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Principal Research Scientist I - Skincare Product Development -Tech Transfer

Company: Disability Solutions
Location: Irvine
Posted on: March 18, 2023

Job Description:

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
      • Perform PTP activities
      • Meet with TPM and CMOs for product transfer discussions
      • Coordinate with CROs and CMOs for process innovation activities
      • Provide technical support to S&T/Quality
      • Write process development reports 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 Applicable to California Applicants OnlyThe below range is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range and this range is only applicable for jobs to be performed in California.This range may be modified in the future.The salary range is (minimum: $ 110,500 to maximum: $ 216,000)This job is eligible to participate in our short-term incentive programThis job is eligible to participate in our long-term incentive programsWe offer comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
              • Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.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.Significant Work Activities: N/ATravel: NoJob Type: ExperiencedSchedule: Full-timeCompensationMinimum Salary $110,500 Maximum Salary $216,000

Keywords: Disability Solutions, Irvine , Principal Research Scientist I - Skincare Product Development -Tech Transfer, Education / Teaching , Irvine, California

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