AbbVie (NYSE: ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. AbbVie combines the focus and passion of a leading-edge biotech with the expertise and capabilities of a long-established pharmaceutical leader to develop and market advanced therapies that address some of the world’s most complex and serious diseases. In 2013, AbbVie will employ approximately 21,000 people worldwide and markets medicines in more than 170 countries.
Primary Function / Primary Goals / Objectives:
Support the AbbVie Technical Operation functions and the AbbvieTechnical Centers worldwide.
Resolve manufacturing issues for commercial and Research and Development products.
Provides technical support to cross-functional teams during development, commercial launch or problem solving for a given drug product.
Liaison between functional groups as well as sister divisions (ie Operations, Quality, Regulatory, Validation, Materials Management, GPAS, Analytical Test Labs, Stability, API, AI and SPD)
Can work independently on an as needed basis.
Capable of providing technical support on a given project team.
Provide individual technical support of all scale-up activities and maintain timelines for on-going projects.
Write/co-author process memos and scientific reports in support of Regulatory Submissions, Regulatory Field Alerts and supportive quality control and manufacturing documents.
Responsibility of writing deviations, NCMRs and investigations in terms of the technical content.
Ability to recognize and resolve problems.
Provides guidance/mentoring for post-doctoral candidates in the department.
Provides technical support for introduction of new products and for process improvements to existing products.
Can be member of VRB (Validation Review Board) where involvement consists of reviewing all changes in the plant that require validation and provide technical support of product validation.
Accountability / Scope:
Accountable to suggest and direct product improvements or alternate manufacturing strategies that meet the highest standards in quality, customer service and regulatory compliance.
Errors in process changes could lead to audit citations and regulatory action.
Decisions may affect projects.
BS with 3-5 years of experience preferred. OR
MS with 1-3 years of experience preferred. OR
Pharm.D or Ph.D; with 0 years of experience preferred.
Technical background in pharmaceutical dosage forms.
Has problem solving abilities.
Scientific report writing skills.
Knowledge and experience in working in a cGMP environment.
Knowledge of regulatory issues involved with CMC.
Good organizational skills.
Excellent communication (oral and written) and interpersonal skills.
Functions as a team player.
Has knowledge of related areas of development to incorporate into local problem solving.
Must be able to work with commercial operations to determine prioritization of projects and meet tight timelines.
Use good judgment to make sound decisions.
Needs to be adaptable and maintain the ability to give clear directions flexible in an ever changing and challenging environment.
Significant Work Activities and Conditions
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
RESEARCH AND DEVELOPMENT