SCIENTIST - HPLC, GMP

JOB DESCRIPTION

This 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, you will use state-of-the-art technologies to support early to late phase pharmaceutical development programs through analytical method 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
• Shift: Monday-Friday: 8am-5pm EST

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 2+ years) or equivalent combination of education, training, and experience.) OR Master's Degree with preferred 1+ years of 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.

Preferred Experience:

• Waters Empower, SLIM data management, or IDBS Electronic Lab Notebook (ELN) and/or Trackwise 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

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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.