Dubai, United Arab Emirates
Anuj Bansal B.Pharm, MTech
EXPERT IN: Formulation & Product Development Novel Drug Delivery Technology Transfer GAP Analysis OSD & Parenterals Biosimilars Formulation NDA’s 505 B(2) & ANDA QbD Project Management I am working as a Senior Formulation Scientist & Technology Transfer with over 10 years of extensive experience in Pharmaceutical & Biotechnology Industry. My core knowledge & experience is in the field of Advance Drug Delivery, Formulation Development, Technology Transfer, Project Management & Product launching in USA, Europe, MENA & ROW Professional Experience
Senior Formulation Scientist /Technology Transfer
Pharmax Pharmaceuticals FZ LLC - Dubai UAE February 2018 to till date
Formulation & development of Solid oral dosage forms of Ezetimibe, Perindopril, Bisoprolol, Etoricoxib, Rosuvastatin, Atorvastatin, Candesartan, Candesartan+HCT, Gliclazide + Metformin Tablets etc.
Preparation of PDR & Identify all the Quality Target Product Profile, critical quality attributes, critical process parameters for both method & process transfer with an established range
Preparation of User Requirement Specification (URS) form of equipment’s used in the OSD facility.
Preparation of GAP assessment documents (CRO’s & Pharmax site) for technology transfer products.
Coordinate with supplier for procurement of API & excipient and availability of equipment and tooling, change parts for the primary packing required for the method & process transfer.
Expertise in the BOSCH HUTTLIN granulation suite (High shear Mixer Granulation with Top impeller). Formulation Scientist & Technology Transfer (3 years 10 months) Gulf Pharmaceutical Industries (JULPHAR), RAK, UAE June 2014 February 2018
Formulation & development of OSD forms (Paracetamol tablet combination products, Atorvastatin tablet, Rosuvastatin tablet, Ibuprofen tablet and its analogues, parenteral products (Paracetamol & Linezolid injection).
Formulation & development of Biosimilar Products Insulin Rapid Acting, Insulin intermediate, Insulin 30/70 & Glargine long acting) & Darbepoetin alfa injection (Analytical method development & validation of Insulin analogues)
R&D documentation relating to formulas & processes to acquire the technical knowledge of products being transferred or introduced (NDA’s 505 B(2), ANDA, and product development report).
Technology transfer and scale-up of batches from lab to commercial scale
Preparation of pilot and scale-up manufacturing documentation suitable for stability studies Senior Executive – Advanced Drug Delivery Research (4 years 10 months) Panacea Biotec Limited, India August 2009 – June 2014 Vertical growth from Project Trainee (2009-10) to Research Associate (2010-2013) to Senior Research Executive (2013-2014)
Development of IR, ER tablet dosage forms, CR suspension by using Wurster Coating machine by Paam Glatt (Bottom Spray for pellet coating) for domestic market, regulatory market 505 B(2), ANDA & topical gel semisolid dosage forms
Working knowledge and application of Quality by Design (QbD) Professional Profile Formulation Scientist with Technology Transfer Expertise - 10 yrs experience 2
Expertise developed on advanced pellets, fluid-bed & pelletization by extrusion & spheronization technology & systems required for NDA’s for global markets
Four products launched in India and One product launched in US & EUROPE
Successfully completed exhibit batches on oral dosage forms for US, EUROPE & ROW Job Responsibilities
Research & Development
Pre-formulation/formulation development and manufacturing processes for dosage forms (solid orals conventional/CR, IR, oral CR suspension, topical/transdermal gel)
Involved in generation of specification for product release or finished product specification
Improved solubility of NCE formulation & toxicity studies Process Development
Formulation & development of solid oral dosage forms (CR suspensions, modified ER & Bilayer tablets)
Coordination with RA department in filing ANDAs, addressing FDA deficiencies & trouble shooting Projects Documentation
Master production record of exhibit batch, intended commercial batch, Master formula card & technical direction
Preparation of In-process, Finished product & Shelf life specification
Optimization, product development & scale-up reports including stability & sampling protocols Validation Batches
Preparation of process validation protocols & its execution for the first three commercial batches
Execution of validation batches for US Market & preparation of process validation report Instrumentation Skills
Practical experience with instruments at shop floor: Rapid & High shear mixer granulator (Huttlin BOSCH), Vibrator shifter, Rapid & fluid bed dryer, Wurster fluid-bed coater, Conta blender, Extruder, Spheronizer, Oscillator granulator, Tablet compression & coating machine, Tap density & Hardness tester, Turbo sifter cum multimill, Roll compactor, Lyophilizer, Dissolution & disintegration apparatus.
Analytical: HPLC, HPTLC, UV/visible spectrophotometer, Multi-plate reader
Pharmaceutical: Phase contrast, scanning & transmission electron, atomic force microscopy, particle size analyzer, Malvern zeta sizer
Education & Credentials
2010 Masters in Nanosciences & Nanotechnology, Kurukshetra University, Kurukshetra, Haryana, India 2008 Bachelor of Pharmacy, Guru Gobind Singh College of Pharmacy, Yamuna Nagar, Haryana, India 2009 Graduate Aptitude Test in Engineering - 98.87 percentile (IIT Roorkee) Personal Details
Date of Birth July 23 1986 Visa Status UAE Employment/Resident
Nationaly Indian Language Known English, Hindi, Punjabi References
Available on Request