Scientist, GMP Analytical

MSD•Rahway, NJ
•Onsite

About The Position

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. Our Company Animal Health, a global, research-driven company that develops, manufactures, and markets a broad range of veterinary medicines and services, is seeking a GMP Analytical Scientist for a newly-established GMP laboratory within our R&D facility in New Jersey. This Scientist will support the progression of molecules throughout the development process, helping to transform drug candidates into marketed products for our company Animal Health, a company whose products enable pets and people to enjoy their time together and help keep livestock healthy to ensure a safe, sustainable, and high-quality food supply. The professional in this position will: Execute GMP method validation for active pharmaceutical ingredients (APIs), excipients, and formulated drug products (e.g., tablets, topicals, solutions, implants). Support a pilot manufacturing plant through the testing of APIs, excipients, packaging materials, and cleaning samples. Work closely with R&D project leads to assess project needs, timelines, and prioritization. Understand GMP processes and work in adherence to SOPs and method protocols. Maintain high-quality documentation and data integrity, analyze and interpret data, and prepare technical reports, with the support of senior scientists and managers in the organization. Support the analytical development of high-priority drug candidates. The candidate will be trained to develop excellent laboratory skills and a solid understanding of analytical and physical chemistry. Techniques often used by persons in this position include chromatography (e.g., HPLC, GC), dissolution, physical characterizations (e.g., particle size analysis, viscometry, density), and general/wet chemistry methods. This position requires the ability to work well in a highly collaborative environment as well as excellent oral and written communication skills.

Requirements

  • Bachelor's degree in Chemistry, Pharmacy, or other scientific discipline
  • Minimum 1 year of previous pharmaceutical experience.
  • Strong technical skills and a proficiency in analytical laboratory techniques.
  • Some work experience in a GMP environment and an understanding of GMP processes and SOP governance.
  • Ability to work under the general direction of a laboratory supervisor.

Nice To Haves

  • Strong oral and written communication skills, including experience authoring technical documents.
  • Demonstrated knowledge of multiple analytical techniques such as: HPLC, GC, Dissolution, Karl Fischer, Particle size, Viscometry, Texture Analysis, Auto titration, etc.
  • Familiarization with USP and Ph. Eur. Monographs.
  • Familiarization with software validation (SDLC)
  • Attention to detail, customer focus, and continuous improvement.
  • Personal drive for results and a demonstrated history of achievement in a pharmaceutical laboratory environment.

Responsibilities

  • Execute GMP method validation for active pharmaceutical ingredients (APIs), excipients, and formulated drug products (e.g., tablets, topicals, solutions, implants).
  • Support a pilot manufacturing plant through the testing of APIs, excipients, packaging materials, and cleaning samples.
  • Work closely with R&D project leads to assess project needs, timelines, and prioritization.
  • Understand GMP processes and work in adherence to SOPs and method protocols.
  • Maintain high-quality documentation and data integrity, analyze and interpret data, and prepare technical reports, with the support of senior scientists and managers in the organization.
  • Support the analytical development of high-priority drug candidates.
  • Develop excellent laboratory skills and a solid understanding of analytical and physical chemistry.
  • Utilize techniques such as chromatography (e.g., HPLC, GC), dissolution, physical characterizations (e.g., particle size analysis, viscometry, density), and general/wet chemistry methods.
  • Work well in a highly collaborative environment.
  • Communicate effectively orally and in writing.

Benefits

  • medical, dental, vision healthcare and other insurance benefits (for employee and family)
  • retirement benefits, including 401(k)
  • paid holidays
  • vacation
  • compassionate and sick days
  • annual bonus
  • long-term incentive
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