Product Innovation Scientist

1 month ago


Paragon, Indiana, United States Particle Dynamics Full time
Job Overview

Have you ever considered how your daily work can significantly influence the health and well-being of individuals globally? If this resonates with you, we may have an ideal opportunity.

At Particle Dynamics, we specialize in the creation of pharmaceutical, nutraceutical, and over-the-counter products aimed at enhancing consumer health worldwide. We provide opportunities for growth and training for those seeking a refreshing change from large-scale manufacturing environments. Here’s what sets us apart:

  • We maintain a close-knit team environment, fostering a familial atmosphere among employees.
  • Our employees enjoy immediate paid time off, eliminating waiting periods.
  • We offer a competitive benefits package, with coverage commencing on the first of the month following your hire date.
  • Our compensation is highly competitive, rewarding experience and high performance.
  • As a pharmaceutical manufacturer, all our production and packaging lines are climate-controlled.
  • We promote a healthy work/life balance, ensuring our employees are not overworked.

This position operates during the day and reports directly to the VP of Technical Operations.

Key Responsibilities:

  • Lead formulation and process development initiatives from initial stages through to full-scale production.
  • Participate in feasibility discussions to provide innovative solutions for customer challenges.
  • Collaborate with the business development team to draft the technical sections of product development proposals.
  • Facilitate technical updates on development projects with client representatives.
  • Establish and oversee project timelines, either independently or as a project team leader.
  • Design and implement stability protocols for new product developments as necessary.
  • Work alongside customers and business development to showcase Particle Dynamics' capabilities and align with customer needs.
  • Assist the commercial team in formulating business cases and cost estimates for new products.
  • Plan and coordinate risk analysis, quality-by-design, process development, method development, and technical transfer activities for new products to ensure compliance with quality, cost, and manufacturability standards.
  • Draft manufacturing batch records, experimental protocols, process development reports, and other necessary documentation.
  • Provide technical support to operations and quality assurance for the validation and launch of new and reformulated products.
  • Offer technical assistance for troubleshooting process issues and enhancing product performance.
  • Engage in method development, process optimization, and technology transfer activities.
  • Support colleagues within the PPIC group.
  • Complete projects within designated timelines while adhering to applicable cGMPs, GLPs, and company policies.
  • Participate in the procurement and qualification of new equipment for research and development.
  • Assist the Supply Chain in selecting and qualifying new raw materials.

Qualifications:

  • Comprehensive knowledge of pharmaceutical, nutraceutical, and food compliance regulations.
  • Strong analytical and problem-solving capabilities.
  • Project management proficiency.
  • Excellent verbal and written communication skills.
  • Proven technical writing experience.
  • Team-oriented mindset.
  • Commitment to staying updated on manufacturing technologies through professional development.
  • Proficient in MS Office, Excel, Word, MS Project, Visio, Minitab, and related software.

Education and Experience:

  • Bachelor's degree in Chemistry or a related discipline.
  • A minimum of 5 years of experience in product/formulation development within GMP environments is preferred (10+ years for senior roles).
  • Professional experience in product development.
  • Prior experience in drafting SOPs, batch records, and work instructions.
  • Experience with qualifications and validation is highly preferred.
  • Experience in customer technical support and troubleshooting.
  • Customer-facing product development experience is advantageous.
  • Experience in project management within a collaborative team setting.

Benefits:

  • Health, dental, vision, STD/LTD, and life insurance effective from the first day of the month following hire.
  • 401k matching program with immediate vesting.
  • Eligible for 120 hours of vacation, 40 hours of sick leave, and 16 hours of personal time annually.
  • Uniforms, safety shoes, and safety glasses provided.
  • Paid holidays available upon hire.


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