Services
Product Development
- Formulation Development for Oral and Topical Semi-Solid Dosage Forms
- Controlled Release Delivery of API
- Improving API Stability
- Tablet coating
- Taste/Odor Masking
- Optimizing Production Cost
Analytical Services
- Method Development and Validation
- Degradation Studies
- Dissolution Method Development
- Cleaning Validation
- Raw Material Testing
Regulatory Support
Electronic Submissions (eCTDs)
- Paper Applications (CTD)
- Structured Product Labeling (SPL)
- Establishment Registration
- Drug Listing
- U.S. Agent Services
CGMP Manufacturing Services for Nutritional and Pharmaceutical products
- API Compounding and Fill Into Capsules
- Manual and Automated Encapsulation
- Wet Granulation/Tray or Fluidbed Drying
- Tablet Compression and Coating
- Packaging of CTM for IND, NDA, or ANDA Clinical Studies
- Stability Studies
- Topical Dosage Form (Semi-Solid, and Liquids)
- GMP Suites
CAREERS
1. JOB TITLE: RESEARCH ASSISTANT II, PHARMACEUTICAL DEVELOPMENT & MANUFACTURING
DESCRIPTION:
This position reports to the Manager, Product Development and supports all R&D and GMP operations, including facility maintenance at BioKey, Inc.
Essential duties and responsibilities include, but are not limited to, the following:
- Perform GMP operations
- Perform R&D operations
- Maintain cleanliness and sanitation of the GMP facility
- Maintain cleanliness and sanitation of the R&D facility
- Maintain cleanliness and sanitation of equipment
- Maintain cleanliness and sanitation of the warehouse and common areas
2. JOB TITLE: RESEARCH ASSOCIATE II, QUALITY CONTROL & ANALYTICAL SERVICES
DESCRIPTION:
The Analytical Associate would report directly to the Supervisor. The individual supports the QC/AR Supervisor in all quality control and analytical activities.
Duties and responsibilities include, but are not limited to, the following:
- Coordinating contract service projects - method transfer, method validation, and reports
- SOP preparation in compliance with cGMP operations and FDA regulations
- HPLC assay development for pharmaceutical products and raw materials
- Perform laboratory analytical tests including HPLC, FTIR, dissolution, cleaning validation, and regular stability testing