Easter Seals Jobs

Primary Container - LCM Lead - 2406188499W

Description

The incumbent holds a strategic role within global MSAT PCD and will partner with multiple internal and external partners to manage all aspects of life cycle associated to Primary Container within the Large Molecule Drug Product platform. The Primary Container LCM lead will supervise multiple contractors and manages a portfolio of change controls, investigational support activities, material science aspects, HA support and remediation activities.

PRINCIPAL RESPONSIBILITIES:

• Single point of contact for all primary containers related lifecycle management aspects

• Leads and collaborates with a team of external contractors to structure, develop and execute

• Manages an entire LCM portfolio of change controls, works closely with global functions (DOTS, SQ, PES, DDS) and internal partners (operations, MSAT, QC/QA, DML)

• Lead projects as necessary to address issues with customer satisfaction, quality, manufacturing improvements and cost reductions, lead design change controls for primary containers

• Perform technical assessments on combination product change controls and provides audit support where necessary.

Qualifications

Education:

• Minimum of a Bachelor's/University or equivalent degree required; focused degree in life science, engineering, material, analytical or pharmaceutical sciences or equivalent is preferred.

Experience and Skills:

Required:

• Minimum 4 years of relevant work experience

• Primary Container, Device Assembly & Packaging knowledge

• Relevant experience in Operations, Engineering, Quality Assurance, MSAT, Planning, or Business Excellence

• Excellent verbal and written communication and presentation skills, with the ability to influence without direct authority, across functional teams and different organizational levels

• Curiosity and drive to deep dive into scientific questions, self-starter, and entrepreneurial working style.

• Excellent organizational, planning and presentation skills and strong interpersonal, verbal, and written communications capabilities. Demonstrates an effective collaboration mind-set.

Preferred:

• Experience in primary packaging components (Syringe, vials, cartridge)

• Knowledge & expertise in applying Combination Products cGMP regulations

• Aseptic drug product manufacturing experience is beneficial for this role

• Lean / Six Sigma / Process Excellence methodology experience, training, and/or certification

• Experience leading change in a Pharmaceutical and/or other cGMP manufacturing environment.

Other:

• Requires fluency in English and German (written and oral)

• May require up to 5% domestic and international travel

• Requires the ability, through our flexible work policy, to work on-site a minimum of three days each week, with the option for two remote workdays each week

Primary Location Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen

Organization Cilag AG (8562)

Job Function Packaging Design Engineering

Req ID: 2406188499W