SCIENTIST / SENIOR SCIENTIST - GMP, HPLC

Company: PPD
Location: Boston
Posted on: May 16, 2022

Job Description:

JOB DESCRIPTIONThis position requires long-term eligibility to work in the US without sponsorship.Please note: F-1 OPT Visas are not considered long-term eligibility for this role.
PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD Laboratories FSP. PPD Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.

As a Scientist/Senior Scientist, you will use state-of-the-art technologies to support small molecule programs through analytical method development/validation, clinical supply release and stability sample analysis for both drug substance and drug product material in a GMP environment at the client lab facility.

Additional responsibilities for the role on site at a major pharmaceutical company:

• Perform cGMP analysis and data interpretation for various techniques such as HPLC, GC, KF, TOC, IR and dissolution on small molecules.
• Compile and summarize analytical raw data in various physical and electronic report formats.
• Maintains accurate records of experiments and results in a laboratory notebook and authors reports as assigned.
• Demonstrates knowledge of scientific principles and basic understanding of applicable drug development regulations.
• Data entry and various administrative functions for laboratory data systems.
• Maintain cGMP training compliance.
• May participate in regulatory agency audits and inspections.
• May perform peer review of analytical data and results
  At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk; our award-winning training programs speak for themselves.
  Join PPD in our relentless pursuit of excellence - apply now!Job Qualification
  Education and Experience:
  • Bachelor's degree in Chemistry, Analytical Chemistry, Pharmaceutical Chemistry or equivalent and relevant formal academic / vocational qualification
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years) or equivalent combination of education, training, and experience.
  • Senior Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years) or equivalent combination of education, training, and experience.
  • In some cases, an equivalency consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
  • 2 years of GMP and HPLC experience
    Preferred Experience:
    • Waters Empower, SLIM data management, or IDBS Electronic Lab Notebook (ELN) and/or electronic quality management system experience preferred
      Knowledge, Skills and Abilities:
      • Knowledge of applicable regulatory authority, compendia and ICH guidelines
      • Ability to understand and independently apply GMPs and /or GLPs to everyday work with regard to documentation and instrument use
      • Ability to utilize Microsoft Excel and Word to perform tasks
      • Ability to independently execute analytical methods
      • Good written and oral communication skills
      • Time management and project management skills
      • Problem solving and troubleshooting abilities
      • Ability to work in a collaborative work environment with a team
        Working Environment:PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
        • Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner
        • Able to work upright and stationary and/or standing for typical working hours
        • Able to lift and move objects up to 25 pounds
        • Able to work in non-traditional work environments
        • Able to use and learn standard office equipment and technology with proficiency
        • May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments
        • Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
          #LI-MR1PPDFSP
          Diversity StatementPPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.COVID-19 Vaccination Update for U.S. Colleagues
          • All U.S. colleagues are required to report vaccination status. New hires will be asked to report vaccination status within the first two weeks of employment.
            
            • All U.S. new hires who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), remote site monitors-local (RSM-L) all CRA and RSM-L line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles. New hires will be asked to disclose vaccination status upon first day of employment and are required to report vaccination status within first two weeks of employment.

Keywords: PPD, Boston , SCIENTIST / SENIOR SCIENTIST - GMP, HPLC, Other , Boston, Massachusetts