Scientist I Biologics Drug Product Development

Company: Disability Solutions
Location: Irvine
Posted on: March 12, 2023

Job Description:

Position Description: The incumbent in this role will support the formulation development of protein biologics from early development (pre-clinical/First-In-Human candidates) through commercialization, with a specific focus on neurotoxins for therapeutics and aesthetic use. This position requires laboratory work in areas requiring select agents and Toxins access (i.e., Biosafety level 2 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives. Responsibilities

• Execute formulation composition and drug product process development studies for sterile liquids, lyophilized, and pre-filled dosage forms
• Manufacture drug product formulation batches for evaluating formulation stability and/or to support animal studies
• Conduct clinical in-use studies to guide dose solution administration
• Interpret results and draw conclusions from multistage experiments; note significant deviations and propose relevant new experiments
• Generate high-quality data based on sound scientific principles and prepare formulation data summaries, technical reports, and scientific presentations
• Support functional technical initiatives by investigating and developing novel experimental approaches and/or technologies in the field of drug product development
• Maintain oversight of day-to-day laboratory activities; manage inventory of raw materials and drug product packaging and manufacturing supplies; coordinate ordering, shipping, and receiving Qualifications -
  • BS with a minimum of 5 years or MS with a minimum of 2 years of experience in pharmaceutics, pharmaceutical sciences, chemical engineering, analytical sciences, or equivalent field in the biotechnology industry
  • CMC development experience in protein formulation, drug delivery, or analytical functions is preferred
  • Candidates must exhibit the technical ability to execute and troubleshoot experiments through rational and critical thinking. Must be highly organized and detail-oriented
  • Hands-on experience with analytical techniques used for protein characterization and stability testing is required (e.g HPLC, spectroscopy, HIAC, MFI, DLS, ELISA, Karl Fisher)
  • Prior experience with drug product manufacture processes and lyophilization is a plus
  • Excellent communication skills required Applicable to California Applicants Only
    • The 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 for this role is posted below
      • This job is eligible to participate in our short-term incentive program
      • This job is eligible to participate in our long-term incentive programs
      • We offer a 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. #wayup 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: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Travel: Yes, 5 % of the TimeJob Type: ExperiencedSchedule: Full-timeCompensationMinimum Salary $66,500 Maximum Salary $130,000

Keywords: Disability Solutions, Irvine , Scientist I Biologics Drug Product Development, Other , Irvine, California