Sunil Acharya

About Sunil Acharya

Accomplished pharmaceutical development professional with 12+ years of progressive experience driving innovation in generic formulation development for regulated markets like USFDA, EMA, MHRA.Proven track record in end to end product lifecycle management from QbD driven formulation development to scale up, technology transfer, Exhibit/Submission batch manufacturing and regulatory submissions. Strong track record of successfully leading complex ANDA submissions, FTF (first to file), CGT opportunities and 505(b)(2) pathways from concept to commercialization.I work closely with both R&D and manufacturing teams to ensure smooth product handovers while maintaining stability, dissolution and bioequivalence readiness, nitrosamine compliant and regulatory compliance.Advanced Manufacturing Technologies: Hands on experience in Wurster coating, fluid bed and high shear granulation, extrusion and spheronization, roller compaction, direct compression, and drug layer/functional tablet coating systems for solid oral dosage forms.Analytical intelligence: Stability studies (ICH), MMD and bio relevant dissolution (IVIVC), Impurity profiling, Bioequivalence interpretation.Regulatory Excellence: ANDA and 505(b)(2) submissions, PDR and Technical dossier support and CRL/DRL query resolution and Nitrosamine risk assessment (EMA/FDA)Proficient in Scale Up and Technology Transfer: CPP/CQA identification, Lab to plant scale transitions/ Manufacturing readiness/ Exhibit batch production/ cross functional collaboration to deliver projects ahead of scheduleHands on experience with equipment qualification(FAT,IQ,OQ,PQ), technical documentation (BOM, MFR, BMR, BPR), PDR writing and QMS platform (Master Control, Veeva Vault, Trackwise).Always learning and upgrading: Certified in Computational Pharmaceutics((IVIVC/PBPK modeling/ Gastroplus/ BE safe space/ Convolution/Deconvolution) from NIPER Mohali to stay current with new pharma tools and trends. Currently pursuing a PGDM in Executive Modern Project Management to to strengthen leadership and delivery skills.

Experience

1. Assistant Manager

   Par Health

   Aug 2022 — Present · Mumbai, IN

   Executed formulation development projects for Immediate Release (IR), Delayed Release (DR), and Extended Release (ER) tablets and capsules targeting the USA regulated market.Applied a Quality by Design (QbD) framework across development activities, including prototype design, process optimization, risk assessment, and evaluation of critical process parameters (CPPs) and CMAs.Led the scale-up of Wurster coating technology from R&D to plant scale, optimizing process parameters and enabling smooth and compliant technology transfer.Played a key role in establishing a new Formulation & Development laboratory, including equipment selection, qualification (FAT & PQ), and readiness in line with regulatory and cGMP requirements.Well versed with quality management systems including MasterControl, Veeva Vault QMS, and TrackWise to ensure data integrity, compliance, and efficient documentation.Key AchievementsSuccessfully progressed products from laboratory development through scale-up and exhibit batches for IR, DR, and ER tablets and capsules, contributing to ANDA and CGT approvals from the US FDA.Executed submission batches of extended-release capsules in Wurster(bottom spray technology), optimizing batch calculations and functional coating parameters to achieve uniform coating and resolve static-related process challenges.Executed submission batches of drug-layered tablets, ensuring robust content uniformity (CU) and process controls in line with regulatory expectations.Led end to end development of immediate, delayedand extended-release tablets, executed plant scale submission batches while optimizing critical process parameters in granulation and coating to ensure robust and reproducible manufacturing processes.

Education

• National Institute of Pharmaceutical Education and Research (NIPER) ,SAS NAGAR , Mohali

  Computational Pharmaceutics

• S.C.B. Medical College, Cuttack

  Diploma in Pharmacy, Pharmacy

  2006 — 2008

• Siksha 'O'​ Anusandhan University

  Master of Pharmacy, Pharmaceutics

  2011 — 2013

• Siksha 'O'​ Anusandhan University

  Bachelor of Pharmacy

  2008 — 2011

• MIT School of Distance Education

  Postgraduate Degree, Project Management