Engineer Quality Assurance

MICHAEL KINGSTON

**, ************* ******, ************-******, India.

Mob: 91-948******* Email: ***************@*****.***

ENGINEER RESEARCH ASSOCIATE

Area of Focus: Pharmaceutical, Biotechnology and R&D Sector

Self-motivated, team-player and diligent professional possessing a Master’s Degree in Biopharmaceutical

Technology combined with superior analytical skills and technical expertise encompassing GMP and Six

Sigma concepts. Equipped with extensive biotechnology and research background complemented with in-

depth understanding of process analytical technology. Capable of building rapport with management and

colleagues from all levels underscored by the ability to simplify and communicate complex scenarios.

Adept at working in an environment requiring problem resolution, with proven effectiveness to multitask in

a competitive, high-impact, and fast-paced environment while juggling with multiple priorities

simultaneously with good judgment. Utilize strategic planning and decision-making skills in streamlining

business processes and defining improvement processes to ensure efficiency. Well versed in English, Hindi and Tamil languages.

PROFESSIONAL SUMMARY

With advanced training and hands on experience on recombinant protein and vaccine production,

purification and characterization from bacterial and yeast expression systems, enthusiastic and adaptive

process development engineer offers superior bioprocess development, scale up and optimization skills,

combined with commitment to conducting research on biotechnology and biopharmaceuticals.

AREAS OF EXPERTISE

GMP, GLP, and ISO Guidelines, BSL-2 and BSL-3 Trainings

Design of Experiments (DOE)

Process Optimization, Scale-up, and Validation Studies for Bio manufacturing of Phase I-III

Products, including Vaccines, Cell Therapeutics and Proteins

Microbial and yeast Fermentation

Batch and Fed-Batch Stirred Tank Bioreactor Operation and Troubleshooting.

Cell-based Assays for Critical Product Quality Attributes (Alamar Blue and Trypan Blue Staining

for Cell Viability, Hem cytometer and Cedex / Flex Cell Counters for Total Cell Count,

Immunofluorescence Assay (IFA))

Membrane Filtrations (Ultrafiltration / Diafiltration / Tangential Flow Filtration)

Protein Analysis and Characterization (HPLC – Agilent 1200 Series with Chem Station, SDS-

PAGE, Blue Staining and Silver Staining, Western Blot, ELISA, UV-vis Spectrophotometry,

Densitometry Analysis)

PROFESSIONAL EXPERIENCE

Research Associate

Biocon Limited, Bangalore (JUN 2011- APR 2013)

Performed in-process sampling for wet weight analysis, microbiological control (checking for

contamination by slide preparation and staining) and concentration of antigen produced during the

process.

Performed data entry into the WFERMAC software for record keeping and used data for the

compilation of the BPR with tables and graphs.

Developed and implemented Standard Operating Procedures (SOPs), protocols and maintained

records and logbooks of all equipments as per current Good Manufacturing Practices (GMPs).

Evaluated equipment status, solutions, materials and processes by reviewing the pertinent records

and Monitored processes to identify opportunities for continuous improvement.

Coordinated with Quality Control and Quality Assurance for deviations, change control, batch

production records and campaign change.

Familiarity with equipment, such as Bio safety cabinets, CO2 incubators, Microscopes, pH meters,

Autoclave.

EDUCATION

MASTER OF TECHNOLOGY IN BIOPHARMACEUTICAL TECHNOLOGY (GPA: 8.1/10.0)

Anna University, Chennai (2011)

BACHELOR OF TECHNOLOGY IN BIOTECHNOLOGY (GPA: 8.1/10.00)

Anna University, Chennai (2009)

12TH GRADE (90.66/100)

Tamil Nadu state Board, (2005)

10TH GRADE (95.44/100)

Tamil Nadu state Board, (2003)

TECHNICAL PROFICIENCIES

Proficient in Microsoft Office Suite

Basic programming knowledge in C and UNIX.

Excellent hands on experience in Auto dock, Chimera, Chemsketch, Rasmol.

AWARDS & HONORS

Gold medalist in 10 TH Grade Examination (100% in science and Mathematics)

Prize winner in National level paper presentation at Bharath University, Chennai.

Available for Travel and/or Relocation

Contact this candidate