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PPD

Research Scientist - Biopharm cGMP Reports, and Regulatory Documentation

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.  

 

The Research Scientist position conducts and provides technical guidance on scientific method development and validation projects and/or other specialty technologies studies OR performs troubleshooting for own and others instruments, methods, procedures, and in writing protocols and reports.


For this position within Analytical Lifecycle Management, you will be responsible for building and enhancing biopharmaceutical expertise to be further embedded in the business.

Responsibilities:
•  Contribute to the implementation of business processes and best working practices to ensure Analytical Lifecycle Management, operates strategically and as efficiently as possible.
•  Independently authors reports, protocols, policies/plans or regulatory submissions.
•  Supports department objectives in alignment with project objectives.
•  Anticipates and recognizes potential problems, initiates actions to solve or prevent problems and communicates issues/risks to project lead and manager.
•  Contribute to the successful and timely transfer of Late Phase BioPharm Analytical methods/technologies to and from R&D development, contract manufacturer’s, testing labs, or commercial manufacturing organizations.
•  Effectively prioritizes activities to meet project or department objectives using demonstrable project management skills.
•  May lead a project, matrix team or small focus groups.
•  Plays a significant part in the project team decision making process.
•  Consistently exhibits professionalism and courtesy
•  Presents effectively to internal R&D forums and may present results at external meetings.
•  Keeps manager and matrix team leaders informed of progress and activities.


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. 


Our teams support career growth whether you are looking for long term opportunities within the scientific ladder, to pursue project management, or develop into a leader -- these are just a few career pathways available once your become a part of the PPD team. 


To learn how PPD can advance your career, apply now!

What To Expect Next
We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.

PPDFSP

Qualifications

Education and Experience:
  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years).
Knowledge, Skills and Abilities: 
  • Intermediate knowledge of general chemistry and separation science
  • Thorough knowledge of cGMP requirements and at least one year of industry experience in a cGMP regulated lab.
  • Previous experience in Analytical Technology Transfer and Validation
  • Familiarity with FDA/EU/ICH regulations and guidance particularly as they relate to Analytical Release and Stability Testing, Product Characterization, and Comparability Assessment.
  • Independently applies knowledge in area of specialization to assignments that involve multiple decision points.
  • Familiar with GLP regulations.
  • Previous Biopharmaceutical experience is required.
  • Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance
  • Full knowledge of technical operating systems
  • Ability to independently optimize analytical methods
  • Ability to independently perform root cause analysis for method investigations
  • Proven technical writing skills
  • Proven problem solving and troubleshooting abilities
  • Effective written and oral communication skills as well as presentation skills
  • Time management and project management skills
  • Ability to mentor others on technical operating systems
  • Ability to independently review and understand project proposals/plans
  • Ability to work in a collaborative work environment with a team

PPD values the health and wellbeing 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 of laboratory environments
  • Able to perform successfully under pressure while prioritizing and handling multiple projects or activities

Apply Now

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