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PPD Scientist - Biologics Operational role in New Brunswick, New Jersey

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 provide technical guidance on scientific method development and validation projects. You work as a project leader and routinely conference with clients on multiple projects, provide updates, review and evaluate data, as well as writing reports and protocols.

*Responsibilities for this role:*
This position will directly support biologics operational activities for the Reference Standard and Critical Reagent (RSCR) Group in New Brunswick, NJ within the Client's Global Quality Analytical Science & Technology (GQAST) organization.

Primary role will be to support all aspects of inventory maintenance for biologics reference standards and critical reagents within the RSCR Operations group including (but not limited to) technical reviews, shipment documentation, maintenance of global standards inventory, and coordination of shipments to stakeholders as well as performing lab-based work (such as aliquoting, homogeneity), as needed.

Depending on the candidate’s aptitude/experience the role could be expanded to help manage aspects of project- specific reference standard and critical reagent procurement and testing as well as cells and sera.

Work with Biologics Operations Manager to manage inventory and scheduling to meet project deliverables and timelines. Maintain sustained communication with stakeholders and area management regarding material supplies and deliverables. Sustained collaboration with key stakeholders and operational partners. Closely monitor key aspects of the business such as inventory and burn rate analysis, and actively communicate/escalate to senior leadership when appropriate. Work
well within diverse/inclusive high performance teams and maintain a strong relationship with operational and functional leadership.

*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


_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 2 years).
  • 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.

*Knowledge, Skills and Abilities:  *

  • Broad knowledge of protein and peptide chemistry, biochemistry, and practical experience in testing (ELISA, Gel Electrophoresis, Peptide Mapping, Amino Acid Analysis)
  • Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance.
  • Strong theoretical and hands-on understanding and knowledge of biologics and critical reagents
  • Full knowledge of technical operating systems
  • Ability to independently optimize analytical methods
  • Ability to independently perform root cause analysis for method investigations
  • Proven ability in 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

*Working Environment:  *
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, including infectious agents, typically found in healthcare or laboratory environments. 

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. 

Job: *Labs

Organization: *US BU

Title: Scientist - Biologics Operational role

Location: NJ-New Brunswick-FSP New Brunswick NJ

Requisition ID: 200840

PPD is an affirmative action employer that values diversity as a strength fosters and environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group