This position will collaborate with various departments such as MSAT, Quality Assurance, Facilities...
-
Senior Manufacturing Technician
il y a 2 semaines
Toulouse, Occitanie, France Just Evotec Biologics EU Temps pleinManufacturing Associates III play a crucial role in executing process protocols, overseeing machinery and workflows, and performing essential tasks such as sampling and routine upkeep of laboratory instruments to support downstream production activities. The individual is expected to adhere to and follow established protocols for safety standards, cGMP...
-
Senior Manufacturing Technician
il y a 2 semaines
Toulouse, Occitanie, France Just Evotec Biologics EU Temps pleinManufacturing Associate III Job Overview At Just Evotec Biologics EU, we are seeking a dedicated **Manufacturing Associate III** to play a crucial role in our clinical and commercial production processes. This position is essential for ensuring adherence to **current Good Manufacturing Practices (cGMP)** while executing various manufacturing tasks. The...
-
Advanced Manufacturing Operator
il y a 2 semaines
Toulouse, Occitanie, France Just Evotec Biologics EU Temps pleinManufacturing Associate III Job Overview This role at Just Evotec Biologics EU encompasses the proficient execution of both clinical and commercial production activities while adhering to current Good Manufacturing Practices (cGMP). Manufacturing Associates III are tasked with carrying out production processes, overseeing equipment functionality, and...
-
Digital Transformation Leader
il y a 7 jours
Toulouse, Occitanie, France Just Evotec Biologics EU Temps pleinAbout Just – Evotec Biologics Just – Evotec Biologics, wholly-owned by Evotec SE, is a leading platform company that integrates the design, engineering, development, and manufacture of biologics. With deep expertise in protein, process, and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access...
-
Manufacturing Associate III
Il y a 3 mois
Toulouse, France Just Evotec Biologics EU Temps pleinManufacturing Associates III are expected to execute process recipes, monitor equipment and processes, perform basic tasks, including sampling, and routine maintenance of lab equipment in support of downstream manufacturing operations. The staff member is expected to comply and follow written procedures for safety requirements, cGMP Practices, Standard...
-
Business Consultant for Manufacturing Systems
il y a 2 semaines
Toulouse, Occitanie, France Expleo Group Temps pleinExpleo Group stands as a prominent authority in engineering, technology, and consultancy, aiding esteemed organizations in their quest for innovation to enhance their success. With a legacy spanning over four decades in the development of intricate products, refinement of production methodologies, and enhancement of information systems efficiency, we are in...
-
Manufacturing Associate III – Cell Culture
Il y a 3 mois
Toulouse, France Just Evotec Biologics EU Temps pleinThe focus of this job is to perform the successful execution of clinical and commercial manufacturing operations while ensuring cGMP compliance. This position is responsible for performing manufacturing operations and requires significant on-the-floor presence, as well as technical subject matter expertise in operations. Manufacturing Associates III are...
-
Director of Digital Systems
il y a 2 semaines
Toulouse, Occitanie, France Evotec WD Temps pleinDirector of Digital Systems (all genders) Evotec WD is in search of a Digital visionary who will establish the Digital team, culture, and frameworks necessary to develop and enhance a premier digitally-enabled platform for the advancement and production of sophisticated biopharmaceutical products. This position demands a collaborative leader adept at...
-
Senior Solutions Architect
il y a 2 semaines
Toulouse, Occitanie, France AWS EMEA SARL (France Branch) Temps pleinJoin Our Innovative TeamImagine being part of a group where your insights can transform the future of the Manufacturing and Aerospace sectors. At AWS, you will collaborate with a diverse and talented team, leveraging advanced technologies to assist our clients in expediting their digital evolution.Your RoleAs a Solutions Architect, you will support prominent...
-
Technical Architect
il y a 2 semaines
Toulouse, Occitanie, France AWS EMEA SARL (France Branch) Temps pleinJoin Our TeamBe part of a visionary group that is set to transform the Manufacturing and Aerospace sectors. At AWS, you will collaborate with a diverse and skilled team, leveraging state-of-the-art technologies to facilitate our clients' digital evolution.Your RoleAs a Solutions Architect, you will engage with major manufacturing enterprises, crafting...
-
Head of Strategic Partnerships
il y a 2 semaines
Toulouse, Occitanie, France Evote Temps pleinHead of Strategic Partnerships Company Overview Evotec is a leading life sciences organization with a distinctive business model dedicated to providing highly effective new therapeutics to patients. The company utilizes its multimodal platform and extensive drug discovery expertise across various therapeutic domains, referred to as the "Data-driven R&D...