In this role you will drive the development of Container Closure Systems (CCS) for new parenteral products supporting some of AbbVies most important pipeline assets including monoclonal antibodies antibody-drug conjugates and therapeutic toxins. You are an expert in the characterization of CCS (vials prefilled syringes prefilled cartridges) with a strong focus on Container Closure Integrity (CCI). Your work includes development and validation of CCI methods technical support for CCS qualification in pharmaceutical manufacturing and the evaluation and implementation of innovative CCI technologies.
Your responsibilities are:
Plan prepare execute and evaluate experiments for the development of container closure systems for new parenteral drug products focusing on liquid biotechnological drug products in vials prefilled syringes and cartridges including scale-up activities
Act as a subject matter expert for the technical evaluation development and continuous improvement of CCI methods based on a holistic CCI strategy and current regulatory as well as economic considerations
Initiate and supervise collaborations with internal and external partners (for CCI method development technique implementation and characterization based on various CCI technologies and data)
Ensure compliant documentation of all experimental work and contribute to the preparation and review of internal procedures
Prepare and review technical documents such as method development reports and risk assessments that may serve as source documents for regulatory filings method transfers and related activities
Qualifications :
This is how you can make a difference:
Bachelors degree or equivalent education with typically 5-7 years of experience or Masters degree with typically 2-5 years of experience
Degree in pharmacy biology biotechnology chemistry process engineering material sciences physics or a related field
Highly motivated personality with a proactive solution-oriented mindset
Strong technical and scientific understanding of parenteral product development
Ability to interpret relevant scientific literature and apply theoretical concepts to solve problems within the scientific discipline in a timely manner as well as proven scientific expertise in statistical data analysis
Strong team player with the ability to manage and resolve conflicts constructively in combination with good verbal and written communication skills in German and English
Ability to create comprehensive scientific and project documentation in English
Additional Information :
Heres how we can move mountains together:
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.
Have questions Email We look forward to hearing from you!
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.
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No
Employment Type :
Full-time
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more