Scientist Ii Resume Example

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Jessica Claire
, , 100 Montgomery St. 10th Floor
Home: (555) 432-1000 - Cell: - - -
Professional Summary

PROFILE SUMMARY A goal-driven and hard-working professional with over 5 years of experience in the Pharmaceutical Industry. An adept professional with proven knowledge in good manufacturing practices, process validations, cleaning validations, equipment qualification, process improvements, technology transfer, risk assessments, life cycle management of commercial products and regulatory compliance. Skilled especially at maintaining a superb relationship with clients, and all levels of staff with a high degree of courtesy and professionalism.

  • Project Management
  • Statistical Expertise
  • Cleaning / Process Validations
  • Risk Assessments
  • Product Life Cycle Management
Work History
10/2017 to Current
Scientist II Eurofins Scient. Pittsburgh, PA,
  • Responsible for performing/monitoring all activities related to pre-validations (exhibit batches), process validation, cleaning validation, process improvements, technology transfer, alternate source qualification, experimental studies (trials) for process optimization and scale-up.
  • Accountable for preparation/review of cGMP documents to ensure accuracy of data and content which includes: change control, master batch records, master packaging records, process validation protocols/reports, update cleaning validation matrix for site, scale-up/technology transfer protocols/reports and standard operating Procedure related to MSTG department.
  • Responsible for providing technical information on drug products to regulatory affairs for submission of CBE, PAS, and annual reportable filings to regulatory agency.
  • Accountable for evaluating impact of various changes/addition to the cleaning validation matrix which includes: new products, new manufacturing equipment`s, cleaning agents, hold time studies, worst-case analysis.
  • Leads investigations, CAPA & risk assessment related to manufacturing, packaging and cleaning validations.
  • Perform cross-functional coordination with R&D department, regulatory affairs, production, quality assurance, quality control, engineering and other relevant departments to accomplish the assigned functional task.
  • Provide support/training to production department during process troubleshooting/process enhancement /capacity constraints and planning the projects timeline to meet the company goals.
  • Hand-on experience and troubleshooting of various equipment related to fluid bed technology, granulation, blending, milling, tablet compression, encapsulation and hot melt extrusion.
  • Performing process evaluation and trend analysis using statistical tools.
  • Actively participating in new product launch meetings and completing tasks as assigned.
  • Provide training/coaching to junior scientists regarding all the aspects of cGMP manufacturing, project execution, cGMP documentation and new technologies in pharmaceutical industries.
  • Provide support during regulatory/customer audits and to maintain site in compliance state.
08/2016 to 10/2017
Scientist I Wuxi Apptec Cranbury, NJ,
  • Worked under limited supervision of management.
  • Independently determines and develops approach to thorough and practicable solutions consistent with organization objectives.
  • Led Product/Process technology transfer, scale-up, optimization, and improvement projects.
  • Authored technical reports, protocols, specifications, procedures, experimental and validation/commercial batch records.
  • Assisted and executed alternate source qualification projects for Active Pharmaceutical Ingredients (API’s).
  • Organized root cause identification of product/process related investigations.
  • Performed process/equipment troubleshooting activities for production.
  • Provided off-hours on-call support to production department.
  • Executed and monitored experimental batches on manufacturing floor.
  • Reviewed GMP documents (MBRs & SOPs) and generates change controls.
01/2015 to 08/2016
Scientist I Wuxi Apptec Plainsboro, NJ,
  • Responsible for technical services support in manufacturing and troubleshooting of solid and liquid dosage pharmaceutical products.
  • Accountable for all aspects of process validation and cleaning validation activities, which includes preparing protocols, monitoring execution and final reporting in compliance with CGMP, applicable sops and FDA requirements.
  • Spearheaded Investigations, evaluated process deviations, creating Investigation Reports and implementing the necessary Corrective and Preventative Actions (CAPA).
  • Working knowledge of operating and troubleshooting of Fluid Bed Processor, Fluid Bed Dryer, Fitzmill, Comill, Vibrasonic Sifters, High Shear Granulator/Mixers, Tablet Coater, Tablet press, Mixing Tanks and all other equipment`s required for manufacturing of solid and liquid drug products.
  • Prepared, maintained and evaluated cleaning validation matrix.
  • Experience in calculating maximum allowable Carryover (MAC) residue limits for active ingredients and detergents.
  • Developing and Validating cleaning SOPs for manufacturing and packaging equipment`s.
  • Prepared and reviewed master batch records, official forms, standard operating procedures and change controls.
Expected in 12/2023
University of Illinois Urbana - Illinois City, IL,
Expected in 2014
Masters: Pharmaceutical Manufacturing
Steven Institute of Technology - Hoboken, New Jersey
GPA: 3.86
Expected in 2010
Bachelor of Pharmacy:
Rajiv Gandhi University of Health & Sciences - , Karnataka
GPA: 3.87

American Society for Quality (ASQ) Certified Quality Process Analyst (2016)

Certified Six Sigma Green Belt (2017)

Project Management Institute (PMI) Certified Project Management Professional (PMP) (2020)

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Resume Overview

School Attended
  • University of Illinois Urbana
  • Steven Institute of Technology
  • Rajiv Gandhi University of Health & Sciences
Job Titles Held:
  • Scientist II
  • Scientist I
  • Scientist I
  • MBA
  • Masters
  • Bachelor of Pharmacy

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