Senior Scientist I – Biologics Analytical R&D (BARD) (all genders) (full-time, temporary for 24 months)

Ludwigshafen, RP

• Function: Research & Development
• Job Type: Full-time

Job ID: R00132577
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.
Job Description

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
  Multible 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 TalentAcquisition.de@abbvie.com – we look forward to hearing from you!
  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, visit https://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.htm

Senior Scientist I: You hold a bachelor’s degree or equivalent education and typically 10 years of experience, a master’s Degree or equivalent education and typically 8 years of experience, a PhD and no (some) experience necessary.

• Expert knowledge in GMP requirements for analytical laboratories for biological entities (NBEs) is mandatory. This involves e.g. GMP-compliant documentation of analytical data, conducting laboratory investigations and profound understanding of standard operating procedures. Experience with electronic lab notebook is beneficial.
• Due to previous work, you are very experienced in analytical development for biological entities supporting FIH study initiation up to commercialization. Candidate’s portfolio must consist of chromatographic separation techniques like HPLC/UPLC coupled to various detection systems as well as other techniques such as Peptide Mapping, icIEF, CE and compendial test methods. In depth experience in chromatography data systems, e.g.Empower is required.
• Experience in Quality by Design (QbD), Design of Experiment (DoE) and statistical interpretation of data (e.g. for Comparability) are advantageous as well as experience in other biological entity related areas like formulation, process development or manufacturing are beneficial.
• Experience with third party laboratory management is beneficial
• Strong analytical and problem-solving capabilities and skills
• Ability to multitask and work within timelines is mandatory.
• You have a basic understanding of both scientific and regulatory requirements in the area of pharmaceutical development
• As a highly motivated, self-driven and results-oriented person with excellent communication and presentation skills you are experienced in a cross-functional, global environment, used to work with teams in a matrix.
• As a global acting company, we presume excellent communication skills, including written and oral English

• You are responsible for the evaluation, optimization and establishment of innovative analytical methods to characterize and control active pharmaceutical ingredients, stabilizers and excipients in drug substances and drug products as well as related impurities during pharmaceutical development of biological products within the BARD organization.
• You ensure successful and timely execution of BARD projects in house and/or at a third party lab.
• You are keen on establishing and continuously improving approaches related to BARD analytical development concepts across our project portfolio.
• You assess analytical test methods for quality control as well as characterization purposes and create source documents for agency applications and publications.
• You interpret analytical data and conclude quality relevant parameters and ensure GMP-compliant documentation.
• You support the head of quality control through assessment, review and finalization of changes, deviations and out-of-specification investigations
• You build strong cross-functional networks in local and global environments and are responsible for subject matter expert topics along with their representation in local and global teams.
  Qualifications

Senior Scientist I: You hold a bachelor’s degree or equivalent education and typically 10 years of experience, a master’s Degree or equivalent education and typically 8 years of experience, a PhD and no (some) experience necessary.

• Expert knowledge in GMP requirements for analytical laboratories for biological entities (NBEs) is mandatory. This involves e.g. GMP-compliant documentation of analytical data, conducting laboratory investigations and profound understanding of standard operating procedures. Experience with electronic lab notebook is beneficial.
• Due to previous work, you are very experienced in analytical development for biological entities supporting FIH study initiation up to commercialization. Candidate’s portfolio must consist of chromatographic separation techniques like HPLC/UPLC coupled to various detection systems as well as other techniques such as Peptide Mapping, icIEF, CE and compendial test methods. In depth experience in chromatography data systems, e.g.Empower is required.
• Experience in Quality by Design (QbD), Design of Experiment (DoE) and statistical interpretation of data (e.g. for Comparability) are advantageous as well as experience in other biological entity related areas like formulation, process development or manufacturing are beneficial.
• Experience with third party laboratory management is beneficial
• Strong analytical and problem-solving capabilities and skills
• Ability to multitask and work within timelines is mandatory.
• You have a basic understanding of both scientific and regulatory requirements in the area of pharmaceutical development
• As a highly motivated, self-driven and results-oriented person with excellent communication and presentation skills you are experienced in a cross-functional, global environment, used to work with teams in a matrix.
• As a global acting company, we presume excellent communication skills, including written and oral English.