MFG Shift Lead Downstream (DSP)

Wuppertal - Germany

Monthly Salary: Not Disclosed

Posted on: 18 hours ago

Vacancies: 1 Vacancy

Job Summary

MFG Downstream Shift Lead (DSP)

Teil II Primäres Ziel der Stelle / Part II Primary Job Objective

The Downstream (DSP) Shift lead will play a pivotal role in establishing the Manufacturing Department during the production ramp-up start-up phase by leading the manufacturing team to consistently deliver on specific Key Performance Indicators (KPIs).

Department Description

As Downstream Shift lead you will be joining an organization where people of all backgrounds and experiences are respected and where we work together focused on changing lives. In this role you will report to the Downstream (DSP) Area Lead.

Teil IV Berufliche Verantwortung / Part IV Job Responsibilities

Oversees implementation of skills training and safety programs to ensure employees work in compliance with all company SOPs policies cGMPs and applicable safety and regulatory requirements.
The DSP Shift lead is responsible for commercial manufacturing operations. The position ensures the effective scheduling and utilization of facilities equipment and personnel in producing quality products meeting customer delivery requests and internal performance targets.
Provide floor leadership supervision and hands-on training for DSP Manufacturing personnel.
Optimize resources within assigned areas to ensure efficient compliant operations.
Participate in projects and activities which support company goal.
Supervise daily manufacturing activities in our DSP Department.
Draft and review GMP documents including but not limited to SOP/MBR/URS/FAT/SAT and review batch manufacturing records. Coordinate activities with other operational groups (quality facilities materials etc) to ensure schedule adherence.
Collaborate with Quality Assurance to address deviations perform investigations support change controls and implement corrective/preventive actions.
Ensure compliance for all manufacturing related activities are completed accurately and within allotted timeframes.
Responsible for the development and coaching of employees to ensure the proper level of performance and behavior.
Assist performance appraisals and organizational audits to assess the current and future needs of the organization and implement plans to assure future needs are addressed.
Ability to solve DSP problems and deal with a variety of situations where critical problem solving is required.

Teil III Mindestanforderungen an die Stelle / Part III Minimum Requirements

Bildungshintergrund und Erfahrung / Education Background and Experience

Qualifications:

Apprenticeship as Chemikant/Pharmakant or CTA/BTA with several years of working experience (at least 5 years) in the biotech or biopharma industry is advantageous preferable with further qualification as Techniker or addition a BSc or MSc in Biochemistry or Biotechnology with several years of working experience in Life Science Biotech or Biopharma Industry would be advantageous (at least 5 years)

Knowledge/Experience:

Ideally experienced in establishing a Manufacturing department and building a team in a greenfield context of similar size and scale.
More than 5 years in biopharmaceutical manufacturing with extensive experience in Downstream processing.
Experience in large-scale chromatography intermediate depth filtration ultrafiltration/diafiltration and viral inactivation and removal process steps and technologies.
Experience in dealing with FDA and/or EMA and CFDA and have a solid understanding of quality system in terms of deviation investigation CAPA and change control.
Must be quality focused with knowledge and understanding of cGMP quality systems and how they apply to manufacturing operations.
Excellent communication skills and good oral and written English.

Besondere Kenntnisse / Special Knowledge/Behaviours

A strong leader with the ability to adapt to daily challenges of a manufacturing work environment while maintaining positive and productive attitude and fostering this attitude among direct reports.
Excellent verbal and written communication and presentation skills.
Excellent interpersonal skills with the ability to work effectively with staff at all levels of the organisation.
Ability to work on own initiative and be proactive.
Results oriented with the ability to manage multiple priorities in a short period of time.
Excellent organisational and planning skills and strong attention to detail.

Onerous requirements

Must be willing to travel as required internationally to fulfil the responsibilities of the position

As we extend our global reach we need colleagues interested in change in challenge and in building a new future together. Reach beyond yourself and discover your true potential! Apply now!

Would you like to know more before you apply Please visit us at .
WuXi Biologics is an equal opportunities employer.

MFG Downstream Shift Lead (DSP)Teil II Primäres Ziel der Stelle / Part II Primary Job ObjectiveThe Downstream (DSP) Shift lead will play a pivotal role in establishing the Manufacturing Department during the production ramp-up start-up phase by leading the manufacturing team to consistently deliver ...

MFG Downstream Shift Lead (DSP)

Teil II Primäres Ziel der Stelle / Part II Primary Job Objective

Department Description

Teil IV Berufliche Verantwortung / Part IV Job Responsibilities

Oversees implementation of skills training and safety programs to ensure employees work in compliance with all company SOPs policies cGMPs and applicable safety and regulatory requirements.
The DSP Shift lead is responsible for commercial manufacturing operations. The position ensures the effective scheduling and utilization of facilities equipment and personnel in producing quality products meeting customer delivery requests and internal performance targets.
Provide floor leadership supervision and hands-on training for DSP Manufacturing personnel.
Optimize resources within assigned areas to ensure efficient compliant operations.
Participate in projects and activities which support company goal.
Supervise daily manufacturing activities in our DSP Department.
Draft and review GMP documents including but not limited to SOP/MBR/URS/FAT/SAT and review batch manufacturing records. Coordinate activities with other operational groups (quality facilities materials etc) to ensure schedule adherence.
Collaborate with Quality Assurance to address deviations perform investigations support change controls and implement corrective/preventive actions.
Ensure compliance for all manufacturing related activities are completed accurately and within allotted timeframes.
Responsible for the development and coaching of employees to ensure the proper level of performance and behavior.
Assist performance appraisals and organizational audits to assess the current and future needs of the organization and implement plans to assure future needs are addressed.
Ability to solve DSP problems and deal with a variety of situations where critical problem solving is required.

Teil III Mindestanforderungen an die Stelle / Part III Minimum Requirements

Bildungshintergrund und Erfahrung / Education Background and Experience

Qualifications:

Apprenticeship as Chemikant/Pharmakant or CTA/BTA with several years of working experience (at least 5 years) in the biotech or biopharma industry is advantageous preferable with further qualification as Techniker or addition a BSc or MSc in Biochemistry or Biotechnology with several years of working experience in Life Science Biotech or Biopharma Industry would be advantageous (at least 5 years)

Knowledge/Experience:

Ideally experienced in establishing a Manufacturing department and building a team in a greenfield context of similar size and scale.
More than 5 years in biopharmaceutical manufacturing with extensive experience in Downstream processing.
Experience in large-scale chromatography intermediate depth filtration ultrafiltration/diafiltration and viral inactivation and removal process steps and technologies.
Experience in dealing with FDA and/or EMA and CFDA and have a solid understanding of quality system in terms of deviation investigation CAPA and change control.
Must be quality focused with knowledge and understanding of cGMP quality systems and how they apply to manufacturing operations.
Excellent communication skills and good oral and written English.

Besondere Kenntnisse / Special Knowledge/Behaviours

A strong leader with the ability to adapt to daily challenges of a manufacturing work environment while maintaining positive and productive attitude and fostering this attitude among direct reports.
Excellent verbal and written communication and presentation skills.
Excellent interpersonal skills with the ability to work effectively with staff at all levels of the organisation.
Ability to work on own initiative and be proactive.
Results oriented with the ability to manage multiple priorities in a short period of time.
Excellent organisational and planning skills and strong attention to detail.

Onerous requirements

Must be willing to travel as required internationally to fulfil the responsibilities of the position

As we extend our global reach we need colleagues interested in change in challenge and in building a new future together. Reach beyond yourself and discover your true potential! Apply now!

Would you like to know more before you apply Please visit us at .
WuXi Biologics is an equal opportunities employer.

Key Skills

Arm
Python
Debugging
C/C++
5G
Signal Processing
Matlab
Fpga
Linux
Software Development
Assembly
4G/LTE

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About Company

WuXi Biologics

A leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing

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