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505-207-7740

US. Cit. // N.J. RESIDENT // NO RELOCATION AVAILABILITY
MS Industrial Pharmacy, MS Organic Chemistry, BS Biology //
Rx Oral solid dose, non-sterile liquids, OTCs //

WORK HISTORY:

10/2012 – 12/2013 Scientist (Technical R&D).
Achievement: Actively involve pilot plant activity includes Development support for manufacturing of Oral solid and liquid products using different technology.

• Provide technical input and partnership with formulation scientists for the manufacturing of Oral solid and liquid drug products.
• Supported technology transfer (scale-up) of New Products and Process Improvement from Development to clinical manufacturing.
• Complete Change Management records, keep current with all training GMP and Safety training
• Prepared and reviewed documents to support technical project including master batch records, protocols, and technical reports.
• Collaborates with team members to facilitate the deliveries of DS and/or DP.
• Optimize new product development and scale-up manufacturing process if required
• Actively participate in project team /meeting /network
• Actively contributes to team goals.
• Meet quality, quantity and timelines in all assigned projects.

Nov 2011 – July 2012: Scientist (GMP Operation). (Contract).
Achievement: Support and collaborates all team members and provide scientific input to improve Product quality.

• Provide technical input and partnership with formulation scientists for the manufacturing of drug product batches
• Supported technology transfer (scale-up) of New Products and Process Improvement from Development to clinical manufacturing.
• Complete Change Management records, keep current with all training GMP and Safety training
• Prepared and reviewed documents to support technical project including master
• batch records, protocols, deviation, and technical reports.
• Collaborates with team members to facilitate the deliveries of DS and/or DP.
• Actively participate in project team /meeting /network
• Actively contributes to team goals.
• Meet quality, quantity and timelines in all assigned projects.

Jan 2011 – Nov 2011: Scientist – Technical R&D (Contract)
Achievement: Actively involve pilot plant activity includes Development support for manufacturing of Rx product using different technology for Clinical studies.
Includes oncology.

• Perform scientific experiments/plant activities for oral solid dosage forms using manufacturing process such as: Dry granulation, wet granulation, roller compaction, hot melt extrusion, encapsulation and compression and coating under minimal guidance.
• Seeks for proactively support and coaching from project leader, scientific
Expert or other team members during the whole process.
• Identify and evaluate the critical formulation factors (e.g., components and process)
• Manufacture lab scale to pilot scale including clinical batches for study purposes.
• Provide raw data documentation, evaluation and results interpretation.
• Collaborates with team members to facilitate the deliveries of DS and/or DP.
• Actively participate in project team /meeting /network
• Actively contributes to team goals.
Meet quality, quantity and timelines in all assigned projects.

2007 – 2010: Scientist Technical R&D
Achievement: Support Aspirin chain formulation for OTC drugs

• Perform and document scientific experiments/plant activities for oral solid dosage forms using manufacturing process such as: Dry granulation, wet granulation, roller compaction, hot melt extrusion, encapsulation and compression and coating under minimal guidance.
• Identify and evaluate the critical formulation factors (e.g., components and process)
• Manufacture and package lab scale (stability) to pilot scale batches for study purposes.
• Support the evaluation, selection and implementation of process equipment that is robust, reliable and aligned with manufacturing strategy
• Analyze data; provide technical interpretation in technical reports.
• Collaborates with team members (analytical chemists, and manufacturing technicians) to facilitate the deliveries of drug products/active pharmaceutical ingredients and to solve analytical or formulation problems.
Report scientific/technical results internally.

2005 – 2007: Scientist – Technical R&D Consumer Healthcare
Achievement: Actively involve pilot plant activity includes Development support for manufacturing of consumer product using different technology for Clinical studies.

• Supported (scale-up) of Existing / New Products and Process Improvement from Development to manufacturing using manufacturing equipment such as: Dry granulation, wet Granulation, roller compaction, encapsulation and compression and coating.
• Support the evaluation, selection and implementation of process equipment that is robust, reliable and aligned with manufacturing strategy
• Participate in qualifying alternate supplier of API and excipients.
• Prepared and reviewed documents to support technical project including master batch records, protocols, stability summaries, and technical reports.
• Support QA and Manufacturing in Complaints & Investigations and CAPAA.

2003 – 2005: Process Engineer – Technical R&D
Achievement: Support technology transfer and product launch from development.

• Supported technology transfer (scale-up) of Existing / New Products and Process Improvement from Development to manufacturing using manufacturing equipment such as: Dry granulation, wet Granulation, roller compaction, encapsulation and compression and coating.
• Execute process validation activities for product transfers, new active ingredient variants, new excipient sources, new equipment
• Support the evaluation, selection and implementation of process equipment that is robust, reliable and aligned with manufacturing strategy
• Participate in qualifying alternate supplier of API and excipients.
• Prepared and reviewed documents to support technical project including master batch records, protocols, stability summaries, and technical reports.
• Support QA and Manufacturing in Complaints & Investigations and CAPAA
• Present and contribute scientific results to publications and presentations.

1998 – 2003: Process Engineer – Technical Services
Achievement: Support technology transfer and product launch from development.

• Supported technology transfer (scale-up) of Existing / New Products and Process Improvement from Development to manufacturing using manufacturing equipment such as: Dry granulation, wet Granulation, roller compaction, encapsulation and compression and coating.
• Optimize new product development and scale-up manufacturing process if required
• Execute process validation activities for product transfers, new active ingredient variants, new excipient sources, new equipment
• Support the day to day activities on the production floor.
• Collaborates with team members (formulators, analytical chemists, and manufacturing technicians) to facilitate the deliveries of drug products/active pharmaceutical ingredients and to solve analytical or production problems.
• Prepared and reviewed technical documents to support technical project.
• Report and present scientific results internally and contribute to presentations.

FOR FULL RESUME call 505-207-7740 or email jobs@pharmaboard.com