DHAKSHNAMOORTHY VELLINGIRI (Dhakshna)

Skills acquired involve new product development from bench scale to commercial scale

Developing complex, robust, stable, and bio-equivalent formulations by facing patent challenges

which includes but not limited to below routine workflow…

Molecule selection-feasibility assessment—pre formulation studies for API/process/excipient

selection—reference product reverse engineering—prototype formula & process using feasible

DOE tools with technical risk assessment, identification of CQA's and CMA's to create design

space—Dissolution mapping—stability studies —packing material selection—tech transfer to

pilot/ commercial scales-preparation of dossiers for various regulatory markets—validation with

overall product lifecycle management by following QBD principles in collaboration with key

stake holders like RA, QA, AD ct,

Expertise in preparation of regulatory dossiers, successful completion of queries, deficiencies,

market complaints in timely manner and mentoring team members

Experienced with setting up new OSD lab and pilot plant for two major organizations

Hands-on experience in development of conventional, novel and complex generic solid oral

dosage forms like chewable, ODT, MUPS, DR & ER Tablets, soft gel/hard capsules, dry powder

for oral suspensions, syrups and liquids Expertise in technologies like taste masking, Nano

milling, solid dispersion, fusion, melt extrusion and spray drying Experience in handling 505

(b) 2 & para IV strategies

Capable of handling cephalosporin molecules with 4 years of experience

Well versed with creation and review of literature/patent search reports, TT documents, stability protocols, BMR's, SOP's, GMP and EHS policies, guidelines, and regulations

Digitally capable of handling coloboration and research tools like ELN, Power BI tools, Design Expert, Minitab, Mirro Ect,