MFG Shift Lead Up Stream

MFG Shift Lead (UPS) Upstream

Reporting to the Upstream Area Lead, the Upstream 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 (KPI's).

Department Description

As MFG Shift Lead Upstream, 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 Upstream Area Lead.  

Key responsibilities will include:

• 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 USP 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 USP 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 USP 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 time frames.
• Responsible for the development and coaching of employees to ensure the proper level of performance and behaviour.
• 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 USP problems and deal with a variety of situations where critical problem solving is required.

Person Specification

Qualifications:

• Apprenticeship as Chemikant/Pharmakant or CTA/BTA with several years of working experience (at least 3 years) in the biotech or biopharma industry is advantageous preferable with further qualification as "Techniker" or "Meister". In 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 3 years)

Technical Competencies/Experience Required:

• 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 Upstream processing.
• Experience in the large-scale fermentation (fed batch and perfusion) of mammalian cell cultures, centrifuge and depth filtration harvest 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.

Behavioural Competencies

• 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 if required 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

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WuXi Biologics is an equal opportunities employer.