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 Senior Scientist you will partner with cross-functional teams to continue building an organization with primary focus on compliance and efficiency, in order to provide first-in-class service to external and internal customers. This candidate with manage critical, commercial laboratory systems and be compliance subject matter expert in a growing organization.
Additional responsibilities for the role on site at a major pharmaceutical company:
- Analysis of cGMP samples utilizing various analytical techniques-HPLC, dissolution, GC, KF, etc., including method validation, method transfer, and stability
- Partner with Corporate Compliance, Quality Assurance, Global Information Services, and Operations-Facilities in execution of QC functions
- Review of technical and compliant cGMP analytical data
- Writing technical methods and reports
- Review of cGMP equipment and software qualifications and repair
What To Expect Next
We look forward to receiving your application. A member of our talent acquisition department will review your qualifications and if interested, you will be contacted for an interview.
Education and Experience:
- Bachelor's degree/Master's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 years’) or equivalent combination of education, training, & experience. OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 2 year)
Knowledge, Skills and Abilities:
- Demonstrated knowledge of multiple analytical techniques in a QC/commercial setting such as: HPLC, GC, MS, Dissolution Testing, Karl Fischer, UV-Vis, FT-IR
- 1 year of GMP experience required
- Demonstrated knowledge with both drug substance and drug product (oral solid dosage forms) testing
- Proficient with electronic notebooks and computerized Quality Management Systems
- Knowledge of Empower Software and Statistical software (JMP, Matlab, Minitab)
- Proficient in Microsoft Excel and Word
- Proven ability to interpret data by performing trend analysis
- Proven ability in technical writing skills
- Ability to independently optimize analytical methods
- Proven problem solving and troubleshooting abilities
- Good written and oral communication skills
- Time management and project management skills
- Ability to work in a collaborative work environment with a team
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, including infectious agents, typically found in healthcare or laboratory environments.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
PPD Defining Principles:
We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD -
If you resonate with our five principles above, and ultimately wish to accelerate the delivery
of safe and effective therapeutics for some of the world’s most urgent health needs, then
please submit your application – we’d love to hear from you.
keywords: HPLC , KF , Commercial , QC , "quality control" , release , stability , dissolution, CMC , GMP