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PPD

Scientist - FTIR NMR and GMP

 

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.  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 perform a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices. 

 

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and well being of our employees.   

 

Position Summary:

Versatile, pharmaceutical product development GMP laboratory seeks a hardworking, results-focused analytical chemist with experience in supporting small molecule pharmaceutical programs at Bristol-Myers Squibb.  The position will require position relevant expertise in vibrational spectroscopic and physical testing of drug substances, drug products, excipients and raw materials used in the manufacturing and formulation of clinical small molecule drug substances and clinical drug products.  This position will be located at the BMS New Brunswick, NJ (NBR) site, reporting directly to a Lab Manager within the GxP Raw Materials Group of the Analytical Strategy & Operations (ASO) department.

 

Duties and Responsibilities:
Essential Duties and Responsibilities include, but are not limited to, the following:
•    Demonstrate practical knowledge of analytical techniques to contribute to development of phase-appropriate robust and reproducible analytical methods for use in the GMP clinical laboratory.
•    Independently perform analytical testing including but not limited to FTIR, NIR and Raman spectroscopy methods, color & appearance tests, hardness testing, pH measurements, compendial methods, and wet chemistry techniques.  Executed tests support clinical release and stability testing of drug substances, drug products, excipients and raw materials used in the manufacturing and formulation of clinical small molecule drug substances and clinical drug products.
•    Independently execute analytical method qualifications, validations and transfers (as applicable) to QC laboratories.  Carefully adhere to approved protocols.
•    Contribute to study design and the authoring of analytical methods, protocols and reports.
•    Maintain clear, complete, accurate and GMP-compliant documentation for experiments.
•    Proactively provide clear, timely communication of potential issues to management.
•    Organize and present data for internal and external scientific meetings.

 

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. 


PPDFSP

 

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: 

  • The candidate must demonstrate good communication skills, particularly in documentation of data and writing reports and methods.  Skill in communicating/escalating critical issues to appropriate team leaders and functional area management is necessary.

  • At least one year of experience in a GMP regulated lab is required.

  • The candidate must be able to deliver when working under assigned timelines.

  • Understanding of cGMP/GLP and GDPs practices and EHS requirements is essential.  Ability to comply with all applicable SOPs, internal ADT requirements and external regulations is a must.

  • Expertise in MS Office applications, in particular MS Word and Excel, is required.  Familiarity with electronic documentation systems (e.g. Qumas, Infinity, Syncade-DCA) for routing protocols/reports, investigation reports for review and approval is a plus.

  • Experience in use of scientific reporting applications and ELN software, e.g., VelQuest, Symyx and LIMS, preferred.

  • Demonstrated knowledge of multiple applicable techniques such as: HPLC, UV-Vis, FT-IR, NIR, Raman Spectroscopy methods, color and appearance tests, hardness testing, pH measuremetns, compendial methods, and wet chemistry techniques.

  • Proficient in Microsoft Excel and Word

  • Proven ability to interpret data by performing trend analysis 

  • Proven ability in technical writing skills

  • Ability to independently optimize analytical methods 

  • Proven problem solving and troubleshooting abilities 

  • Good written and oral communication skills 

  • Time management and project management skills 

  • 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, including infectious agents, 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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