Area Lead Downstream Processing

Area Lead Downstream Processing (DSP)

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

Reporting to the Manufacturing Director the Downstream (DSP) Area Lead will play a pivotal role in establishing the Manufacturing Department initially during start-up by supporting operational readiness and providing operations input to ensure the facility design meets end user requirements and latterly post start-up by leading the manufacturing team to consistently deliver on specific Key Performance Indicators (KPIs). The DSP Area Lead will work closely with the MSAT (Material Science & Technology) teams to ensure the effective and efficient tech transfer of products and processes. The lead will work closely with QA QC and SCM teams to ensure compliant manufacturing processes and will collaborate with PM to meet the client demands.

Department Description

As Area Lead Downstream 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 Manufacturing Director.

Teil IV Berufliche Verantwortung / Part IV Job Responsibilities

• Lead a team of Shift Leaders to execute routine manufacturing activities in the commercial scale manufacturing of therapeutic proteins in a mammalian cell culture facility.
• Supervise daily DSP manufacturing activities and ensure production timelines are met.
• Schedule and/or deliver training to manufacturing personnel to ensure staff can perform manufacturing operations safely and compliantly.
• Communicate operational status regularly to senior management as required at the appropriate level of detail.
• Ensure equipment operates in a compliant manner and that all activities are conducted to meet GMP regulations with an RTF approach site and corporate quality standards and any additional regulatory requirements as required.
• Collaborate with MSAT groups on technical transfer and process validation
• Contribute to continual improvement of all manufacturing documentation (SOPs MBRs OJTs) to ensure they are current accurate and clear. 8. Support on visits audits of clients and authorities as DSP representative.

Teil III Mindestanforderungen an die Stelle / Part III Minimum Requirements

Bildungshintergrund und Erfahrung / Education Background and Experience

Qualifications:

• BSc MSc or PhD in Chemical Engineering Bioscience or Biotechnology. Masters level qualification would be advantageous with several years of working experience (at least 5 years) in the biotech or biopharma industry.

Besondere Kenntnisse / Special Knowledge

• 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.

• Fluent in English; German is preferred.
• A strong background in large-scale chromatography intermediate depth filtration ultrafiltration/diafiltration and viral inactivation and removal process steps and technologies. The individual needs to have good understanding in DQ FAT SAT IQ OQ & PQ (commissioning and qualification).

• Experience in CIP SIP clean room and water system (Purified Water pure steam and WFI) and process automation.
• A strong background in Media/Buffer preparation stainless steel tanks systems process automation (ABB DeltaV) and single use mixer technology.

Teil V Stellvertreter / Part V Deputy

The employee is the deputy of the position Head of Manufacturing for the following responsibility.

Delegate for signing and approving corresponding Manufacturing Documentation like SOP Batch Records etc. Verification that all GMP regulations will be followed within the Manufacturing.

The deputy of the employee is the DSP Shift Lead for the following responsibilities.

Technical supervision of regular production tasks within the department DSP. Verification that all GMP regulations will be followed within the DSP shift

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.