Arun Punnen

Senior analytical, inquisitive Pharmaceutical Scientist with management and supervision experience in cGMP compliant Pharmaceutical Analytical Research & Development (AR&D), Quality Control and compliance department (QC &QA), Stability, pre-formulation laboratories. Expert in method development, transfer, validations, and reverse engineering. Adept at communicating via technical writing and presentations across disciplines including product formulation development, cleaning, stability, calibration, compliance, and regulatory affairs departments.

Performed reviews, batch reviewing, product releasing, and technical writing.

Experience in training, mentoring, analytical troubleshooting.

Experience in setting up physical & chemical lab in different companies.

Associate Director - Agno Pharma (Particle Sciences) - 3894 Courtney Street, PA.18017

(2020-04 - 2026-01)

Managed Analytical product development, for complex Injectables, implant devices and nano suspensions. Managed direct reports, for analytical method development validations, transfer, and product development support. Co-coordinated projects in manufacturing sites, both domestic and international. Project management, client interaction, and budgeting.

AR&D Technical Leader - Perrigo Pharmaceuticals - Bronx, NY

(2019-08 - 2020-03)

Lead Analytical product development and product life cycle management, for Skincare, and inhalation products. Managed analytical method development, validations, transfer, Invitro (IVRT) permeation studies and verification studies. Co-coordinated projects, wrote annual product report,

Manager - Albany Molecular Research Inc.

(2017-08 - 2019-07)

• Lead Analytical product development, for Injectables, peptides, suspensions, and Ophthalmic products. Managed direct reports, for analytical method development validations, transfer, and product development support. Coordinated projects in manufacturing sites, both domestic and international. Planned, led projects, and coordinated with clients & other departments. Managed product cycle time using Gnat charts. Wrote protocol and test methods.
• Interacted with QA, RA & EHS. Presented analytical summary in Client and internal meetings. Participated in kickoff project meetings, outside vendor meetings. Performed managerial duties including scheduling of work, resource allocation, cGMP training, review of analytical data. Managed weekly internal meeting and annual personal reviews. Coordinated drug product submission, CMC sections writing, answering FDA deficiency letter.
• Performed Stability programs gap analysis, used quality management system (QMS) for CAPA, identified attributes and CQA. Have participated in inter departmental assessments, initiated change controls using GxP software.

ARD Principal Scientist - TEVA/ Barr Laboratories - Pomona, NY

(2004-08 - 2017-08)

• Team Lead and project management for product development, analytical method development validation and transfer for Capsules, Tablets, injectables, creams, and transdermal. Pioneer Scientist to lead, setup lab for transdermal analytical activities. Initiated transdermal-related analytical procedures, SOP's. etc., gaining expertise by training at several vendor sites and contract labs. Waters Empower System Managing (Subject matter Expert) for ARD and QC, Subject matter expert for electronic labo
• Supported stability programs for development studies, submission, approval stages and lifetime management. Co-ordinated studies writing protocols considering different region requirements, bracketing samples for efficient managing of stability studies saving time and space. Monitored master stability programs for stability co-ordination, sample pull, data entry, trend analysis. Participated in OOS/OOT investigations and contributed for CTD dossiers.
• Have supported programs globally, sample transportation with proper stability condition packaging, managing data. Established key performance indicators (KPIs) and metrics to track compliance improvements and identify any emerging gaps or risks. Periodic reassessment of the gap assessment process itself ensures its ongoing relevance and alignment with changing regulations and industry expectations.

AR&D Supervisor /QA Auditor - Agis Group Laboratory Inc - Bronx, NY

(2001-10 - 2004-07)

Worked on pre-formulation, reverse engineering, vendor qualifications of raw materials, characterization of APIs for primary and secondary standards qualifications. House standard paper works, Monograph preparations, and pre-validation and validation studies. Raw material monograph and validation protocol preparation.

Worked a year in QA department, releasing drug products, conducted periodical auditing in various departments. Wrote sections in annual product report. Have used QMS system for CAPA

AR&D Supervisor/Assistant Supervisor/QC Chemist - Agis Group Laboratory Inc - Bronx, NY (Clay-Park)

(1993-03 - 2000-05)

Analytical method development and qualification of API, preservatives, antioxidants, stability indicating methods for related impurities, degradation products, cleaning validations, and dissolution profile studies. Validation of methods, Preparation of SOP's, applied safety procedures adhering to ICH guidelines, USP, BP, FCC. Standard inventory and record keeping. Preparation of Protocols, reports, procedures following FDA regulations.

Systems Technology specialist - Columbia University (Health Sciences) - NY, NY

(2000-05 - 2001-09)

Networking and security. Configured and Optimized Server/Client Operating systems. Maintained user accounts on NetWare server and NT server. Configuration of e-mail clients, accounts on UNIX server and Exchange server. Maintain internal website and invoice database.

MS - Industrial Pharmacy - Long Island University (2009)

Network Engineering and Data Processing - Chubb Institute (1998)

Diploma - Computers in Office Management - National Open University (1991)

MS - Postgraduate Computer Applications - Trichur Engineering and research Center (1990)

MS - Applied Chemistry - Mahatma Gandhi University (1987)

MBA - Executive certificate - Long Island University, Rockland (2013)