AbbVie

Principal Pharmaceutical Scientist I

Employer
AbbVie
Location
Barceloneta, Puerto Rico
Posted
Jun 14, 2021
Ref
2108803
Required Education
Doctorate/PHD/MD
Position Type
Full time
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

  • Be recognized within the organization as a technical expert and subject matter expert (SME)in all aspects of drug product manufacturing such as product formulation, pharmaceutical unit operations, process validation strategies, pharmaceutical drug product formulation, and design of experiments (DOE). Provides technical guidance to scientists at all levels.
  • Writes/co-author/reviews/approves technical/scientific reports or justifications to support and/or document process deviations/investigations and recommendations for corrective actions, determine the impact in product quality, support regulatory submissions, and field alerts.
  • Responsible for the development of a validation strategy and execution of the strategy to validate the new processes, technology, or raw materials and for maintaining current processes in a validated status. Capable of preparing validation/qualification protocols in compliance with current policies.
  • Lead Technology Transfer projects to support scale-up activities related to new product introductions (NPI) projects as clinical batches and other experimental batches. Designs and develop experimental or engineering lots to implement a new procedure for reprocessing, rework, or new technology.
  • Responsible for maintaining the process in a robust state by monitoring the process capabilities and develops remediation plans if and when and if processes are out of statistical control.
  • Expected to advise and have decisional responsibility as a member of the Validation Review Board.
  • Should be an active participant during regulatory inspections in many roles such as SME, defense packages, and response strategy development.
  • Responsible to develop and implement operational changes that will achieve an increase in product yield, quality, throughput, materials management, and reduce cost.
  • Leads root cause analysis cross-functional sessions by utilizing recognized tools for problem-solving and root cause analysis determination.
  • Serve as a technical liaison between plant operations and quality personnel and support functions such as R&D, MST central function, other tech centers, analytical development, engineering, and regulatory affairs.

Qualifications
  • BS (Chemistry, Pharmacy, Chemical Engineering or relevant discipline) min 12 years Technical Experience in Oral Drug Products Manufacturing Industry.MS (Chemistry, Chemical Engineering, Industrial Pharmacy, or relevant discipline) min 8 years Technical Experience in Oral Drug Products Manufacturing Industry.PharmD min 6 years of Oral Drug Products Manufacturing Industry.Ph.D. (Chemistry, Pharmaceutics, or Chemical Engineering) min 6 years Technical Experience in Oral Drug Products Manufacturing
  • Excellent Technical Writing Skills with proper use of English grammar.Must work independently with little supervision and be a self-starter. Ability to work in a team and in a larger role in conjunction with R&D, MS&T, and Technical Operations from other manufacturing sites.Has the ability to anticipate, recognizing, and resolving problems. Utilizes recognized tools for root cause determination and addresses problem-solving in a structured manner.
  • Ability to respond rapidly to the manufacturing process and laboratory needs and have a strong sense of urgency. Capability to respond and adjust to changes in priorities, including work during nights and weekends. Capability to work in a dynamic environment with many groups simultaneously while maintaining a high degree of quality work output.Ability to work with and handle multiple projects and priorities.Capability to apply and teach and coach group members on scientific & technical concept
  • Problem Solving: Direct and design the corresponding experiments and investigations to resolve the problems. Determine the assignable causes from such investigations and implement corrective actions and/or preventative measures.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 20 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.