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Research and Development Formulator
3 months ago
JOB RESPONSIBILITIES:
- Formulates and develop various OSD products. Develop laboratory and manufacturing process for OSD products.
- Ensures seamless technology transfer of processes between pilot scale and into final commercial manufacturing. Oversees the execution of pilot to commercial scale manufacturing process.
- Design and optimize various OSD formulation and filling operations, blending, tableting, coating and bottle filling.
- Communicate with material, component and equipment vendors to source equipment and project-specific materials.
- Prepare the technical content in regulatory documents, manufacturing instructions, and SOPs.
Perform any other related duties as required or assigned.
REQUIREMENTS:
- Bachelor of Science degree or higher in Pharmaceutical Sciences, Chemistry, Biology or equivalent with a minimum of 3 years of pharmaceutical industry experience in formulation development, process development and/or manufacturing required.
- Prior experience in formulation development activities in an FDA-regulated environment.
- Solid understanding of pharmaceutical dosage forms, especially OSD (extensive hands-on process experience a plus).
- Thorough understanding of Good Manufacturing Practices (GMP) desired.
- Experience with Microsoft software products including Outlook, Excel, and Word.
While performing the functions of this job, the employee is regularly required to sit, use hands to finger, handle, or feel, reach with hands and arms, talk or hear; and occasionally required to stand, walk, climb or balance, stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and the ability to adjust focus. The employee is occasionally exposed to work near moving mechanical parts.
- 4-day work week
- Comprehensive health insurance plans (medical, dental, and vision)
- Generous Paid Time Off (PTO) plan and company-paid holidays
- 401k with Employer match
- Company-sponsored Group Life, Short- and Long-Term Disability Insurance