Summary of the Job

The Technology Transfer Officer will help with the development and transfer of pharmaceutical products.

They will work on validating analytical methods, making sure quality, and moving technology from formulation development to manufacturing.

The job includes making sure that pharmaceutical rules and quality standards are followed when doing dissolution studies, cleaning validation, stability testing, and analytical method transfers.

Main Duties

1. Testing and Validating Analytically

Do comparative dissolution studies on test products and reference comparator products to make sure they are pharmaceutically equivalent.
Validate and verify analytical methods and write detailed reports.
Validate cleaning for new products made at Formulation Development.
Transfer analytical methods when products move from Formulation Development to Manufacturing.
Do accelerated and long-term stability studies with detailed reporting.
Profile impurities in drug substances, including finding and measuring them.

2. Help with Product Development

Help Formulation Development Officers come up with analytical methods like spectroscopy, chromatography, and dissolution.
Help with formulation development experiments, analyzing the results, and writing reports.
Do biopharmaceutical characterization experiments to help with drug product development.
Test new analytical techniques in pre-formulation sciences, automated workflows, and biorelevant testing.
Work on experiments and data analysis for different pharmaceutical formulations.

3. Systems and Documents for Quality

Make and check specifications in the SAP system.
Use the ERP System/SAP to make specifications and the Trackwise system to handle deviations and complaints.
Write Standard Operating Procedures (SOPs), FMEAs, protocols, and other technical documents.
Make sure that Quality Management Systems and pharmaceutical rules are followed.

4. Following the Rules and Coming Up with New Ideas

Make sure that pharmaceutical rules, such as Good Manufacturing Practices (GMP) and ICH principles, are followed.
Show creativity and innovation that meets the demands of the business.
Be able to work shift programs as needed by the business.

Experience and Qualifications

Important Requirements

Qualification	Description
Education	A bachelor's degree in chemistry, chemical engineering, industrial chemistry, science technology (chemistry), or a similar science discipline
Experience	At least three years of experience in quality control in a factory or a well-known lab
Knowledge	Knowledge of pharmaceutical rules (GMP, ICH recommendations)
Skills	Knowledge of Excel formulas and PowerPoint presentations
Analytical Skills	Experience with analytical tools and data visualization (Pareto Charts, Waterfall, Pie Charts, Bar Charts, Line Charts)
Personal Skills	Strong skills in observation, creativity, and innovation

Qualifications that are Good to Have

Qualification	Description
Certification	A certificate in quality management or quality assurance
System Experience	Experience with SAP or other ERP systems
Knowledge	Knowledge of Trackwise or other quality management systems