Laboratory Manager – Device and Combination Development (all genders)

About AbbVie AbbVie's mission is to discover and deliver innovative
medicines and solutions that solve serious health issues today and
address the medical challenges of tomorrow. We strive to have a
remarkable impact on people's lives across several key therapeutic
areas including immunology, oncology and neuroscience – and products
and services in our Allergan Aesthetics portfolio. Job Description The
job that makes possibilities real in patients' lives. And yours. The
job that helps you get ahead in life. Moving mountains together.
Welcome to AbbVie! As part of an international company with 48,000
employees worldwide and around 3,000 employees in Germany, you will
have the opportunity of addressing some of tomorrow's unmet medical
needs in close collaboration with your colleagues. Are you passionate
about improving global health care? Do you want to contribute to
improving patients' quality of life through your expertise? In a
challenging work environment that offers opportunities of developing
and increasing your own skills? You've come to the right place! Moving
mountains together – as Laboratory Manager Device and Combination
Development (all genders) We are looking for a Senior Scientist II /
Principal Research Scientist I (all genders), Laboratory Manager
Engineering Testing & Analysis, to join our Device and Combination
Product Development team. Within Device and Combination Product
Development, the Senior Scientist II / Principal Research Scientist I,
Laboratory Manager Development & Design Verification Testing, is
responsible for leading Development, Testing and Design Verification
Testing activities. The Design Inputs are based on user, product and
stakeholder needs which are translated into product requirements and
result in completing feasibility assessments involving prototyping and
lab testing and ultimately supporting design and verification
activities that result in robust devices. These devices enable the
delivery of AbbVie’s innovative medicines targeted at
difficult-to-cure diseases with the goal of making a remarkable impact
on people’s lives. As a Laboratory Manager Development & Design
Verification Testing you would be part of a multi-disciplinary team of
professionals working at the intersection of engineering and
biopharmaceuticals. If you are a self-motivated & communicative person
who thrives on solving complex problems and are excited by the idea of
taking on the toughest health challenges, this opportunity might be
for you. Your tasks and responsibilities: Lead the Engineering Testing
& Laboratory team (ETAG) at AbbVie Ludwigshafen Device & Combination
Product Development. Planning, coordination and execution of
Engineering Confidence- and Design Verification Testing for
Parenteralia / Pharmaceutical Application Systems (Combination
Products) activities including functional performance testing of
Combination Products and other studies where functional performance
testing might be required. Proven leadership track record that
includes the ability to influence and negotiate internally and
externally as a part of global teams. Represents ETAG as single point
of contact for assigned projects in local and global teams.
Establishes and applies phase-appropriate development & testing
concepts for assigned projects in a resource-responsible manner.
Promotes harmonized development strategies across projects and sites.
Drive test method development incorporating relevant standards

requirements such as ISOs and/or Pharmacopeia and relevant AbbVie
internal and/or external interfaces (regarding method comparability,
applicable specifications, requirements for commercial process for
in-process controls and/or release tests). Validation of test methods
for performance testing of Combination Products. Method Transfers
and/or Co-Validation to relevant internal or external interfaces. Lead
Non-conformity Investigations / Issue Resolutions. Provide general
framework and guarantee documentation according to Good Manufacturing
Practices (GMP) and Design Control applicable standards. Support
compiling and verifying content for regulatory submission reports and
providing relevant data in time. Define and establish Design
Verification Processes. Exchange and align, where appropriate,
cross-functional. Lead through and participate in initiatives for
process improvements intra- and inter departmental. Guarantee GMP
compliant framework regarding infrastructure such as Standard
Operations Processes (SOPs) for the overall Quality System, training
requirements and Instrument Qualification. Close exchange with
different program leads and -interfaces at early- and late-stage
Design Control process steps. Member in global Design and Development
Teams and participation in Design Reviews as Design Verification
Subject Matter Expert. Representative within internal and authorities
inspections for the areas of responsibility. Demonstrate creative 'out
of the box' thinking to solve difficult technical problems and
champion new technologies to achieve project goals. Qualifications
Senior Scientist II

University degree in biopharmaceutical sciences,
engineering or related scientific field with distinct work experience
in pharmaceutical industry, BS or equivalent education and extensive,
Typically, 12+ years of experience; MS or equivalent education with
typically 10+ years of experience; PhD with typically 4+ years of
experience in area or scientific area of discipline. Principal
Scientist I: University degree in biopharmaceutical sciences,
engineering or related scientific field with distinct work experience
in pharmaceutical industry, BS or equivalent education and extensive,
Typically, 14+ years of experience; MS or equivalent education with
typically 12+ years of experience; PhD with typically 6+ years of
experience in area or scientific area of discipline. Experiences
within development of biopharmaceutical products / medical devices /
combination products. Strong p

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