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PPD

Senior Scientist - GMP - Quality Control - SEC

Location: Worcester, MA




In labs and health care facilities worldwide- HERE WE ARE




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 join the Quality Control Department to perform, lead, analyze and/or document laboratory tests within a fast-paced GMP environment in support of one or more of the following areas: raw materials, in-process product, finished product, stability, and/or validation. You will use scientific education and/or experiences to generate results in accordance with GMP/procedural requirements and scientific principles. You will also perform any of the following techniques such as HPLCs, CE-SDS, IEF, and/or SDS-PAGE while working onsite at a major pharmaceutical customer site .

Additional key responsibilities for the role on site at a major pharmaceutical company:
  • Performs method validation, method development, and batch release testing
  • Interpret data output to determine conformance with product specifications
  • Perform trend analyses for assay and product
  • Reviews and verifies data generated by others to determine conformance with product specifications
  • Trains other laboratory personnel on any technique they currently have in their training matrix
  • Train and influences analysts in QC with their tasks and activities
  • Understands, implements, and maintains GMP with respect to laboratory records, procedures, and systems in accordance with procedural requirements
  • Proposes and implements changes to maintain procedural requirements
  • Performs, leads, analyzes and/or documents analytical test methods as written to support product/material release with minimal error
  • Proposes and implements changes to improve laboratory techniques and methodology
  • Independently troubleshoot and resolve analytical techniques and instrument issues
  • Interprets experimental data for conformance with product/material specifications
  • Understands and identifies laboratory technique or instrumental performance in accordance with scientific principles
  • Initiates appropriate exception documents in accordance with procedural requirements
  • Implements and ensures improvement ideas are completed to facilitate team objectives
  • Proposes and implements scientific protocols to determine exception event cause

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!

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.

Job Qualification:

Qualifications




Education and Experience:
  • Bachelor's degree in Chemistry, Biochemistry, Medical Technology, Biology, or equivalent and relevant formal academic / vocational qualification
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 + years)

Knowledge, Skills and Abilities:
  • Proficient in use of analytical instrumentation such as HPLCs, SEC, CEX, UV-VIS, CE-SDS, IEF, SDS-PAGE, ELISA
  • Solid understanding and knowledge of general chemistry and seperation science
  • Solid GMP experience required
  • Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance
  • Empower and LIMS experience required
  • Ability to utilize Microsoft Excel and Work to perform tasks
  • Maintain a laboratory notebook and complete all documentation with clear and accurate language and according to the SOP
  • Proficiency on technical operating systems
  • Proven problem solving and troubleshooting abilities
  • Effective oral and written communication skills
  • Proven ability in technical writing skills
  • Time management and project management skills
  • Ability to work in a collaborative work environment with a team
  • Proven problem solving and troubleshooting abilities
  • Ability to train junior staff


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, including infectious agents, typically found in healthcare or laboratory environments
  • Able to perform successfully under pressure while prioritizing and handling multiple projects or activities

"quality control" , QC, GMP, LIMS, Empower, "method development" , "method validation" , proteins, HPLC, SEC, ELISA

PPDFSP

*LI-NW1

Diversity Statement

PPD 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.

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