Scientist II - HPLC, GMP

Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our PPD Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

As a Scientist II you will work in a multi-functional environment supporting drug development and will collaborate in cross-functional teams. You will accomplish our mission through innovation and partnership, creative problem-solving, and use of state-of-the-art technology.

A Day In The Life

• Trains on routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory procedures and guidelines.
• Performs a variety of routine to complex sample preparation and analysis procedures with minimal supervision/guidance to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices for stability and analytical testing.
• Completes all laboratory documentation in clear and accurate language and according to SOP and GLPs.
• Independently troubleshoots equipment & instruments.
• Mentors’ others in troubleshooting when applicable.
• Reviews and compiles results from assignments and makes initial determination on acceptability per SOP acceptance criteria.
• Performs work assignments accurately, and in a timely and safe manner.
• Independently manages QC responsibilities.
• Communicates project status to project leader and helps to identify gaps and anticipate roadblocks in project team workflow.
• Completes QA facing tasks with minimal supervisor/QA input.
• Authors low complexity quality records and participates in the OOS/OOT/Atypical investigation process.

Education

Bachelor's degree in lab sciences such as chemistry, biochemistry or similar.

Experience

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

Knowledge, Skills, Abilities

• Previous experience with HPLC or Dissolution testing and method validation preferred.
• Knowledge of routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory guidelines.
• Knowledge of applicable regulatory authority, compendia and ICH guidelines.
• Demonstrates excellent manual dexterity skills, allowing for precise and accurate work.
• Exhibits strong written and oral communication skills, facilitating effective communication within the team and with stakeholders.
• Displays exceptional time management and project management skills, ensuring efficient completion of tasks.
• Proven problem-solving and troubleshooting abilities, enabling the identification and resolution of issues.
• Capable of cross-training on sample preparation techniques with another laboratory group, enhancing versatility and collaboration.
• Thrives in a collaborative work environment, actively contributing to a cohesive and productive team.

Work Environment Requirements

• 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 prioritising and handling multiple projects or activities.

Our Mission is to enable our customers to make the world healthier, cleaner and safer.