MARC A. HAWKINS

* ***** ****,

South Orange NJ **079

973-***-**** (H)

908-***-**** (O)

pekxap@r.postjobfree.com

SUMMARY OF KNOWLEDGE AND SKILLS

A goal oriented and experienced pharmaceutical professional, with strong analytical development and project management skills seeks a challenging position with an organization where my experience and skills can be fully utilized to enhance my personnel and professional growth.

PROFESSIONAL EXPERIENCE:

Supervisor

Analytical Development, Actavis (formerly Alpharma), Elizabeth NJ 03/04-Present

• Manage a team of seven (7) scientists and chemists in analytical research and development.

• Participate as analytical R&D representative on cross-functional project teams with representatives from other departments (API sourcing, Formulation development, Regulatory, Process Development and Project Management) to accomplish business objectives (ANDA or NCE filing of pharmaceutical finished product in solid dosage forms).

• Design, supervise, implement and ensure that analytical methods (assay, related compound, dissolution, identification, particle size, residual solvent and cleaning validation) are developed, validated and transferred for a wide variety of APIs and drug products.

• Organize and deliver effective, on-time analytical support to early formulation development and alternate source API candidates. Organize API and finished product release testing, process validation, stability data generation, evaluation and interpreting.

• Provide guidance to the team members in scientific and cGMP matters to accomplish tasks that are scientifically sound and cost/time effective. Analyze and evaluate analytical data. Review and determine the acceptance of analytical work in terms of accuracy, consistency and integrity in compliance with FDA and ICH guideline as well as company SOPs.

• Carry out critical experiments and studies in support of regulatory submissions. Provide analytical methods, experimental data and reports to answer FDA deficiency letters.

• Interact with the FDA during inspections as an analytical SME for new and Marketed Products.

• Conduct laboratory investigations. Write, review and approve investigation report for regulatory submissions.

Supervisor of Marketed Product Support

Quality Control, Alpharma, Elizabeth NJ 02/03-03/04

• Manage a team of chemists in Quality Control, dedicated to solving analytical challenges for Marketed Product methods.

• Provide technical leadership and guidance in scientific matters for Quality Control.

• Design technical experiments and write technical reports to support method changes for Marketed Products.

• Perform experiments and troubleshoot analytical problems for various issues encountered during a method life cycle.

• Participate in the cross-functional Remediation Team, which is responsible for the prompt regulatory filing of new methods and specifications for Marketed Products

• Interact with the FDA during inspections as an analytical SME for Marketed Products.

• Write and review report, protocol and analytical methods for a variety of scientific and regulatory purposes.

Product Champion

Analytical R&D, Siegfried-USA, Pennsville NJ 03/01-02/03

• Developed and validated analytical methods for assay, impurities and cleaning validations of intermediate and finished drug substances.

• Prepared method protocols and technical reports for validation of analytical methods and qualification of instrumentation.

• Conducted technical transfer of new analytical methods from R&D to QC.

• Carried out sample analysis using HPLC, GC, UV/VIS, IR and XRD on new drug substances.

• Performed IQ/OQ/PQ and initiated change control for lab equipments. Reviewed lab notebooks and instrumental logbooks.

• Coached and tutored chemist on instrument operation and software application (Millennium and TurboChorm).

R&D Chemist (Assoc., I, II & III)

Analytical R&D, ESI Lederle Pharmaceuticals, Cherry Hill NJ 11/94-03/01

• Develop, validate and troubleshoot analytical methods for assay, ID, Impurity and Chromatographic purity, related substances, excipients and residual solvents for drug substances, finished products and stability samples.

• Investigate various product related issues encountered at any stage of product development.

• Analyze, interpret and evaluate analytical data.

• Write protocols, reports and test methods.

• Design and execute experimental studies of analytical methods development for drug substances, impurities and excipients for finished products to support product development.

• Prepare, review and revise SOP, Instrument Training Manuals, Calibrations Procedures, and Specifications.

• Monitor and report progress of group projects to upper management and product teams.

• Received three promotions over a 6-year period within the Analytical R&D department.

EDUCATION:

• B.S. (General Science), Fordham University, Bronx NY – 1994

REFERENCES:

• Furnished Upon Request

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