Manager Manufacturing - Purification

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Job Description

The Purification Manager is responsible for managing the manufacturing operations of his Purification Line (depending on the Purification Line, products can be amongst others: Glassia, Gammagard Liquid/Kiovig, Gammagard S/D, Cuvitru) in line with the Takeda Business Strategy Plan:

• Guarantee the output of Purification Line assuring the respect of the quality, production schedule and standard cost;

• Ensure strict compliance with cGMP, 21 CFR’s, Corporate, Divisional and regulatory requirements;

• Promote individuals in technical, organizational and management fields

• Manage a multi-shift production team, ensuring resource availability, and developing staff, fostering a culture of continuous improvement

• Strongly support the Takeda culture in Ethics, Compliance and EHS.

The Purification Manager also drives the deployment of the Continuous Improvement (CI) culture across his field of responsibilities; he is also responsible for the good execution of the project portfolio on his Manufacturing Line.

The Purification Manager ensures production commitments are met, implement lean manufacturing processes, report KPI’s (Quality, Supply Chain, EHS), facilitates process improvements and fosters team development and flexibility.

• Management of the manufacturing operations related the purification of target products in order to meet the weekly and monthly commitments.

• Analyze the performance of the purification line using dedicated tools, manage and report Key Performance Indicators (KPI’s).

• Jointly with Human Resources, manage the multi-shift team, hire new employees, perform active coaching and mentoring of team members, manage individual cases, conduct evaluations and set goals for the team members.

• Support the root cause investigation related to process deviations and implement corrective and preventive actions in a timely manner.

• Ensure the safety of the manufacturing Team by supporting and participating in EHS initiatives and by on-the-floor presence through Gemba.

• Proactively interface with production Team, internal suppliers, and internal customers to identify and implement areas of continuous improvement (CI). Lead, coach and oversight CI initiatives under his scope of responsibility.

• Support internal and external regulatory inspections, including oral defense of dossiers in inspection room.

• Effectively coordinate with facilities and maintenance staff to ensure production equipment is functional and available for production.

• Ensure the strict application of cGMPs, 21 CFRs, and Corporate procedures in the manufacturing team under his responsibility.

• Lead initiatives related to the improvement of the existing management Control systems through A3, Leader Standard Work and Tier meeting.

• Batchelor in Biochemistry/Science/Bio-Engineering or higher degree (Master/Ph.D).

• At least 5 years in a position of Manufacturing/Manufacturing Sciences/Process Engineering.

• Management skills : leadership, assertivity, stress resistant, flexibility, integrity, communication, excellent manager for himself and for the team

• Outstanding communication skills, be able to interact with manufacturing teams, internal and external customers and regulatory bodies.

• Capacity to federate the services interacting with Manufacturing (i.e. Quality, Supply Chain) in order to achieve manufacturing or site objectives.

• Mastering DMAIC methodology and associated statistical tools.

• Fluent in French and English (both oral and written).

• Computer skills : Microsoft Office Programs (Word, Excel, Powerpoint), JDE, Minitab, SQ LIMs, Critical Farm_Citrix (OSIPI).

• Experience with Lean Six Sigma tools and Project Management skills

• Experience with troubleshooting and problem solving with process and equipment

• Experience with automated process equipment and control

• Broad technical knowledge in Purification and more specifically in production capacity modelling

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

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