Associate Global Project Manager in Global Biologics Manufacturing Sci

Associate Global Project Manager in Global Biologics Manufacturing Science and Technology

Global Biologics Manufacturing Science and Technology is a function of Global Technical Development in Pharma Global Technical Operations. Its core responsibility include providing technical expertise for commercial aseptic drug product manufacturing at contract manufacturing organizations (CMOs), ensuring technical leadership for commercial process transfers to CMOs, defining and guiding commercial production network alignment activities and providing technical support to the Technical Product Management organization.

The incumbent will:

provide technical expertise for commercial aseptic drug product manufacturing at contract manufacturing organizations (CMOs)

ensure technical leadership for commercial process transfers to CMOs

define and guide commercial drug product production network alignment activities

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:

technical inputs into the CMO strategy

technical feasibility and expertise for process decisions

technical aspects for health authority interactions

definition of process validation strategy

technical leadership of risk management activities

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.

Write and/or review regulatory submissions, validation reports, quality investigation reports and change control assessment for technical content

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

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

Support the Technical Product Management organization in serving as a member on the product teams

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

Qualification:

Advanced degree in life sciences or engineering

5 - 7 years of professional experience in pharmaceutical industry, including 3 years in aseptic drug product formulation, process development or manufacturing

Technical experience in aseptic manufacturing of commercial biological drug products

Skills as a project leader

Effective communicator; solid written, oral and interpersonal communications and presentation skills

Ability to collaborate and negotiate solutions in fast paced Matrix environment interacting at various functional levels

Strong quality orientation with good knowledge of cGMPs, regulatory guidelines and validation practices

Strong analytical and creative problem solving skills to address a broad range of complex problems Ability to make sound decisions by considering degree of impact on individual business units

Flexibility in work hours and travel (approx. 20%) to meet business objectives

Further Qualifications:

Very good English and German language speaking and written skills are required

Skilled with standard office applications and systems typically used in the biopharmaceutical industry

Whether this role is the right fit or you would like to see if there are others that do, our dedicated and expert team is looking forward to hearing from you.

Good to know you!