Senior Scientist*in (all genders) Product Development Science & Technology (PDS&T) - Global Material and Parenteral Packaging Sciencesbaito Pro Job

Senior Scientist I / Senior Scientist II (all genders) Product Development Science & Technology (PDS&T) - Global Material and Parenteral Packaging Sciences (permanent) (full- or part-time)

Ludwigshafen, RP

1. Function: Operations

2. Area of Interest: Biotechnology

3. Job Type Full-time

Job ID: R00116893

Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram and LinkedIn.

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 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? You’ve come to the right place!

We are seeking a Senior Scientist to support the Global Material and Parenteral Packaging Science team within Product Development Science & Technology (PDS&T) for New Biologic Entities (NBE).

Direct project activities regarding Container Closure System (CCS) development for AbbVie’s early- and late-stage parenteral Antibodies, Antibody-Drug Conjugates as well as Eye Care and Neurotoxin products. Independently conceive, develop, and manage all aspects of CCS landscaping and characterization for Vials, Prefilled Syringes (PFS) and Cartridges to support drug product and combination products requirements.

In your role as technical expert for CCS you will work collaboratively with experts in multi-functional teams and serve as Technical Lead on his/her own project and contribute CCS insights into multiple other projects from early development through to product launch, and technical commercial support (e.g. change control and investigations) and life cycle management.

The candidate will be working on the development of container closure systems (CCS) and manufacturing processes within the PDS&T organization at AbbVie.

Responsibilities

• Lead, design, and evaluate the development of innovative materials and/or alternate primary packaging materials, packaging solutions or packaging systems for sterile dosage forms
• Expert knowledge in container closure system qualification, functional characterization, container closure integrity (e.g. USP <1207>) and Extractable & Leachables (E&L) according to regulatory requirements (e.g. USP <661> and <665>, ISO10993, ICHQ3D)
• Provide technical leadership of primary packaging selection and validation, development of component specification for primary packaging components internal/external tech transfer including Life-Cycle-Management (LCM), change control and investigations
• Profound knowledge in pharmaceutical drug product manufacturing processes, qualification and implementation of primary packaging components. Partner with device development team to ensure system level requirements for combination products are developed, verified, and validated in accordance with design controls requirements
• Develop strong cross-functional relationships with manufacturing, process development, Quality Control and Quality Assurance to enable effective resolution to technical issues and drive continuous process improvement
• Represent the PDS&T group in cross functional business teams including Operations, Planning, Purchasing, Quality, Process Sciences, Regulatory Affairs, and Marketing to design, select, develop, test, and commercialize new packaging components and/or systems
• Excellent interpersonal skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside AbbVie
• Excellent oral and written communication skills including the ability to create sound technical documents, including scientific and technical documents, development reports, design history files and documents for CMC submissions

Qualifications

• Senior Scientist II: Bachelor’s Degree or equivalent education and typically, 12 years of experience, Master’s Degree or equivalent education and typically 10 years of experience, PhD and typically 4 years of experience. Degree in Pharmaceutical Technology, Analytical Chemistry, Material Sciences, Chemistry, Physic, or related fields

• Senior Scientist I: 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 some experience necessary. Degree in Analytical Chemistry, Material Sciences, Chemistry, Physic, or related fields

• Professional training may be substituted for equivalent knowledge gained through work experience as an Associate Scientist/Scientist

• Expert knowledge in parenteral manufacturing and CCS development in either pharmaceutical, medical device or biotech industry is required

• Profound knowledge in E&L concepts, functional CCS characterization and Container Closure Integrity (CCI) analysis according to a holistic CCI strategy

• Experience in analytical method development and validation according to USP, ICH or other compendial or regulatory requirements

• Broad expertise around regulatory requirements for parenteral pharmaceutical and biopharmaceutical products, primary packaging materials and drug/device combinations products expected

• Good track record in mentoring and guiding of a team of scientists

• Experiences with authoring and reviewing regulatory submissions and authority questions of biotechnology drug products

• Excellent oral communication skills as well as sound technical writing and documentation competencies are required

• The candidate must be able to work independently, respond to changing priorities and short lead times for multiple tasks; able to identify problems and work toward solutions; able to influence without direct authority in multi-disciplinary teams; must be attentive to details and have excellent organization skills

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.

Any questions? Feel free to email as at TalentAcquisition.de@abbvie.com – we look forward to hearing from you!