Development Manager

TAMARA C. LORD

**** ***** ***** *****

Sanford, NC 27332

http://www.linkedin.com/pub/tamara-lord/19/641/229

Cell: 919-***-**** ********@*****.***

SUMMARY

Knowledgeable, quality-conscious, and adaptable Process Development Scientist with extensive hands-on experience in Vaccine Development at bench, pilot, and commercial scales. Multi-disciplined team player with outstanding communication skills that are enhanced by verbal, written, and organizational skills. Authentic, effective communicator who employs a values-driven, team-oriented leadership approach to deliver results. Exceptional leadership abilities with proven success in

• Pilot Scale Purification Development • Scale-up and Technology Transfer

• Clinical Trial Manufacturing • GMP / GLP Environments

• Polysaccharides • Column packing (10 cm – 100 cm)

• Recombinant Biopharmaceutical Proteins • Aseptic Processing

• Authoring Batch Records / SOP’s / Protocols

• Buffer Prep at Lab and Pilot Scale • Process Validation

• FBC / Drug Substance Filling Operations

TECHNICAL SKILLS

Recovery Homogenization, Centrifugation, Acid Precipitation

Purification Chromatography (Affinity, IEX, HIC, AKTA Equipment, UNICORN Software), Tangential Flow Filtration (UF / DF), Microfiltration, Carbon Filtration, Depth Filtration, Fractionation

Analytical SDS-PAGE, Western blot, protein assays

PROFESSIONAL EXPERIENCE

NC STATE UNIVERSITY Golden LEAF Biomanufacturing Training & Education Center (Raleigh, NC) 2011-2012

Laboratory Manager

Supported the training of NCSU students and industry professionals on various downstream technical skills and provided purification processing support for various development projects.

• Prepared and executed downstream laboratory activities at large and intermediate scale.

• Provided operational and planning support for development projects that were part of BTEC’s Bioprocess and Analytical Services program.

• Supported classes and various projects by performing downstream activities such as: centrifugation, homogenization, chromatography and ultrafiltration processes.

PFIZER (Legacy Wyeth), Sanford, NC 2003 – 2010

Research Scientist

Led a team of scientists to develop purification processes for the production of research, toxicology, and clinical trial materials for multivalent vaccine candidates. Provided technical support for lab, pilot, and full scale development projects including recovery, purification, and analytical support.

TAMARA C. LORD PAGE TWO

PFIZER (Continued)

• Supported development projects by executing small-scale laboratory experiments and performing analytical testing in order to develop clinical manufacturing processes.

• Successfully led CTM Purification Group by managing a team of Scientists in order to execute the production of Phase I/II/III antigens by consistently demonstrating quality work and integrity.

• Played a critical role in the development of multiple aspects of protein and polysaccharide purification, by readily accepting and implementing last minute process changes with ease, and optimizing team performance.

• Met all timelines and ensured no batches were lost throughout a Pnuemo multi-valent campaign through strong leadership abilities and useful multi-tasking skills.

• Successfully performed hands-on process support functions required for the manufacture of clinical grade vaccine antigens under cGMP conditions by working effectively in a team environment and exhibiting valuable interpersonal and time management skills.

• Gained management attention and promoted to lead scientist by effectively planning and following-up to ensure processes were carried out correctly.

• Kept GMP compliance deviations near 0% by maintaining processes, facilities, and documentation through daily inspection of equipment logbooks and batch records.

• Facilitated Full Scale Development Facility preparations and the production of antigens by contributing technical input and innovative ideas.

• Optimized large scale processing through tech transfers as a Purification SME.

• Applied technical writing skills to author, review and track the approval of new SOP’s, compounding records, batch records, and protocols.

• Kept detailed laboratory notebook of experiments and data collected from analytical assays.

• Assisted with obtaining CTM Purification related information to support FDA, MCA and other regulatory agency audits / inspections, as well as internal corporate and site audits.

• Applied problem solving techniques to reach common goals and meet aggressive timelines by collaborating effectively with team members and other groups within and outside of Vaccine Development.

WYETH, Sanford, NC 2000 – 2003

Manufacturing Associate

Supported the 7-valent Prevnar formulation, a multi-billion dollar vaccine, which resulted in a 98% probability of protection against serotypes that caused 80% of pneumococcal disease in infants. Additionally, provided support for the Meningicoccal Group C vaccine, Meningitec, used to prevent meningococcal disease.

• Performed the activation, conjugation, and purification of polysaccharides by using the following techniques: Ultrafiltration, lyophilization, column chromatography, depth filtration, elutions, ethanol processing, and aseptic filtration of final product.

• Supported GMP processing by preparing, operating, and maintaining GMP equipment.

EDUCATION

MSCR, Clinical Research, Campbell University, Morrisville, NC

BS, Biology and Chemistry, Campbell University, Buies Creek, NC

COMPUTER SKILLS

Microsoft Word, Microsoft Excel, PowerPoint, Unicorn Software, Delta V Automation, LIMS, SAP

Contact this candidate