Generic Examples of Former Customer Assignments

MedTech customer assignments:

 

  • Formulation of various biocompatible inks, adhesives, coatings, and wound dressings

  • Part in developing GMP manufacture processes for a biocompatible imjectable hydrogel, prototyping of key processes, and specifying user requirement (URS) for the customer

  • Data review and technical writing related to IPR and patent applications

Biotech and Pharma customer assignments

 

  • Research on using polymeric pH sensitive nanoparticles for targeted delivery of a proprietary lipophilic pro-drug

  • Part of developing a cells encapsulation process using polyelectrolytes, and stress-testing of capsules formed for their injectability through biopsy needles

  • Pharmaceutical formulation and in-vitro dissolution and drug partition tests for a new rectal dosage form

QA and CMC assignments

 

  • For an immediate release low-dose tablet formulation a control plan of blending was developed using an Quality by Design (QbD) approach

  • A risk assessment was made to go from a single-strain to multi-purpose GMP contract manufacturing identifying preventive measures to cross contamination and mix up

  • Joined an engineering team for developing SAT/FAT protocols for critical processing equipment, development of validation protocols, and review of data obtained

  • Technical writing for 510(k)/PMA applications, and input for drug CTD, deficiency notes, and post-approval change notification