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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description
Provides leadership in manufacturing activities, during the technology transfer, qualification and validation batches associated with new product introductions to the site with a focus on analytical aspects of the process.Ability to execute and troubleshoot API analytical techniques including HPLC, GC, LC-MS, Titration assays, particle size measurement etc. for characterization and process mapping samples.  Knowledge of microbiological test methods a plus.Serves as the primary contact between the Technical Operations team and the QC and global analytical departments to help facilitate test method transfer, troubleshooting and optimization of analytical methods.Provides technical expertise related to manufacturing process and equipment in response to deviations, design of experiment as appropriate to understand and eliminate the root cause(s). Support investigations from chemistry/process perspective for product complaints and deviation.Identify and develop necessary laboratory experiment for continuous improvement projects. Work closely with process engineers and other departments to deliver these continuous improvement projects including change control management.Participate in PHA and quality risk assessment activities providing relevant technical knowledge related to process chemistry and safety. Actively participate to collaboration and learning of best practices with external subject matter experts (SMEs) including GPRD, MS&Ts on process development for suitable future product introduction.Authors technical reports, batch records, SOP’s, investigations, protocols as required and ensures compliance with divisional and corporate policies and guidelines.Any other duties as assigned by supervisor.
Qualifications
Bachelor Degree in a technical/science field, including Chemistry, Biochemistry or Pharmaceutical Sciences.Minimally 4-6+ years of technical experience in process chemistry, pharmaceutical manufacturing process, tech transfer, commissioning and validation in pharmaceutical industry.Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required.Demonstrated process development skills, including the ability to deliver innovative process chemistry at scale.Proven scale up skills, to facilitate the successful transition from laboratory to full scale production.Experience of start-ups and new product introduction to commercial facilities is preferred.Good problem solving skills, embrace problem solving tools like FMEA, 5 Why, able to work under pressure and tight timeline.Team player, highly self-motivated and able to work under minimum supervision.Good command in oral and technical writing in English, and excellent communication and presentation skills.
Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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