Quality Assurance Manufacturing

Peter Curtiss

*** ** ************ **. *** T***

Corvallis, OR 97333

Cell: 541-***-****

Email: *******@***.***

OBJECTIVE

To obtain a position in the Biotech or Pharmaceutical industry that

will benefit from my management skills, leadership roles, as well as,

substantial GMP manufacturing, process development, and synthetic organic

synthesis experience.

SKILLS

. Experienced in multi-step synthetic organic reactions (research,

synthesis, purification, and analysis) including both solution and

solid phase synthesis and purification of peptides, oligomers, and

intermediates.

. Possess excellent analytical and problem-solving skills.

. Proven ability to work under pressure and consistently deliver results

within aggressive timelines.

. Excellent communication skills with the ability to work both

independently or in a cooperative team environment.

. Proficiency in Microsoft Office applications.

EMPLOYMENT HISTORY

July 2007-Sep 2009, Manufacturing Manager, AVI BioPharma, Inc., Corvallis,

Oregon

. API production management in both cGMP and development settings

including project planning, scheduling, labor allocation, materials

coordination, and coordination of goal objectives with manufacturing

support departments (Quality Control, Quality Assurance, Research and

Development, Facilities). Hands-on assistance in all stages of the

synthesis and purification processes within the GMP facility including

solid-phase synthesis, solution phase conjugations, tangential flow

filtration, ion-exchange chromatography, lyophilization and packaging

of materials (conducted in a BSL II safety cabinet).

. Gained increased knowledge and familiarity of FDA CFR and ICH

guidelines through daily interaction with Quality Assurance.

. Experienced in writing and revisions of production batch records

(BPR), standard operating procedures (SOP), and other controlled

documents.

. In 2008 and 2009, led the manufacturing team to an API production

increase of four times that of 2007.

. Achieved company goals and timelines for API used in the filing of two

Investigational New Drug (IND) candidates in 2008 and an additional

IND to be filed in late 2009. Achieved all timelines for API material

for use in pre- and early-phase clinical trials of Duchenne's Muscular

Dystrophy (DMD).

. Investigated, assessed, and implemented solutions to oligomer

processing to meet deadline expectations and maintain retention of

quality controls.

. Assured high quality API purification through critical assessment of

HPLC and MS data.

. Managed the implementation of new labor and equipment in the GMP

department; assisted in the interviewing of cross-departmental

candidates.

. Assisted R&D with studies to investigate production changes for

oligomer chemistry or purification. Planned and conducted departmental

studies for process improvement; enforced required study deadlines

when assigned to Manufacturing Associates.

. Applied effective employee training to greatly improve manufacturing

documentation practice and documenting quality over that prior to

2007. Met Quality Assurance standards for addressing and closing

process deviations and associated corrective or preventive actions.

. Led department management in the evaluation and hiring of eight

Manufacturing Associates and Assistants. Developed a Quality Assurance

approved training SOP for current and new employees. Trained staff in

both GMP documentation and Manufacturing processing. Ensured that all

training and work performed was documented in accordance with Quality

Assurance.

. Reviewed batch production records, logbooks, material specifications,

work or preventive maintenance orders prior to submission to Quality

Assurance. Assessed the quality of BPR and SOP documents and initiate

revisions or new documents as needed. Participated in formal document

reviews of all new or revised controlled documents.

. Determined cost effectiveness of manufacturing raw materials and

related equipment; devised alternatives when needed, and presented

findings to senior management.

. Member of the AVI Safety Committee; identified and addressed

manufacturing or facility issues to ensure a safe working environment.

May 2006-Mar 2007, Chemist, cGMP Manufacturing, American Peptide Company,

Inc.,

Vista, CA

. Performed small to large scale synthesis of peptides and segment

coupling, in solution- or solid-phase under cGMP or cGLP conditions.

. Purified peptides chromatographically and analyzed by HPLC; structural

and purity analysis obtained from HNMR and LC/MS spectral data.

. Performed process development and purification of peptides and

intermediates in solution-phase under both cGMP and development

conditions.

. Ensured all work was performed and documented according to SOPs and

safety standards.

Jan 2006-Mar 2006, Research Associate, High-Throughput Medicinal Chemistry

Group, Chembridge Research Laboratories (CRL), LLC., San Diego, CA

. Researched and synthesized small molecule intermediates using parallel

synthesis for Hit-to-Lead targeting in compound libraries ranging from

65 to 1700 molecules.

. Synthesized and purified intermediates for internal Medicinal

Chemistry group.

. Prepared completed library plates for high-throughput purification.

Feb. 2003-Jan. 2006, Research Associate, Chemistry Research Group, CRL

. Researched synthetic proposals; determined optimal scale-up

conditions.

. Performed synthetic organic reactions of small-molecule compounds

scaled for mg to kg.

. Purified targets using flash chromatography, extraction, re-

crystallization, and distillation techniques.

. Utilized analytical instruments and techniques (NMR, LC/MS, mp, TLC,

FTIR) to characterize, identify, and determine purity of products;

ability to maintain high purity on all final compounds.

. Ensured that all laboratory work was performed in full compliance of

GLP and established safety standards.

. Packaged and shipped final products along with concisely written

experimental reports.

. Presented research findings and project status in weekly group

meetings and submit weekly reports utilizing ISIS Draw and MS

PowerPoint.

EDUCATION

Bachelor of Science, Chemistry (Biochemistry Emphasis), GPA: 3.2/4.0, Dec

2002

California State University, San Marcos

San Marcos, CA

Effective Management Practices Seminar, Oregon Bureau of Labor and

Industries, 2007

References available upon request

Contact this candidate