STEPHEN A. WHEELER

***** ******* **** **** 442-***-****

Escondido, California 92026 adwvme@r.postjobfree.com

SUMMARY

Senior Manufacturing and Project Manager with 25-years experience, 24 within the bio-pharmaceutical industry, one year within the commercial cannabis industry. Community activist re: medical cannabis expanded patient access/business development. Demonstrated ability to:

build effective cross-functional teams and operations groups

establish project timelines and maintain team member accountability

organize and manage Chemistry, Manufacturing & Controls (CMC) activities from lead-candidate selection through product launch and commercialization

plan, author, execute and review process and facility equipment validation strategies and documents in support of both existing and new manufacturing facilities

effectively represent both Manufacturing & Supply Chain departments on technical transfer teams

identify drug substance and drug product demand (including packaging and labeling) and develop effective manufacturing strategies in support

develop risk assessments and contingency plans

influence decisions without direct authority

communicate effectively in all organizational directions, including Board of Director presentation

improve organizations

impact city legislator voting record

deliver with passion the therapeutics our patients require

ACCOMPLISHMENTS

Managed the site-transfer of cannabis Cultivation, Extraction, Fill/Finish and Packaging processes within the State of New York.

Led the facility startup and commercial launch of three New York State Department of Health-approved cannabis products (sublingual tinctures, gelatin capsules, vape pens).

Introduced engineering and quality disciplines into the cannabis industry from previous pharmaceutical experience.

Led the manufacturing design and startup of Mustang, Nevada facility.

Effectively established the CMC Team Project Manager function across four clinical programs resulting in:

zero CMC-impact to pre-clinical and clinical study start-date milestones

zero interruption in clinical drug product supply.

Led the development of Operations Department Key Performance Indicators for senior management review.

Led the manufacturing team writing a supplemental-BLA CMC-section associated with commercial product manufacturing site-change. Provided Regulatory Affairs with “first-in” submission input.

Led the establishment and continuing support of effective manufacturing compliance, environmental-control and safety sub-teams resulting in:

40% reduction in annual internal audit observations

zero agency-inspection manufacturing audit observations

32% reduction in manufacturing-area routine environmental monitoring (EM) alert/action level reports

3-consecutive years on-time manufacturing-area EM re-qualification

approximate 1/3 reduction in manufacturing-area reportable incidents/accidents.

Led the manufacturing team through two FDA Pre-Approval Inspections (PAI) and 1-product launch.

PROFESSIONAL EXPERIENCE

Americare Adult Day Health Care Facility

Driver Jun 2020 – Dec 2022

Deliver meals to homebound clients during pandemic facility closures.

Work split-shift client AM pickup and PM home-return subsequent to facility re-opening.

QOL Medical, LLC

Contract Operations Manager Mar 2018 – Jan 2020

Provide on-site support and project management consulting services regarding commercial Drug Product manufacturing activity oversight at client CMO.

MedMen · Culver City, California 90232 Feb 2017 – Feb-2018

Director, Manufacturing

Develop and execute company first-in-class vision regarding multi-state facility startups, product commercialization and vertical integration within the scope of:

super-critical CO2 and butane extractions,

raw extract winterization and ethanol refinement,

refined extract (Short Path) vacuum distillation,

chromatographic purification,

final formulation,

fill/finish activities through final packaging and labeling.

Xcelience (a division of Capsugel) · Tampa, Florida 33634 Jan 2016 – Nov-2016

Senior Manager, GMP Manufacturing Services

Direct oral solid dose manufacturing operations in a CDMO environment.

Manage the following staff:

3-shift Manufacturing Operations,

Manufacturing Technical Support (batch record review, SOP author, deviation, investigation and CAPA lead, metrics maintenance),

Manufacturing Planning/Scheduling,

Process Engineering,

Equipment and Instrument Specialists

Stephen A. Wheeler Consulting Services · Escondido, CA 92027 Dec 2005 – Jan 2016

Biopharmaceutical Chemistry, Manufacturing & Controls consultant

Provide client services including:

Contract Manufacturing Organization selection and manufacturing oversight,

project management from cell line development through Phase 1 clinical supply,

validation activity support,

business practice process mapping and continuous improvement

Certified Facilities, Inc. · Seattle, Washington 98104/San Diego, California 92122 May - Oct-2006

Provide facility and process equipment validation project management and execution services from System Requirements development through Design, Installation, Operational and Performance Qualifications. Co-chair Validation Implementation Team. Manage client Pre-approval Inspection projects. Provide client Facility/Maintenance Department management services. Participate in new business development activities.

Biogen Idec Pharmaceuticals · (formerly IDEC Pharmaceuticals Inc.) San Diego, CA Oct 00 - Nov 05

CMC Team Project Manager/Senior Analyst III, Supply Chain - Jan 03 -Nov 05

Manage all CMC Team activities in support of biopharmaceutical product development.

Standing member:

Program (Core) Teams

Comparability Teams

Technical Transfer Teams

Manufacturing Planning Team (internal &CMO)

Lot Disposition Team

Expiry Team

Ad hoc member:

Clinical Development Teams

Business/Finance Team

Commercial Development Team

Study Management Teams

Pre-clinical Development Teams

Additional Responsibilities:

Develop detailed supply chain models in support of active and planned internal and investigator-sponsored clinical studies.

Prioritize drug substance, drug product and finished goods manufacturing activities.

Provide oversight re: drug substance, drug product and cell bank Shipping cold chains.

Provide shipping qualification (PQ) deviation investigation/justification, summary report, final review and department approval.

Manage product destruction process.

Standing member Production Logistics/Materials Management Process Improvement Team.

Supply Chain lead point of contact re: all clinical drug product shipments.

Senior Manager, Manufacturing Operations - Oct 00 – Jan 03

Direct multi-product (monoclonal antibody) drug substance manufacturing activities in both clinical and commercial settings at the 500L and 2,750L bioreactor scales.

Chair daily:

Manufacturing Managers meeting

Cross-functional Operations Planning meeting

Additional Responsibilities:

Lead manufacturing representative during internal audits as well as pre-approval and other agency inspections.

Coordinate the introduction of process improvements, technology transfer and equipment upgrades into the manufacturing areas.

Regeneron Pharmaceuticals · Rensselaer, New York Apr 96 -Sep 00 Product Manager, PRP

Direct the toll manufacturing of a commercial vaccine intermediate, from raw materials receipt through intermediate shipping. Fermentation scale @ 3,000L.

Lead manufacturing point of contact with client.

Lead manufacturing representative during internal audits as well as pre-approval and other agency inspections.

Fermentation Manager

Direct commercial and clinical bacterial upstream manufacturing and support departments.

Acting Fermentation Supervisor, PRP

Direct daily operation of the commercial Haemophilus Influenzae BSLII Fermentation group.

Manufacturing Research Associate

Operate E. coli and Haemophilus Influenzae fermentation and downstream purification processes.

EDUCATION

New York University · University College of Arts and Sciences · Bronx, New York - Chemistry Major

Hudson Valley Community College · Troy, New York - Organic Chemistry

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