Development Project

Gary Allmaier

Email: abpwei@r.postjobfree.com

Address: *** ******** ****.

City: Sea Girt

State: NJ

Zip: 08750

Country: USA

Phone: 908-***-****

Skill Level: Director

Salary Range: $100,000

Willing to Relocate

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

Gary J. Allmaier, Ph.D.

607 Brooklyn Blvd.

Sea Girt, NJ 08750

908-***-**** (Cell)

OBJECTIVE

To contribute to the growth of a pharmaceutical research organization responsible for the development of therapeutic drugs using my 32 plus years of experience in the pharmaceutical industry.

SUMMARY:

Accomplished Analytical RD leader with a proven ability to work in conjugation with staff, management, and cross-functional teams locally and internationally to meet Corporate goals Thorough understanding of the drug development process, including all analytical activities needed to support initial drug substance development, formulation development, stability, and clinical supply release needed to advance a candidate through regulatory submissions Directed the activities of staff members, including Directors, Associate Directors, Group Leaders, Managers, and well as junior staff Successful record leading Analytical Development and CMC Development teams (approval of Abilify(r)) Chair of a Specifications Committee responsible for proposing and approving both development and commercial specifications for API and drug products Successful interactions with FDA inspectors Comprehensive knowledge of ICH and FDA regulatory/guidance documents Strong technical abilities, goal-oriented leadership, and a change agent with a get-it-done attitude Strong written/oral communication and presentation skills

EXPERIENCE:

Celgene Corporation

86 Morris Ave, Summit, NJ 07901

Director, Analytical RD (November 2007 August 2012)

Expanded Analytical RDs capacity and expertise to enhance the support of Discovery, Process Chemistry, Toxicology, Formulations RD, Clinical, Stability, CMC, Regulatory Affairs, and Technical Operations activities through the successful recruitment of senior leaders and support staff Responsible for leading all aspects of Analytical RD, which include API physical characterization, methods development/validation, reference standard qualification, development stability testing, GLP and GMP API release testing, clinical supply release testing, methods transfer, commercial method remediation, and trouble-shooting activities Chair of a Specifications Committee responsible for proposing and approving both development and commercial specifications for API and drug products Provided analytical development strategic and tactical direction to secure regulatory approvals on a timely basis. Responsible for the timely review of analytical CMC sections for IND, NDA and other documents required for regulatory submissions. CMC Development Team leader for the development of a Phase II drug candidate Supported the achievement of first-in-human testing of an NCE in Responsible for ensuring that Analytical RD investigations and CAPA are closed in a timely manner Managed capital and expense budgets ensuring resources were available to meet departmental and Corporate goals Authored several SOPs/policies, including handling of potential genotoxic impurities in API/drug product, as well as expiration dating assignment for API/drug product Communicated frequently with senior management and multi-disciplinary teams

McNeil Consumer Heathcare (OTC Division)

7050 Camp Hill Road, Fort Washington, PA 19034

Associate Director, Analytical Services (September 2005 November 2007)

Responsible for working closely with Operations and several Quality Site Managers to help maintain an uninterrupted supply of commercial products Planned and managed all method transfer activities to support the integration of Pfizers Consumer Healthcare product line Directed all laboratory activities that support analytical method remediation initiatives, Laboratory Operations efficiency improvements, and activities required to support manufacturing process changes/formulation changes Act as a scientific liaison between RD-New Product Development Teams and the Quality sites during method transfer activities by providing appropriate feedback to RD during the development of method validation/transfer protocols and reports Interface with the Quality Sites for the purpose of implementing new technologies and reducing the number of laboratory events to leverage its potential benefits throughout the OTC Sector Other responsibilities include directing activities related to the Quality Metrics Program, GxP Compliance MAP, and USP Compendial Review Team

Alpharma/Purepac (US Human Pharmaceuticals)

200 Elmora Avenue, Elizabeth, NJ 07207

Associate Director, Methods Development (July 2004 September 2005)

Responsible for the development and validation of a variety of analytical methods according to ICH validation guidelines to support generic formulations. Methods include API analysis (i.e. chiral purity, chemical purity, impurity analysis, analysis of counterions), drug product analysis on immediate, modified, and extended release tablets and capsules (i.e. potency, content uniformity, impurity/degradant analysis, dissolution) and equipment cleaning verification assays. Work closely with API vendors to ensure that the API received for formulation development and manufacture of biostudy supplies is of the highest quality Provide analytical support throughout the lifetime of a product, starting with early stage formulation development through testing and release of the biobatch to support ANDA filing

United States Pharmacopeia

12601 Twinbrook Parkway, Rockville, MD 20852

Director, Research and Development Laboratory (January 2003 - July 2004)

Responsible for supporting USPs vision of promoting public health through the setting of quality standards. Hosted Ministers of Health from foreign nations at USP Headquarters in an effort to promote collaboration and harmonization. Responsible for investigating customer complaints involving USP/NF monographs and USP reference standards by utilizing numerous analytical techniques Participating on several committees and task forces to support USP short and long term goals Supported the Continued Suitability of Use program which verifies the integrity of USP reference standards over an extended period of time Supported the New Product Development program is an effort to extend the supply of limited reference standards by incorporating freeze drying techniques or by providing reference standards as ready to use solutions Acted as a collaborating laboratory for the analysis of Lot F reference standards (new items for the USP Reference Standard Catalogue). Worked with several outside vendors on the evaluation of novel dissolution technologies (i.e. dissolution through a membrane, flow cell dissolution studies) Responsible for developing and implementing laboratory budget, recruiting laboratory personnel to ensure full staffing and performance, developing staff and succession plans to meet the future needs of USP

Bristol-Myers Squibb Pharmaceutical Research Institute

One Squibb Drive, New Brunswick, NJ 08903

Manager, Pharmaceutical Development Strategic Operations (April 2001 - January 2003)

Responsible for coordinating all aspects of several project teams, which included an in-licensed compound being co-developed by Bristol-Myers Squibb. This effort resulted in the successful approval of Abilify(r). Serve as a liaison between senior management and project teams, generating ongoing project and portfolio updates and preparing formal presentations Work directly with functional area team leaders from Drug Safety Evaluation, Process RD, Pharmaceutics RD, Analytical RD, Clinical Supply Operations, Regulatory Affairs, and Technical Operations to obtain their continued input and feedback on the needs and issues associated with the project Provide guidance to the project team, recommending improvements, techniques and tools to ensure successful functioning of the team Assisted in the preparation of development cost estimates and management of the supplies budget for each project Implemented a Knowledge Desktop, a searchable web-based document archive system which provides information to project teams and senior management to help enable informed decision making Assisted with the review and editing of the CMC section of an NDA filing

Analytical Research and Development---Various Titles (May 1989 - April 2001)

Responsible for the development and validation of HPLC, ion chromatographic (IC), and LC-MS methodology according to ICH validation guidelines for API and drug products, which include immediate and modified release tablets and capsules, injectables, oral solutions, lyophilized products, and drug-in-bottle formulations Responsible for several technology transfers of API and drug product methods to contract labs and to Bristol-Myers Squibb Technical Operations sites throughout the world Responsible for keeping several laboratories GMP compliant, including reviewing lab notebooks, maintaining lab chemists training records, and ensuring that instrument calibration was performed properly and in a timely manner Proficient with using Waters Millenium data acquisition system, SQL*LIMS, and Documentum. Named Analytical RD Project Team Leader for four (4) projects, which included an in-licensed compound being co-developed by Bristol-Myers Squibb. Worked in a team-oriented atmosphere with members of Drug Safety Evaluation, Process RD, Pharmaceutics RD, Analytical RD, Clinical Supply Operations, Regulatory Affairs, and Technical Operations to facilitate the IND/NDA development process.

Altana Inc.

60 Baylis Road, Melville, NY 11706

Development Scientist (May 1981 - April 1989)

Responsible for the development of analytical methodology for the analysis of pharmaceutical compounds in creams, ointments and lotions using HPLC, GC, IR, UV, and wet chemistry techniques.

Guardian Chemical Corporation

Hauppauge, NY 11717

QC Chemist (January 1980 - April 1981)

Responsible for the routine testing of raw materials used in pharmaceutical and industrial products.

EDUCATION:

Rutgers University

Piscataway, NJ 08855

Graduate Program in Pharmaceutical Sciences (May 1996 - May 1998)

Ph.D. Dissertation Title: Use of Electrochemically-Induced Oxidation as a Predictor for Chemical Oxidation of Peptides and Proteins

Thesis Advisor: Dr. Leonard C. Bailey

Ph.D. awarded in May 1998

Graduate Program in Pharmaceutical Sciences (September 1991 - May 1996)

Masters Thesis Title: Electrochemical Reduction of 2-,4-Dichloropyrimidine by Controlled Potential Electrolysis

Thesis Advisor: Dr. Leonard C. Bailey

M.S. awarded in May 1996

SUNY at Stony Brook

Stony Brook, NY

Undergraduate Program in Biochemistry (September 1975 - May 1979)

B.S. awarded in May 1979

PROFESSIONAL SOCIETIES

Sigma Xi - Full Member, 1998

Rho Chi - Full Member, 1998

American Association of Pharmaceutical Scientists (including Non-Clinical Focus Group)

PROFESSIONAL CREDENTIALS

USP Expert Committee Member, Cardiovascular Monograph Development, 2005-2010.

REFERENCES:

Furnished upon request.

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