Associate Scientist AR&D

Perrigouk; Allegan Township (MI); On-site; USD 70,000 - 95,000; Full time

Job summary

Perrigo's Allegan, Michigan-based Analytical Research and Development team seeks a talented colleague for its New Product Development group. You will develop, validate and transfer analytical methods (HPLC/UPLC/GC, dissolution) for oral and nasal drug products, with both hands-on lab work and mentoring responsibilities.

You’ll contribute across the product lifecycle from concept to commercial production in a fast-paced environment.

Qualifications

• Bachelor’s degree with 2–4+ years of cGMP/cGLP laboratory experience
• Master’s degree with 1–2+ years of cGMP/cGLP laboratory experience
• PhD in Chemistry or Pharmaceutical Sciences required or strongly preferred
• Experience with analytical method validation and transfer (IQ/OQ/PQ) and regulatory expectations

Responsibilities

• Develop, validate and transfer analytical methods for oral and nasal drug products (HPLC, UPLC, GC, dissolution)
• Perform physical and chemical testing on samples with attention to detail
• Document analyses and communicate results through reports and presentations
• Mentor/training of colleagues and cross-functional collaboration
• Lead/participate in cross-functional project teams and manage multiple projects

Skills

Analytical method development

Data analysis

Experiment execution

Documentation

Mentoring

Project management

Communication

Team collaboration

Education

Bachelor's degree in Chemistry or Pharmaceutical Sciences

Master's degree in Chemistry or Pharmaceutical Sciences

PhD in Chemistry or Pharmaceutical Sciences

Tools

HPLC

UPLC

GC

Dissolution

Waters Empower

Job description

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Based in Allegan, Michigan the Perrigo Analytical Research and Development team, specializing in solid and liquid Over-the-Counter (OTC) product development, is looking to add a talented colleague to our New Product Development team. Our focus is on the development of analytical methods for small molecules in support of research and characterization of new and reformulated drug products. Chief techniques include HPLC/UPLC-UV stability-indicating methods with various separation chemistries.

The Professional in this role will be responsible for development of assay, impurities, dissolution, and physical characterization methods for oral and nasal drug products. There is an expectation of both direct hands-on laboratory work as well as mentoring/training of colleagues.

This is a great career move for someone who wants to be involved in the entire drug product life cycle, participating from initial concept to commercial production, with opportunities to contribute to a successful global pharmaceutical business focused on Quality, Affordable Self-Care Products.

Scope of the Role

• Perform physical and chemical testing on raw materials, in-process and finished product samples with superior attention to detail and a focus on operational excellence.


• Clearly document and precisely execute analyses and experiments of moderate to high complexity. Analyze and properly interpret data, prepare reports, give presentations, or author other technical communications as necessary.


• Develop, validate and transfer analytical methods of varying complexity on the following platforms: HPLC, UPLC, GC, dissolution, and others as needed.


• Collaborate effectively with other departments and/or sites on project deliverables.


• Participate in/lead cross-functional teams at project-related meetings and technical discussions.


• Carry forward multiple concurrent projects and significantly contribute to product knowledge.


• Proficiency with a variety of analytical instruments for physical and chemical analyses, including but not limited to: HPLC, UPLC, GC, Dissolution.


• Ability to develop, trouble-shoot, and validate complex or innovative analytical methods which are robust and reliable, with minimal supervision, in a fast-paced and dynamic environment.


• Familiarity with calibration, maintenance, installation, and qualification of lab equipment.


• A working understanding of chemical structure at the molecular level.


• Judgement to make clear and concise decisions regarding project execution. Strong organizational, communication, and project management skills are a must.


• Passion for a team-oriented culture focused on shared ownership and responsibility.


• Familiarity with a variety of compendial references including the United States and European Pharmacopeia, as well as FDA Guidances and ICH Guidelines related to analytical methods validation and drug product development.


• Experience with statistical analyses of data and Design of Experiment concepts.


• Waters Empower software experience highly desired.

Experience Required

The skills required for this role are normally acquired through completion of:

• Bachelor’s degree in Chemistry or Pharmaceutical Sciences with 2-4 or more years of cGMP or cGLP laboratoryexperience, or


• Master's degree in Chemistry or Pharmaceutical Sciences with 1-2 or more years of experience in a cGMP or cGLP laboratory, or


• PhD degree in Chemistry or Pharmaceutical Sciences