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Senior Scientist - GMP, Method Development , ELISA , PCR

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 SeniorScientist, you will provide support to the Analytical Development team. You will execute large molecule cell-based assays, analytical method development and validation for protein drug substance and protein drug product while working onsite at a major pharmaceutical client lab facility.

Additional Responsibilities while work onsite at a major pharmaceutical customer site:
  • Developing and validating cell based assay, cell-culture, PCR, ELISA, and bioassay methods as per ICH and GMP guidelines
  • Develop new chemical assays; write method validation protocols and reports
  • Ability to identify and solve complex technical issues that correspond to atypical or out-of-specification/trend test results as well as instrumentation and methodology related issues.
  • Write and disseminate technical data summaries and reports
  • Direct and foster training of scientific associates
  • Routine work involvement and weekly meetings with laboratory team to review progress, work through issues and bring resolution to problems, and communicate to laboratory management and coordinate with other technical leaders for assistance and closeout of work activities
  • Design experimental plans to address specific program issues
  • Interpret, analyze, and manage data
  • Troubleshoot technical problems
  • Present plans and data to key stakeholders and management

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.

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

Job Qualification:

Education and Experience:
  • Bachelor's degree in Molecular or Cellular Biology, Biochemistry, or Chemistry, or equivalent and relevant formal academic / vocational qualification
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 4+ years) or equivalent combination of education, training, & experience.
  • Master's degree in Molecular or Cellular Biology, Biochemistry, or Chemistry, or equivalent and relevant formal academic / vocational qualification with comparable 2+ years industry experience
  • Ph.D. in Molecular or Cellular Biology, Biochemistry, or Chemistry, or equivalent and relevant formal academic / vocational qualification with comparable 0-2+ years industry experience
Preferred Experience:
  • Master's degree or Ph.D. in Molecular or Cellular Biology, Biochemistry, or Chemistry, or equivalent and relevant formal academic / vocational qualification with 2+ years of industry experience
  • Previous industry experience performing cell based method development and validation in GMP environment per ICH guidelines
Knowledge, Skills and Abilities:
  • Knowledge of Bio-Pharmaceutical Sciences and Development
  • Ability to perform cell based method development and validation, ELISA, PCR, cell culture, bioassay
  • GMP method development and method validation required
  • Previous experience in cGMPs and ICH guidelines required
  • Ability to independently perform root cause analysis for method investigations
  • Proficiency on technical operating systems, ELN, Empower, Chemstation a plus
  • Proven problem solving and troubleshooting abilities
  • Proven ability in technical writing skills
  • Time management and project management skills
  • Good written and oral communication skills
  • Ability to work in a collaborative work environment with a team
  • Ability to train junior staff
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, 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.

GMP , "method development" , "method validation" , bioanalytical , PCR, ELISA , "cell-based" , "large molecule" , bioassay,

protein, molecular



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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