Associate Global Project Manager

(Global Biologics Manufacturing Science and Technology Drug Product Europe)

We are pleased to present this opportunity to you on behalf of our client. They are one of the world's most reputable, Pharmaceutical institutions. You as the Associate Global Project Manager could get unique experiences and have good exposure in the business.

THE INCUMBENT WILL:

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provide technical expertise for commercial aseptic drug product manufacturing at contract manufacturing organizations (CMOs)
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ensure technical leadership for commercial process transfers to CMOs
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define and guide commercial drug product production network alignment activities
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provide technical support to the Technical Product Management organization

TASKS

Lead or participate in cross-functional and/or cross-site technical projects and teams to provide technical expertise to commercial aseptic drug product manufacturing activities at CMOs and/or process transfers to CMOs. This includes:

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technical inputs into the CMO strategy
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technical feasibility and expertise for process decisions
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technical aspects for health authority interactions
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definition of process validation strategy
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technical leadership of risk management activities

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Serve as a point of contact to the External Manufacturing organization to represent Global Biologics Manufacturing Science and Technology on multiple projects as a core member of the CMO Joint Management Team.
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Write and/or review regulatory submissions, validation reports, quality investigation reports and change control assessment for technical content.
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Identify, develop and communicate manufacturing best practices and harmonized business processes to the commercial Biologic drug product production network in order to facilitate manufacturing process consistency
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Participate in cross-site and cross-functional teams responsible for the technical oversight of commercial aseptic drug product manufacture and process improvements, developing global standards, troubleshooting issues, analysis of cross-site process performance data and implementation of quality standards.
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Support the Technical Product Management organization in serving as a member on the product teams.
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Collaborate closely with the CMO site management, quality site management, quality product leaders, drug product technical leaders and other stakeholders in pharmaceutical development and commercial aseptic drug product manufacturing.
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Advanced degree in life sciences or engineering
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5 - 7 years of professional experience in pharmaceutical industry, including 3 years in aseptic drug product formulation, process development or manufacturing
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Technical experience in aseptic manufacturing of commercial
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biological drug products
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Skills as a project leader
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Effective communicator; solid written, oral and interpersonal communications and presentation skills
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Ability to collaborate and negotiate solutions in fast paced Matrix environment interacting at various functional levels
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Strong quality orientation with good knowledge of cGMPS's, regulatory guidelines and validation practices
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Strong analytical and creative problem solving skills to address a broad range of complex problems
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Ability to make sound decisions by considering degree of impact on individual business units
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Flexibility in work hours and travel (approx.. 20%) to meet business objectivesDivision Pharma, PTBS-S, Kaiseraugst 2/3
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Very good English-language speaking and written skills are required
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Skilled with standard office applications and systems typically used in the bio-pharmaceutical industry (eg TrackWise)

This is a great opportunity to grow with an International and reputable organization that offers an exciting working environment. If you fit the specification, please apply!

Good to know you !