Project Manager Manufacturing

Jan Woraratanadharm, Ph.D.

**** ********* **, #***, *******, NC 27617

*******@*****.***

804-***-**** (cell)

www.linkedin.com/pub/jan-woraratanadharm/8/77b/985

OBJECTIVE: Interest in a slight career change to work in GMP manufacturing (including process

and/or assay development, upstream/downstream processes), QC, QA, and GLP work.

Willingness to start at the ground floor if position advancement is available.

SUMMARY

Results-oriented professional with eight years of experience in the biotech industry. Relevant

experience in:

• Laboratory Skills: R&D work in mammalian cell culture, bacterial culture, and other

molecular biology/immunology laboratory techniques. Trained on use of fermenter and

AKTA Prime FPLC system.

• Knowledge of GMP/GLP: company Project Manager on GLP and GMP projects

outsourced to CROs/CMOs. Coursework in cGMP, GLP, CMC, and validation. SOP

development for tech transfer of methods to CMO.

• Soft skills: effective oral and written communication of laboratory results to internal and

external audiences; Excellent problem solving, time management, analytical, adaptability,

listening, and leadership skills; Ability to execute experiments independently and in a team

environment; Highly organized; Excellent attention to detail; Ability to work under pressure

and adhere to deadlines; Ability to quickly learn new technologies under minimal

supervision and apply to company needs.

EDUCATION

Ph.D. in Microbiology and Immunology, Medical University of South Carolina, Charleston, SC

Dissertation: “Novel Transcriptional Regulation Strategies for Targeting Gene Therapy

Vectors for the Treatment of Prostate Cancer” PI: John Y. Dong, M.D., Ph.D.

B.A. in Biology (Chemistry minor), University of Virginia, Charlottesville, VA

Project: “Expression Analysis of Interleukin-1 Type II “Decoy” Receptor During Chronic

Gut Inflammation” PI: Theresa Pizarro, Ph.D.

Additional professional training:

BioNetwork Capstone Center, Raleigh, NC

“Elements of Current Good Manufacturing Practices (GMP)” – 1.6 CEUs

“Good Laboratory Practices (GLP): FDA & EPA Regulations” – 0.8 CEUs

“Basic Concepts of Validation” – 0.8 CEUs

“Operations in Biotechnology Processes” - 3.6 CEUs

PDA Training and Research Institute, Washington, DC

“What Every Biotech Startup Needs to Know about CMC Compliance” – 0.6 CEUs

PROFESSIONAL EXPERIENCE

Jan Woraratanadharm, Ph.D.

*******@*****.*** / 804-***-**** (cell)

Global Vaccines, Inc., Research Triangle Park, NC (January 2010 to Present)

• Project Manager on GLP/GMP outsourced projects outlining product-specific Study

Design requirements to contract research organization (CRO) performing GLP/non-GLP

toxicology work for company. Drafted SOPs for tech transfer of methods to contract

manufacturing organization (CMO) performing GMP process development work on

company vaccine adjuvant product (2010-present)

• Grant Proposal Manager assisting PI’s with organizing proposal writing teams, setting

and managing timelines, writing scientific content, and developing administrative pieces

(cost proposals, subcontracts, biosketches, figures, references, editing) (2012-present)

• Regulatory Manager with primary responsibility of maintaining registrations/assurances

with Office of Laboratory Animal Welfare (OLAW), Office of Biotechnology Activities (OBA),

US Department of Agriculture (USDA), Drug Enforcement Administration (DEA),

Occupational Safety & Health Administration (OSHA), and training personnel on laboratory

safety and Financial Conflict of Interest (FCOI) regulation (2010-present)

• Staff Scientist supervising laboratory work conducted by lab specialist working to develop

manufacturing processes, SOPs for company’s lead product (2011-2012)

Humacyte, Inc., Research Triangle Park, NC (February 2014 to Present)

• Short-term Contract Consultant assisting in rewriting manufacturing SOPs in

preparation for technology transfer of methods to CMO. Received training in Good

Documentation Practices (GDP) and company gowning and aseptic technique SOPs for

cleanroom. (2014-present)

GenPhar, Inc., Mount Pleasant, SC (May 2005 to December 2009)

• Project Manager on GLP/GMP outsourced projects outlining product-specific Study

Design requirements to CRO performing GLP work on company vaccine product. Also,

communicating manufacturing requirements for GMP material being manufactured by

CMO (2005-2009)

• FDA Liaison having spearheaded company’s first two Pre-IND meetings with the FDA.

Responsibilities included composing and submitting Pre-IND Read-ahead documents and

direct communication with the FDA for company vaccine product. (2006-2009)

• Grant Proposal Manager assisting PI’s with outlining proposals in accordance to

guidelines, organizing proposal writing teams, grant writing, setting and managing

timelines, and developing administrative portions of the grant proposals (cost proposals,

subcontracts, biosketches, figures, references, editing) (2005-2009)

• Manager of Scientific & Medical Affairs with primary responsibility of maintaining

registrations/assurances with OLAW and OBA (2005-2009).

• Staff Scientist supervising ELISA work conducted by lab specialist evaluating company’s

chikungunya virus vaccine (2009)

American Journal Experts (Dec 2013 to Present)

• Contract Editor providing English editing services to international researchers, thus

eliminating language barriers to getting their manuscripts published.

OTHER PROFESSIONAL QUALIFICATIONS

2

Jan Woraratanadharm, Ph.D.

*******@*****.*** / 804-***-**** (cell)

Managed/trained students/staff in laboratory techniques, including: mammalian cell culture,

molecular cloning, adenovirus work, ELISA, Western blot.

Laboratory Experience:

• Immunological and bioanalytical testing (ELISA, Western blot)

• Tissue culture (mammalian cell culture, adenovirus transduction studies, BSL-2)

• Molecular cloning (plasmid, adenovirus)

• DNA/RNA analysis (bacterial culture, purification, RT-PCR, Southern blot, Northern blot)

• Cell purification from fresh human and mouse tissue (human epithelial cells, human

LPMC, human PBMC, mouse IEL, mouse IEC)

• Fluorescent microscopy

Computer Skills:

Microsoft Office, Microsoft Project, Adobe Photoshop, Adobe Illustrator, Adobe Acrobat,

Windows and Mac operating systems, Graphpad Prism, Vector NTI, FileMaker Pro

SELECTED PUBLICATIONS (out of 18)

1. Pratt WD, Wang D, Nichols DK, Luo M, Woraratanadharm J, Dye JM, Holman DH, Dong

JY. Protection of Nonhuman Primates Against Two Species of Ebola Virus Infection with a

Single Complex Adenovirus Vector. Clin Vaccine Immunol 2010. Feb 24.

2. Swenson DL, Wang D, Luo M, Warfield KL, Woraratanadharm J, Holman DH, Dong JY,

and Pratt WD. Vaccine to confer to nonhuman primates complete protection against

multistrain Ebola and Marburg virus infections. Clin Vaccine Immunol 2008. 15(3): 460-7

3. Holman DH, Wang D, Raja NU, Luo M, Moore KM, Woraratanadharm J, Mytle N, Dong

JY. Multi-antigen vaccines based on complex adenovirus vectors induce protective

immune responses against H5N1 avian influenza viruses. Vaccine 2008. 26(21): 2627-39

4. Raviprakash K, Wang D, Ewing D, Holman DH, Block K, Woraratanadharm J, Chen L,

Hayes C, Dong JY, Porter K. A Tetravalent Dengue Vaccine Based on a Complex

Adenovirus Vector Provides Significant Protection in Rhesus Monkeys Against All Four

Serotypes of Dengue Viruses. J Virol 2008. 82(14): 6927-34.

5. Woraratanadharm J, Rubinchik S, Yu H, and Dong JY. Novel system uses probasin-

based promoter, transcriptional silencers and amplification loop to induce high-level

prostate expression. BMC Biotechnol 2007. 7(1): 9

6. Woraratanadharm J, Rubinchik S, Yu H, Fan F, Morrow SM, and Dong JY. Highly specific

transgene expression mediated by a complex adenovirus vector incorporating a prostate-

specific amplification feedback loop. Gene Therapy 2004. 11(18): 1399-407

7. Pizarro TT, Michie MH, Bentz M, Woraratanadharm J, Smith MF, Jr, Foley E, Moskaluk

CA, Bickston SJ, and Cominelli F. IL-18, a novel immunoregulatory cytokine, is

upregulated in Crohn's disease: Expression and localization in intestinal mucosal cells.

The Journal of Immunology 1999. 162(11): 6829-35

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