BioKey Inc.

BioKey Inc.BioKey Inc.BioKey Inc.

BioKey Inc.

BioKey Inc.BioKey Inc.BioKey Inc.
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A CDMO Service Provider for Nutritional And Pharmaceutical Products

A CDMO Service Provider for Nutritional And Pharmaceutical ProductsA CDMO Service Provider for Nutritional And Pharmaceutical ProductsA CDMO Service Provider for Nutritional And Pharmaceutical Products

(510)-668-0881

A CDMO Service Provider for Nutritional And Pharmaceutical Products

A CDMO Service Provider for Nutritional And Pharmaceutical ProductsA CDMO Service Provider for Nutritional And Pharmaceutical ProductsA CDMO Service Provider for Nutritional And Pharmaceutical Products

(510)-668-0881

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

Contact Us

We love our customers, so feel free to visit during normal business hours.

BioKey, Inc

44370 Old Warm Springs Boulevard, Fremont, California 94538, United States

Phone +1(510)668-0881

Please contact us for free consultation!

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