Senior Scientist I / Project Manager, Pharmaceutical Development Combination Products (all gend[...]

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Senior Scientist I / Project Manager, Pharmaceutical Development Combination Products (all genders) (full-time, permanent), Ludwigshafen

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Client:

AbbVie

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

Job Views:

1

Posted:

30.04.2025

Expiry Date:

14.06.2025

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Job Description:

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 48,000employees worldwide and around 3,000 employees in Germany, you will have the opportunity of addressing some of tomorrows 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? Youve come to the right place!

Moving mountains together – asSenior Scientist I / Project Manager, Pharmaceutical Development Combination Products (all genders) (full-time, permanent)

The Project Manager is accountable for leading the cross functional team (Engineering, Quality, Supply Chain, Marketing, Operations, Human Factors, Project Management, and External Partners) in the execution of a portfolio of projects focused on the delivery system constituent parts of a combination product (Devices, Primary Packaging, Accessories, Secondary Packaging, Instructions for Use and Labeling). The Project Manager ensures that the strategy and plans defined for assigned projects are aligned with the needs of the patient and customer and the business objectives of the CMC and Asset team. In addition, product development timing and scope need to support plans for CMC gate reviews and each clinical phase.

Summary of Responsibilities and Accountabilities:

The Project Manager will be accountable to the CMC team, the CMC Product Development Director and delivery system Senior Leadership for delivering on the strategy, plans and budget defined for the project portfolio.

Responsibilities include:

• Leadership of a portfolio of drug delivery system product development projects
• Tactical and strategic management of external device partners including acting as a key interface, managing the project governance process and forward-looking evaluation of potential partners
• Device financial management including budgeting, forecasting and long-range planning of delivery development expenses
• Representing the R&D organization to cross functional leadership through effective and timely communication
• Ensuring effective use of meetings by clearly defining objectives, agendas, inviting the team members specifically needed and publishing minutes and actions
• Driving continuous improvement on Project/project management processes and tools
• Direct management of project managers with responsibility for device/device constituent development projects

Management of External Partners: The Project Manager leads the team in managing the relationship and performance of key external device development partners. An effective and efficient development partner governance process should be defined and implemented including key interface definition, meeting cadence, schedule performance monitoring, project scope/change control, issue escalation, and financial tracking. Project risks must be identified and mitigated with the partner throughout the project lifecycle. The Project Manager will ensure timely and efficient communication regarding partner performance will be provided to the broader AbbVie organization as required. The Project Manager will work with the AbbVie contracts team and the partner to define and track performance to the Statement of Work. The Project Manager will provide accurate and timely cost estimates for budgeting and forecasting.

Impact on AbbVie: The role of Project Manager has broad influence and impact on the development and launch of AbbVie’s assets when a device/combination product delivery system is required. These device systems are often technically complex, involve multiple sub-systems, interface directly with the patient, and must meet global requirements. Typically, external partner management is required. The Project Manager must represent the R&D function to cross functional leadership through effective communication and use of influence skills

Qualifications

Qualifications

• Bachelor’s Degree or equivalent education and typically, 10 years of experience, Master’s Degree or equivalent education and typically 8 years of experience, PhD and no (some) experience necessary.
• Certification: Project Management Professional (PMP) Certification preferred, but not required
• Deep theoretical and practical experience in the combination product, medical device and/or pharmaceutical industry
• Leadership of technical professionals; proven effective leader to cross-functional teams with focus on commercialization, equipment selection, build and qualification of delivery systems
• Skilled in the initiation, selection, coordination, and management of projects and can solve unique problems.
• Requires an in-depth understanding of the pharmaceutical product development cycle.
• Design history file, project management and product development experience are essential.
• Conflict resolution skills including persuasive management techniques required. Effective communication and people management capability.
• Ensure timely execution of incoming reportable device combination product events to comply with global regulations.
• Must have working understanding and application of GMP principles, concepts, practices and standards as well as relevant related regulatory requirements for commercialization in diverse global markets (United States, Europe, Asia, Latin America).
• Up to 25% travel may be required to effectively manage communication between multiple Abbvie sites and third-party suppliers. Fluency in English and German is preferred.

Here's how we can move mountains together

• with a diverse work environment where you can have a real impact
• with an open corporate culture
• with an attractive salary
• with an intensive onboarding process with a mentor at your side
• with flexible work models for a healthy work-life balance
• with a corporate health management that offers comprehensive health and exercise programs
• with company social benefits
• with a wide range of career opportunities in an international organization
• with top-tier, attractive development opportunities
• with a strong international network

Multiple times, we have been globally recognized as a "Great Place to Work" and we are proud to provide our employees with the flexibility to maintain a healthy work-life balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality, equity, diversity and inclusion (EED&I) – a commitment that is fundamental to us. This includes appreciating different perspectives, creating an inclusive culture and treating all employees with dignity and respect.

At AbbVie, your individual contributions count – help us move mountains together. Be a part of our success, grow with us and accomplish more than you could have imagined. Sounds like the perfect career opportunity for you? We look forward to receiving your application! All you need is a complete CV – we will discuss everything else with you in person.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html