Manufacturing Operations Support Manager
il y a 1 mois
Manager, Manufacturing Operations - Manufacturing Support (all genders)
Just-Evotec Biologics is seeking a highly motivated Manager, Manufacturing Operations - Manufacturing Support to lead the manufacturing support manufacturing operations team at the industry-leading J.POD Toulouse biotherapeutics manufacturing facility. You will report to the Head of Manufacturing Operations and will be responsible to hire, train, develop and lead the manufacturing support operations team to support the operations of multiple commercial-scale cGMP manufacturing trains employing the innovative Just-Evotec continuous processing platform in 24/7 operations.
Responsibilities
Hire, train, develop and lead the manufacturing support manufacturing operations team, consisting of manufacturing support manufacturing shift supervisors, manufacturing operators, and manufacturing specialists. Manufacturing support operations include: multi-column protein A capture chromatography, viral inactivation, depth filtration, polishing chromatography, viral filtration, tangential flow filtration, drug substance fill.
Prepare and supervise the manufacturing support operations team to support the concurrent operation of multiple commercial-scale cGMP manufacturing trains employing the innovative Just-Evotec continuous processing platform in 24/7 operations.
Apply your experience in managing cGMP manufacturing operations and your expert technical knowledge of manufacturing support operations to build a high performing team that consistently meets/exceeds goals for safety, quality, and production performance and is empowered by a culture of operational excellence. Provide significant on-the-floor presence to observe and coach your team.
Collaborate with teammates within the manufacturing operations team, with other functional teams across J.POD Toulouse and with colleagues at other J.POD sites to contribute to achieving Just-Evotec’s goals for safety, quality and production; and to building/sustaining a culture of operational excellence.
Develop and implement plans for Operational Readiness (OR) and New Product Introduction (NPI) to ensure the manufacturing support operations team is ready to support the on-time initial startup of plant operations and the introduction of new products to J.POD Toulouse.
Ensure the manufacturing support operations team maintains full compliance with cGMP training and procedural requirements.
Ensure records related to manufacturing support operations (e.g. batch records, procedures, deviations, CAPAs, material consumption, etc.) are generated, approved, and retained in accordance with the Quality Management System.
Support regulatory, client and internal audits, including presenting records to auditors, when required. Ensure records, equipment and materials related to manufacturing support operations are audit-ready at all times.
Establish and implement escalation thresholds and response procedures to rapidly report, diagnose, contain, and resolve issues pertaining to safety, quality, and production as they arise. Be available for 24/7 recall to respond to escalated issues as they arise.
Supervise (or lead, when appropriate) investigations and troubleshooting efforts, ensuring timely resolution of technical issues while maintaining compliance.
Oversee the development and implementation of individual development plans for members of the manufacturing support operations team to ensure that team members have the fundamental skills and knowledge needed to perform their duties and to advance in their careers.
Provide input to planning processes for hiring and budget (OPEX and CAPEX)
When needed, support site management at Work Council meetings on matters pertaining to working conditions for the manufacturing support operations team.
Requirements:
Masters degree in Bioprocessing, Biopharmaceutical Engineering, or related program with 10+ years of experience in manufacturing support processing (DSP) for a cell culture process using mammalian cells to produce monoclonal antibodies (mAbs), including a minimum of 3 years in a management role for manufacturing support for a mammalian cell culture process.
Extensive knowledge and experience applying US FDA CFRs and European EMA, ICH guidelines and other applicable regulations and industry guidance as they relate to cGMP manufacturing of biotherapeutic drug substance.
Technical mastery of cell culture, purification, and solution preparation operations using single-use manufacturing technologies
Demonstrated success in building and leading high-performing teams, leading organizational change, and influencing internal and external stakeholders.
Demonstrated expertise in leading teams in the investigation and resolution of complex technical and organizational problems.
Excellent interpersonal, teambuilding, and collaboration skills.
Excellent verbal and written communication skills in French and English; ability to interface with all levels of the organization.
Additional Preferred Qualifications:
Experience in the following manufacturing technologies/operations
Single-use technology (including Single Use Mixers and Totes)
Weigh and dispense operations
Buffer solution preparation
Media solution preparation
Viral filtration
Chromatography column packing and performance analysis
Large-format (1m +) parts washer and autoclave operations.
Management of Clean Room cleaning operations.
Enterprise Resource Management (ERP) systems (esp. SAP)
Process Control Systems (PCS) (esp. DeltaV)
Manufacturing Execution Systems (MES) (esp. PasX)
Data Historian System (esp. Aveva PI)
Experience in manufacturing plant startup.
Experience in new product introduction
Experience in audits and inspections by health authorities, clients and other external auditors as a presenter or audit support staff.
Experience in leading risk assessment and risk management for pharmaceutical products and processes. Experience in applying principles of Quality by Design.
Experience in developing submission packages for pharmaceutical product registration.
FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.
ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.
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