Asif Ali

About Asif Ali

I am a methodical, ambitious and always-evolving researcher with proven leadership skills. I am an adaptive pharmaceutical professional with versatile experience on process development and technology transfer of various dosage forms, such as sterile injectable and ophthalmics, topicals and oral solids. I bring diverse research and industrial experience and cover a broad spectrum of areas, such as formulation, processes development, analytics, drug delivery, and PK/PD evaluation. I enjoy collaborating with scientists from different fields and looking to expand my skill set and solve new challenges.

Experience

1. Scientist

   Alexion Pharmaceuticals, Inc.

   Jan 2022 — Present · New Haven, CT, US

   Leading formulation and process development of multiple injectable biologics drug products for rare disease indications across different Phase of Lifecycle:• Design, execute, and oversee formulation development for biologic products, from First-In-Human (FIH) studies to formulation optimization for Phase 2/3 trials.• Perform advanced biophysical and protein quality characterization (including SEC-UPLC, CE-SDS, CIEF, DLS, DSC, HIAC, and MFI) to assess drug stability.• Strategize and manage all aspects of drug product manufacturing process development for biologics, from early concept through commercialization, with expertise in bulk freeze/thaw, liquid mixing, sterile filtration, container filling, and cold chain management.• Support reformulation projects and the development of patient-centric drug delivery systems for marketed biologics to drive product life-cycle innovation.• Collaborate closely with cross-functional Chemistry, Manufacturing, and Controls (CMC) teams to create and execute project plans, manage budgets, and adhere to timelines.• Author technical documents such as tech-transfer manuals, process development reports, master manufacturing records, and regulatory submission materials.• Lead technology transfer of manufacturing processes to both domestic and international sites, designing and executing at-scale process studies, and ensuring project schedule adherence.• Advance in-house process capabilities while staying up-to-date on evolving technologies and current regulatory guidelines.• Mentor and train colleagues within the organization, including peers, associates, and interns.

Education

• Jadavpur University

  M.Pharm, Pharmaceutical Sciences

  2012 — 2014

• NSHM College of Pharmaceutical Technology

  B.Pharm, Pharmaceutical Sciences, Pharmacology

  2005 — 2009

• Long Island University

  Doctor of Philosophy (Ph.D.), Pharmaceutics and Drug Design

  2015

Skills

• Formulation
• Formulation Scale-Up
• Standard Operating Procedure (Sop)
• Rt-Pcr
• Animal Handling
• Pharmaceutical Industry
• Sop
• Pharmaceutical Research
• Validation
• Electrocardiography Ecg
• Drug Delivery
• Column Chromatography
• Glp
• Hplc
• Quality System
• Product Development
• Technology Transfer
• In Vitro
• High-Performance Liquid Chromatography (Hplc)
• Gmp
• Pharmaceutics
• Quality Assurance
• Pharmacokinetics
• Regulatory Affairs
• Pharmacology