Principal Research Scientist I - Skincare Product Development -Tech Transfer

The incumbent will be responsible for smooth product transfer from R&D to Manufacturing Sites within US. He/she will:

• Work hands on in the laboratory on process development experiments ensuring a robust process design
• Perform scale up studies on the bench, pilot, and commercial scale and participate in process validation as needed
• Travel to contract manufacturing sites to monitor the scale up studies on pilot, and commercial scale trials
• Support risk mitigation strategies for commercial activities
• Participate in development of study protocols for qualifications, validations, investigations, and stability studies
• Interact with cross functional teams such as Formulation, Quality, S&T, CMO, Project Management, Supply Chain etc. for coordinating R&D efforts on the new product transfer
• Write Process Development reports
• Collaborate with Science and Technology group, participate in execution of process validation as needed 
• Help Process Innovation efforts in development of next generation technologies 
  • Engage CROs and CMOs to support development of new technologies 
  • Support commercialization and tech transfer of new process innovation 
  • Provide technical support to Quality and S&T on the marketed products 
  • Stability Studies 
  • Specification revision  
  • Customer Complaints  
  • OOS investigations 

Key Duties / Responsibilities:

• Perform hands on lab experiments on process development

            % of Time: 40%

• Perform PTP activities

            % of Time: 20%

• Meet with TPM and CMOs for product transfer discussions

            % of Time: 20%

• Coordinate with CROs and CMOs for process innovation activities

            % of Time: 10%

• Provide technical support to S&T/Quality

            % of Time:  5%

• Write process development reports

            % of Time: 5%

Education and Experience

• Equivalent to 4 or more years of college education - with preference in scientific disciplines (Chemical engineering, bioengineering, biomedical engineering, chemistry or equivalent)
• Must have a minimum of a BS with 14+ years (MS with 12+ or PhD with 6+ years) of experience in process development & scale up of skincare (preferred), personal care, semi-solid regulated products (pharmaceutical, medical devices)
• Must have experience of scale-up, manufacturing, validation, CMC, statistical analysis
• Expertise in qualification/validation studies and statistical analysis
• Knowledge of equipment and processes in the semi solid manufacturing.
• Expected to establish and maintain positive relationships with management and co-workers and work well in a team environment
• Must be self-motivated and show willingness to take on new approaches/technologies and additional responsibilities
• Attention to detail and accuracy is required
• Able to multi-task and handle multiple projects with various deadlines
• Must demonstrate excellence in oral and written communications
• Computer proficiency with common PC software such as Microsoft Office and Excel

Essential Skills and Abilities

• Excellent analytical and organizational skills, self-starter, motivated
• Excellent interpersonal skills and written and oral communication skills
• Proficient computer skills, statistical and analytical tools

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action 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. If you would like to view a copy of the company’s affirmative action plan or policy statement, please email CorpJat_ABV@abbvie.com.