- Responsible for biologics manufacturing process technical support and improvement initiatives for ongoing operations. May have responsibility for operations encompassing all aspects of cell culture and/or purification depending on required scope and experience
- Provides leadership to manufacturing activities during the technology transfer, qualification and validation batches associated with new product introductions to the site
- Supports operational efficiency goals for yield, product quality and other product and/or site KPI’s
- Contact and consultant for process/equipment troubleshooting and investigation activities.
- Actively promotes a culture of GMP and EHS compliance with all applicable policies and guidelines and supports risk assessment activities providing relevant technical knowledge
- Provides support to regulatory filings and audit activities
- Provides support for process cleaning/changeover strategies (CIP/SIP), media/solution preparation and benchtop analytics as required
- Authors technical reports, batch records, SOP’s, investigations, protocols as required and ensures consistency and quality of the group’s documentation
- Any other duties as assigned by supervisor
- BS, MS or PhD in scientific or engineering filed with 3-6 years of related experience depending on degree. Target fields include chemical/biochemical engineering or a related technical/science filed encompassing biotechnology
- Ability to lead a team (either direct reports or indirect stakeholders) and develop employees
- Detailed Knowledge of cGMP and regulatory requirements relating to the biopharmaceutical industry is required
- Technical experience with process scale-up, bioreactors, column chromatography and packing, UF/DF, filtration technologies and single-use systems all desirable
- Knowledge of E/F/U validation including cleaning strategies and CIP/SIP
- Experience with start-ups and new product introduction to commercial facilities is preferred.
- Good problem solving skills and use of tools like FMEA, 5 Why’s with the ability to work under pressure and deliver on tight timelines
- 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 skill
- Site operations including Production, Engineering, QA/QC, Supply Chain and IT
- Global functions managing technology transfer, infrastructure and systems such as Global Technical Operations
AbbVie is an equal opportunity employer including disability/vets. 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.