MARK A. SCHREIBER, Ph.D.

650-739-9530

markschreiber01@gmail.com

Looking for new opportunities as:

Senior Director Analytical Chemistry

Accomplished in Analytical R&D, Quality Control, Pharmaceutical Development, Clinical Supplies, and Stability programs. Successfully led Analytical Development, CMC Development and QC teams.

Provided high quality CMC sections for IND's, NDA's, PMA's and supplements.

Strong technical abilities, leadership, flexibility, and a “get-it-done” attitude.

• Thorough understanding of the drug development process, including all analytical support needed for initial drug substance through formulation development, including IND & NDA filing
• Comprehensive knowledge of CMC regulatory and guidance documents
• Goal-oriented with strong leadership capabilities.
• Proven ability to work in unison with staff, management, and cross-functional teams – locally, nationally, and internationally.
• Strong written and oral communication, and presentation skills
• Highly flexible and versatile, managing change effectively
• Directed staff of up to 35 chemists, including Ph.D.’s, managers, and junior staff
• Successful interactions with FDA and notified body investigators and reviewers, on-site and at CDER
• Publications and presentations (list available)

EXPERIENCE

Alexza Pharmaceuticals, Mountain View, CA

Director, Quality Control (2013-2014)

• Lead Quality Control, Analytical Development, and Microbiology/Environmental Monitoring
• 3 manager direct reports + 13 indirect reports, and growing
• Transitioned the Quality Control Department from R&D to Commercial mindset
• Improved turn-around time of testing
• Provided backup strategies for all analytical equipment to ensure maximum “up time”
• Close interactions with FDA during inspections
• Increased overall compliance to be FDA inspection ready
• Recruiting of additional staff to ensure timely turn-around times, even during peak periods
• Work closely with a cross-functional management team, including other Directors, Sr. Directors, and VP's, trouble-shooting issues, change management, and ensuring sustainable strategic corporate growth

Biotronik AG, Buelach, Switzerland

Head, Analytical and Microbiology Labs (2009-2013)

• Construction and start-up of new analytical labs (development and QC)
• Evaluation of analytical and formulation processes previously established at Biotronik
• Worked closely with process development team to improve manufacturing process
• Recruitment of entire analytical staff at the Buelach site for QC and development
• Identification and repair of short-falls in Analytical methods and validations
• Development and validation of analytical methods used in development projects
• Rapid scale-up of analytical testing to successfully launch Biotronik's first Drug-Eluting Stent
• Established Stability Review Board to put policies in place, evaluate existing stability studies and plan future registration studies
• In-process control and release testing of commercial products
• Microbiology testing and validation of sterilization for numerous products, including cleanroom monitoring
• Manage budget of 1.5 million Swiss Francs

Conor Medsystems, a Johnson & Johnson Company, Menlo Park, CA

Director, Analytical Development (2006-2008)

Provided strategic and tactical direction with regard to analytical chemistry and drug formulation to ensure compliance with US and international regulatory requirements being successful in securing regulatory approvals on a timely basis, while managing 3 functional units.

• Achieved first-in-human testing of a new drug-eluting stent (DES) in 11 months
• Completed the CMC section of a PMA submission for CoStar within 11 months of joining Conor by personally writing, as well as managing authorship by consultants
• Developed and validated all analytical methods for Corio and SymBio ex-US clinical trials within 2 months of joining Conor, meeting a key milestone for the company
• Managed capital and expense budgets ensuring resources were available meeting departmental and corporate goals
• Recruited and hired more than 15 chemists and 2 managers to support the 3 functional units
• On-going management of staff up to 35 with organizational changes/reductions
• Led analytical methods development, validation and transfer
• Led in-process testing, clinical lot release, and commercial lot release
• Providing analytical expertise to Development projects teams
• Developed systems and procedures for sample tracking, method development/validation/transfer, stability and OOS/OOT Investigations, improving efficiency and compliance
• Championed and led the team that developed, validated, and implemented a Laboratory Information Management System (LIMS)
• Audited and managed contract labs for raw material testing
• Communicated frequently with senior management and multi-disciplinary teams

Berlex Laboratories, Wayne, NJ

Section Head/Manager (2000-2006)

• Led Analytical and CMC teams to provide laboratory activities/data/reports to support IND/NDA filings and supplements
• Led and participated with management team to continuously improve systems including: infra-structure, budget control, compliance, training, sample flow and testing improving compliance and efficiency
• Led method validations and transfers meeting project objectives and regulatory requirements
• Audited and recommended selection of firms for potential acquisitions
• Developed strategies and managed stability program for development projects and marketed products
• Led project team to develop an ANDA product and filing the ANDA to provide a revenue stream of $5-10 million for the dermatology business unit

DuPont Pharmaceuticals, Wilmington, DE

Principal Research Scientist/Group Leader (1991-2000)

• Led methods development/validation/transfer
• Provided critical analytical support for drug substance and formulation/process development, including process validation, clinical release and stability testing
• Provided analytical expertise to Project teams and CMC sub-teams
• Wrote analytical portion of CMC sections for regulatory filings with minimal regulatory comments
• Led the improvement of lab operations processes, including: release testing, specification setting, stability, OOS/OOT procedures, sample flow, computerized systems
• Hands-on management of team providing departmental support for FTIR, HPTLC, and Preparatory HPLC

PREVIOUS EXPERIENCE

DuPont Pharmaceuticals, Wilmington, DE

Research Chemist/Senior Research Chemist/Group Leader

• Developed and validated Analytical methods (HPLC and GPC/SEC)
• Technical support for marketed products requiring extensive interactions with contract manufacturers nationally and internationally
• Automated sample preparation using robotics (Zymark)
• Developed and Validated Software for chromatographic data analysis
• Management of chromatographic data system

EDUCATION

Ph.D., Analytical Chemistry, University of Virginia

B.A. , Chemistry (ACS Certified), Franklin and Marshall College

Dale Carnegie Course Graduate

PROFESSIONAL AFFILIATIONS

American Chemical Society

American Association of Pharmaceutical Scientists (including APQ Section and Stability Focus Group)

Pharmaceutical Stability Discussion Group

Publications List

Available upon request