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Project Manager Manufacturing

Location:
Fremont, CA
Salary:
$45-$50 per hour
Posted:
April 26, 2014

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Resume:

Kevin R. Trimble

*** ********* *** ( Palo Alto, California 94306

H 650-***-**** ( C 650-***-**** ( acdvmc@r.postjobfree.com

Summary

A highly knowledgeable, results-driven regulatory professional with

broadly diverse expertise encompassing regulatory submissions and

compliance, auditing, business process reengineering, corrective and

preventive actions, object-oriented scanning, project management,

quality compliance, R&D/GMP manufacturing. Demonstrates exceptional

interpersonal and communications skills to contribute both

independently and as part of a team. A reliable producer who excels

in challenging environments where adaptability and a strong

understanding of the business acumen contribute to the growth of a

company.

Experience

Bayer HealthCare LLC ( formerly Conceptus) Milpitas, California

Regulatory Affairs Associate Contractor October 2013 - Present

Managed administrative support to the Regulatory and Clinical Affairs

Department including library organization, electronic and hardcopy

correspondence filing, regulatory research, clinical trial agreement binder

assembly. Managed the migration of the Conceptus regulatory submission

database into the Bayer Healthcare LLC regulatory data infrastructure while

learning new submission systems. Interfaced with the BHC Legal Department,

CA Secretary of State, and USLegalization.com for Apostille of

Declarations, Power of Attorneys and Authorizations for BHC OUS

distributors and affiliates. Read and understood the CDRH Unique Device

Identifier (UDI) Guidance for Industry leading the assignment of a UDI for

the Essure device. Conducted literature searches supporting Investigative

Device Exemption (IDE) and Annual Report submissions.

Pharmacyclics Sunnyvale, California

Regulatory Affairs Associate Contractor July 2013 - August 2013

Extracted Mfr. Report No., Study Protocol No., Events, Date Received, and

Analysis of Similar Results from Drug Safety's MedWatch Forms for both 7-

day and 15-day Safety Report submissions. Wrote the submission cover letter

and completed Form FDA 1571 for the IND. Prior to Pharmacyclics' final

approval to the Regulatory Operations CRO for submission via the ESG to the

FDA, worked with Regulatory Operations staff to upload the submission to

the FTP-server and reviewed Safety Report submissions from CRO using the

eCTD Viewer. Maintained filing systems for IND and NDA correspondence

(email, letter, and facsimile) - electronically and hardcopy binders. Kept

training requirements compliant.

MAP Pharmaceuticals Mountain View, California

Senior Research Associate/Contractor, Research May 2010 - March 2013

Reviewed numerous CTD Quality Modules sections of the Levadex submission

working with section authors and regulatory project manager to facilitate

expeditious reviews. Participated in Levadex PAI backroom preparedness

activities. Managed the pharmaceutical development equipment qualification

project - qualifying 18 pieces of equipment with 48 change-controlled

documents in 90 days while coordinating third-party equipment vendors to

schedule the work including generation, approval, and execution of

protocols. Managed the executed protocol review process with third-party

vendors and MAP QA. Managed the development, led the execution, and

authored technical reports supporting CTD section content for aerosol

characterization studies evaluating aerodynamic particle size distribution

(APSD) and dose content uniformity (DCU) of Levadex and MAP pipeline

products.

MICRUS ENDOVASCULAR San Jose, California

Consultant, Regulatory January 2010 - May 2010

Assembled Technical File design dossiers in compliance with 21 CFR 820

(QSR), ISO 13485 (QMS), Notified Body CE authorization, and Declaration of

Conformity for device portfolio including manufacturing specifications and

marketing literature for company's international distributors. Obtained

required authentications - Embassy U.S. Apostille, U.S. Department of

State, or State of California authentications per requirements of

distributor's country. Collaborated with legal, assuring proper disclosure

of information.

Anesiva South San Francisco, California

Scientist, Formulation Development September 2007 - September 2008

Led and executed process development studies of excipient compatibility for

parenteral product development. Implemented execution and HPLC analysis of

development stability studies of lead parenteral product and authored

technical summary report. Managed CRO selection and interface, providing

timely results and driving informed product development decisions.

Nektar Therapeutics San Carlos, California

Senior Research Associate, Formulation Engineering January 2005 - May 2007

Developed and led DOE development physicochemical stability studies leading

to formulation identification for further development. Collaborated with

manufacturing and quality systems to complete studies on time and authored

technical report trending stability data.

Senior Research Associate, Chemical Analysis March 2001 - December 2004

Led DPI excursion studies cross-functional project team - designed

development protocols, executed HPLC analyses, powder APSD, and particle

surface morphology - for excursion studies. Established formulation and

device environmental performance metrics.

Research Associate III, Clinical DPI Feasibility June 2000 - March 2001

Collaborated with validation engineers to commission potent molecule lab

isolators prior to leading clinical manufacturing campaign. Authored change-

controlled batch production records, manufacturing SOPs, and final product

release specifications. Reviewed executed BPR for manufacturing department

prior to QA batch release.

QA Specialist I, QA Operations

March 1998 - June 2000

Inspected clinical manufacturing facilities prior to and upon completion of

clinical batch production for adherence to cGMP regulations and internal

quality procedures. Led GMP material receipt inspection, sampling, review,

and release to appropriate segregated warehouse locations.

Research Associate II, Pharmaceutical Development April 1997 - March 1998

Designed and executed DOE-based API jet-milling study while managing

international and domestic CMOs processing neat dry powder formulation.

Led and executed KF moisture and thermal DSC analyses on the milled

powders.

Additional CMC Experience

Oread, Palo Alto, California, Scientist, 1996-1997 - [Authored GMP

manufacturing technical reports]

Roche Bioscience, Palo Alto, California, Scientist, 1994-1996 - [Pilot

plant GMP manufacturing and technology transfer]

Syntex, Palo Alto, California, Chemist II, Chemist III, 1990-1993 -

[Parenteral drug delivery and drug delivery research]

Life Technologies, San Jose, California, QA Supervisor, 1988-1989 -

[Managed HPLC column testing/packaging operations]

Syntex, Palo Alto, California, Chemist II, 1984-1988 - [Stability chemist]

Letterman Army Institute of Research, San Francisco, California, Biological

Sciences Assistant, 1981-1984 [Blood research]

Education

University of Tennessee, Knoxville, Tennessee

B.A., Biology, 1978

Certification

University of California Santa Cruz Extension Silicon Valley, Santa Clara,

California

Certificate of Regulatory Affairs, 2009



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