Elliott L. Smalls, Jr. **** Fox Circle Perry hall, MD 21128

Phone: 443-***-****

OBJECTIVE:

Seeking a management position within a Pharmaceutical / Biotech organization utilizing my diverse business

experience with proven organization, problem-solving, technical and interpersonal skills.

AREAS OF EXPERTISE:

•Computer Proficient

•Researching

•Detail Oriented

•Technically and Mechanically Inclined

•SAP SME

•Lead Investigator Trained

•Project management

•Yellow and Green Belt Certified

WORK EXPERIENCE:

Medimmune/AstraZeneca, Frederick, MD

Process Lead Feb 2018-Present

•Responsible for operation of Upstream / Downstream / Central services processing equipment according to established SOPs and driving continuous improvement opportunities. The Process Lead is the operational subject matter expert to represent the shift and/or functional area as needed for investigations, CAPAs, and receipt of tech transfer information. The position reports to the area manager with dotted-line responsibilities to the shift supervisor to support daily manufacturing and in-direct floor support activities which include:

•Direct on floor support (50-70% time on shop floor)

•Qualified in Lead Technician duties and on-floor coaching

•On the floor manufacturing execution as needed by shift supervisor

•Shift representative for shop floor investigations and CAPA execution

•In-direct floor support (30-50% time for support)

•Trend process performance and data trending to assess batch performance

•Lead and engage in continuous improvement projects

•Author, review and approve batch records and direct SOPs for manufacturing

•Final review of completed manufacturing documentation per compliance standards and established timelines

•Logbook reviews, where applicable

•Assess training competency of and provide training to shift personnel

•First line of defense for process and equipment troubleshooting on the shift

Elliott Smalls, Jr. Page 2

•Identify and execute standardized work and process improvements

Medimmune/AstraZeneca, Frederick, MD

Manufacturing Supervisor Jan 2013- Feb 2018

•Daily supervising and performing on-the-floor operations pertaining to biologics manufacture in a cGMP environment (70-80% time on shop floor)

•Coaching, counselling, training/development, discipline and recognition of direct staff, including performing annual performance reviews

•Ensuring performance of all process steps specific to the phase or stage of operation (e.g. upstream, downstream, support)

•Coach staff and intervene during operations when required to achieve on-floor performance expectations

•Ownership of Tier 1, shift change meetings to coordinate cross-functional resource allocation needs for issues identified and maintain production targets

•Executing production and resource schedule against operational plan

•Daily off-floor support provided (20-30% off floor coorindation)

•Generating SOPs, MPRs, and SPRs for equipment and procedures used in routine biologics manufacture.

•Monitoring and creating documents and/or spreadsheets to support business reporting requirements

•Final review of completed manufacturing documentation per compliance standards and established timelines

•Collaborating with Manufacturing Process Lead to resolve problems, identifying root cause, and proposing process improvements through clear communication to senior management

•Participating and/or leading multi-functional project teams, as necessary

•Participate in helping to evaluate and establish potential new interdepartmental procedures and practices

Medimmune, Frederick, MD

Lead Production Technician May 2011-Jan 2013

•Generate SOPs, MPRs, and SPRs for equipment and procedures used in the manufacture of biological based products

•Execution of validation protocols as required

•Execute projects with minimal instruction and management oversight.

•Assigning daily tasks to production technicians pertaining to manufacture of biologica based products

•Complete manufacturing documentation per approved procedures Includes reviewing documentation for completeness and accuracy per established timelines

•Act as qualified trainer of those with less experience.

•In-direct supervision of production technicians.

•Provides input into annual performance evaluations of production technicians as applicable.

Elliott Smalls, Jr. Page 3

•Investigate and resolve problems. Clear and concise communication to Process Lead and Supervision/Management

•Coordination of production tasks to meet assigned schedule

•Good organizational skills

•Basic first-line management skills for daily operation

•Situational Leadership

•Decision making skills

Aerotek Scientific / Medimmune, Frederick, MD

Production Technician/Central Services December 2009 – May 2011

•Trained in CIP, COP, SOP and SIP of fixed and portable tanks as well as flex hose circuits.

•Completely trained in all areas: Media Prep, Buffer Prep, Washers and

•Autoclaves.

•Executed good documentation practices on all GMP and Shakedown runs.

•Full working knowledge of the SAP inventory system.

•Full working knowledge of the Biosafety cabinet using Aseptic

•Technique.

•Extensive GMP and SOP training using LMS computer based software.

•Trained in all current Standard operating procedures (SOP's).

•Full working knowledge of HMI system.

•Extensive logbook use and control.

•Execution of validation protocols for SIP PQ's for start-up.

•Fully trained in filter integrity testing using the IT4 and IT4N Filter

•Integrity tester and programming them with the various filter test recipes.

•Trained new and current employees in all areas of Central Services.

•SOP revisions and Aegis qualified

•Subject matter expert (SME) on the writing of Medi 545 Solution Preparation Records for the Buffer prep process.

ISP Pharma Technologies, Columbia MD

Pharma Tech III June 2006 - December 2009

•Able to set-up, operate and maintain processing equipment.

•Research and Development work for different drug companies by using various pieces of equipment.

•Full working knowledge of PMA for High Shear Granulation.

•Full working knowledge of Fluid Bed Processor for Drying, Coating and

•Drug Layering.

•Extensive solution preparation experience involving aqueous and organic

•Solvents for immediate, modified/sustained and enteric release coating.

•Full working knowledge of Close Cycle Utility Spray Dryer, including

•Set-up, operation and troubleshooting.

•Full working knowledge of 'Wonder Ware' computer software.

•Completion and Reviewing of Batch Records.

Elliott Smalls, Jr. Page 4

•Deviation/Investigation Reports.

•Use and control of Log book.

•Cleaning Verification. Complete and maintain a variety of documents

•Required of a GMP operation.

•Execute project tasks and follow detailed directions, both written and

•Oral.

•Use knowledge of equipment in determining an effective plan to complete

assigned task.

Niro/ISP Pharma Technologies, Columbia MD

Pharma Tech I May 2003 - June 2006

•Use and control of Log book.

•Execute project tasks and follow detailed directions, both written and

•Oral.

•Use knowledge of equipment in determining an effective plan to complete

•Assigned task.

•Extensive solution preparation experience involving aqueous and organic

•Solvents for immediate, modified/sustained and enteric release coating.

•Completion and Reviewing of Batch Records.

•Use and control of Log book.

Specific Expertise with:

•Electronic Micrometer and Caliper

•Schleuniger 8M Tablet Tester

•Friability Tester

•Statistical Control System (SCQ14)

•Sartorious Moisture Analyzer MA35

•Isotemp Model 146E Low Temperature Incubators

•Isotemp Vacuum Oven (Model 280A)

•Accumet AR50 ph Meter, and * (Fluid bed Multi Processor) Mp1, MP2/3, MP4/5, MP6, MP8

•(Pharma Matrix) PMA65, PMA300, PMA600, PMA1200

•(Quadro Comil) 196-S, 194-S, 197-S

•(Portable Spray Dryer) PSD2, PSD4, PSD6, SD Micro, Mobile Miner Spray

Dryer

•Spheronizer S-450M, Sweco (Vibro-energy), Separator LS-24, and LS-48,

•SP-1/GP1 Multi-processor, Zanasi 40F Capsule Filler, Mini Filler for

•Encapsulation

•TC200 Capsule Polisher

•HT AP38MSU Tablet Press, 6D Hardness Tester, Calibers, EF-2 Friabilator

•24'/36' Compulab Tablet Coater, Beta Tablet Press

•PPC Commander, Galley Bin Blender, Mini Galley Blender, Moisture

Machine, and Scales

•SP-1/GP1 Multiprocessor

•Biochem Safety Cabinet and fume hoods

•Micro Osmometer

•Mettler Toledo Conductivity Meter

•Thornton Max moisture analyzer

Elliott Smalls, Jr. Page 5

Procter & Gamble, Hunt Valley, Maryland

Production Technician Jan 1997-Aug 2000

•Extensive GMP and SOP training

•Pre-weighed all components (liquid and dry) pertaining to all batching areas of lipsticks, mascara, foundation and Noxzema for the Max Factor and Cover Girl lines.

•Worked in all areas of processing for batching lipsticks, mascara, and Noxzema.

•Trained on various computer based scale and process programs.

•Valve inspection, removal and installation.

Procter & Gamble, Hunt Valley, Maryland

Pre-weigh Coordinator Aug 2000-May 2003

•Coordinator of Pre-weigh Department of Liquid Processing.

•Supervised 8-12 individuals per shift on all aspects of the liquid processing department.

•Organized pre-weigh schedule for all batching areas for the Max Factor, Cover Girl and Noxzema lines.

•Trained all new employees on computer programs and computerized scales.

•Worked with all aspects of inventory control.

EDUCATION

•Graduated from Dulaney High School, Timonium, Maryland, GPA 3.7

•2 yrs. at Purdue University on full athletic Scholarship (Basketball). Computer Science Major

•Graduated from ACTT (Advanced Computer Technology Training). Received Comptia A+ and Networking Certifications.

COMPUTER SKILL

•MS Office

•Power Point

•Excel

•Publisher

•Word

•Outlook

•Trackwise

Contact this candidate