Tanya Chavez-Cropp

****Bartwood Dr

919-***-****

Raleigh, NC 27613

acf19v@r.postjobfree.com

CAREER SUMMARY

M.S. chemical engineer with nineteen years of experience in the vaccine,

biotechnology and semiconductor industries. More than nine years of

experience managing direct reports, engineering project team members,

interns and contractors. Expertise in managing multiple large projects at

one time, improving equipment and process control, root cause analysis, and

handling emergencies. Recognized strengths include leadership, teamwork,

problem solving and achieving results.

SKILLS SUMMARY

OPERATIONAL EFFECIENCY: TPS, PM optimization, RCM, ASTM2500, Lean, PDCA,

SLA, ACT and Catalyst

COMMERCIALIZATION EFFORTS: New product introduction, Tech transfer, Space

planning/layout, Facility design, Vendor selection, Defining equipment

specifications, URS, FRS, DDS, PFD and P&ID development

ENGINEERING PROCESSES: cGMP, CCMS, TrackWise, Maximo, LOTO, PM, SOP, MP,

NC, CAPA, EH&S, JHA, Safety audits, IQ, OQ, PQ, Periodic monitoring, FMEA,

RPN, DOE, SAT, FAT, Regulatory support, QA and Val requirements, Gap

analysis

PROCESS EQUIPMENT: Roller Bottle cell culture, Column chromatography,

Membrane chromatography, Column packing, Cell culture, UF/DF, Viral and

Depth Filtration, Buffer prep, Buffer hold, Autoclave, Integrity test,

Process analytical technology, CIP, Biowaste

BIOTECH PROCESSES: Vaccine, Monoclonal Antibody, Microbial, Mammalian,

Multi-host

PROFESSIONAL EXPERIENCE

MERCK MMD, Durham, NC

2011-present

Viral Vaccine Technology & Engineering

Director Engineering

2013-present

Lead the technology transfer/strategic project team for the site. The

site consists of an 18 robot bulk manufacturing facility and a two

filling line form fill facility. Accountable for product tech

transfers into the form fill facility and 70% throughput increase over

basis of design in the bulk facility. Manage 23 full time employees, 4

contractors and report to the Executive Director of Engineering.

. Guided site and franchise to align on strategic priorities.

Established achievable goals and a robust plan to realize those goals.

Influenced and gained consensus on strategic project prioritization

and timing up through Senior Vice President of Operations.

Subsequently guided team to deliver 100% on target milestones.

. Doubled throughput of existing bulk facility one month ahead of

schedule through process improvements and Lean methodology.

Maintained safety, deviation, yield and process performance metrics

throughout the ramp-up in production. Achieved success through

focused and innovative approaches to collaboration, communication,

and engagement with the Integrated Process Team.

. In form fill facility, successfully steered MMR from PPQ execution,

submittal of license applications in two countries, application

support during PAI in two countries, and EU approval in less than one

year (four months ahead of target). Additionally, executed

development runs to solidify process in second tech transfer product,

minimized bulk usage, and began PPQ execution one month ahead of

original plan. Frequently overcame substantial challenges and

maintained critical milestone timeline by encouraging creative

thinking, resilience, and holding my team and other teams accountable

for results.

. Site representative for six above site technical and supply chain

governing groups. My contribution solidified our relationship with

the sending site and built confidence and trust in Durham progress.

. Integrated the bulk and form fill tech transfer teams which had

previously worked independently. Set expectations for team to share

best practices and work together on items such as tech transfer

standard work, project management, and automation requirement

specifications. Held frequent team meetings and off site gatherings

so team could build relationships and become a cohesive team.

. In collaboration with Executive Director, managed annual department

budget, department hiring, succession planning, long range operating

plans, and actions to improve Voice of Customer survey results.

Associate Director Engineering

2011-2012

Lead the capacity expansion branch of the technology team in a 12

Robot roller bottle cell culture facility. Accountable for two of the

seven 2012 goals for the bulk facility: expand the manufacturing

facility by 50% through capital expansion and increase throughput of

existing facility by 70% through process improvements and Lean

methodology. Manage six direct reports and three contractors, report

to the Director of Engineering.

. Startup Lead of a six robot facility expansion. Partnered with

Global Engineering Services in the facility design,

qualification, startup and process demonstration activities.

Served as bridge between the project team and site

Manufacturing, Quality, Automation, Plant Engineering and

Validation teams to ensure process and operational requirements

were fully understood and processes were validated to be

reliable, consistent and meet cGMP standards.

. Significantly accelerated project schedule. Completed OQ

activities 9 months ahead of original target. Achieved

acceleration via creative thinking that allowed water runs and

engineering runs to occur prior to combining the expansion and

existing facility. Successfully held functions accountable for

deliverables by utilizing effective methods of prioritization,

tracking and appropriate elevation.

. Lead of bulk throughput improvement effort with goal of

increasing throughput of facility utilizing Lean methods and

little to no capital expenditures. Project started at concept

phase. Modeled facility throughput and designed scenarios to

optimize equipment and operator utilization. Analyzed

theoretical max output and actual output of all equipment,

utilities, warehouse, vendors, and support infrastructure with a

focus on "go see". Identified bottlenecks to achieving modeled

capacity. Initiated and completed operational efficiency

projects to relieve bottlenecks and eliminate waste. Achieved

76% increase in throughput over startup production rate and on

track to increase throughput 70% over basis of design by 2015.

. Focus on personal and team development. Hired and led team of

six engineers to achieve the above goals with passion and

optimism. Inspire trust and respect by personally doing what I

ask of others. Routinely give and solicit feedback to improve

team communication, empowerment and accomplishments. Actively

pursue improvement opportunities by participating in programs

such as Merck's six month "Breakthrough Leadership" program.

SHIRE HGT, Lexington, MA

2009-2011

Engineering

Manager Engineering

2009-2011

Lead the engineering function which supports the manufacture of

commercial and clinical bio-tech products in a 10,000 roller bottle

cell culture facility. Represent the engineering function to other

functional groups such as Quality, Validation, Process Development,

Manufacturing, Facilities, and Engineering at two other sites. Ensure

the quality of work and appropriate engineering resources are in place

to support the design and implementation of Capital Projects as well

as 24/7 manufacturing operations. This position reports to the

Senior Director of Engineering and is a key member of the Site

Steering Committee.

. Plan, organize, coordinate and communicate the work of the site

engineering team which consists of process, CIP and automation

engineers. Team is accountable for all utility and process

equipment within the Roller Bottle facility. Utilize knowledge

of biotech processing methods, equipment and validation to

provide guidance and technical advice to direct reports as

needed.

. Key member of Site Steering Team responsible for developing site

goals and objectives, defining annual capital projects and

budget, meeting plant metrics and regulatory compliance

commitments. Joined the team midway through the process of

successfully constructing a new Roller Bottle facility, bringing

it through engineering runs, process validation runs, and FDA

Pre Approval Inspection within 1.5 years.

. Championed creation of a multi-disciplinary Project

Prioritization team to fill unmet site need of communicating,

coordinating and prioritizing all site projects and initiatives.

Solicited team member feedback to refine the process and add

scope to the meeting.

. Significantly increased the level of engagement and development

of my staff by encouraging them to implement their own ideas for

cross functional collaboration and by working with engineering

managers at other sites to create development opportunities.

AMGEN INC., Boulder, CO

2003-2009

Manufacturing

Manager Engineering/Senior Engineer

2005-2009

Created job descriptions, interviewed, hired, trained, supervised,

guided development and provided evaluations for full time employees.

Championed opportunities for change by representing the plant

engineering group in key commercialization efforts and lean

manufacturing initiatives.

. Managed four direct reports, two senior engineers and two

engineers. Team was accountable for all Purification equipment

and processes in a new product introduction facility responsible

for the commercialization of three peptibody and one monoclonal

antibody product. Purification operations range in scale from

45 cm to 160 cm column chromatography. Provided guidance and

technical advice to direct reports as needed.

. Responsible for cascading EH&S information to Plant Engineering

(PE) group monthly, leading PE managers in converting site goals

into actionable objectives and plans for the PE team, leading PE

management in developing and executing operational improvements

within our group, leading PE efforts in reducing the overall

cost of maintenance at Amgen CO (both Longmont and Boulder

sites) and representing PE on the compliance "Audits and

Stakeholders" team.

. Lead engineer in the technical transfer of a phase II clinical

product into GMP manufacturing operations. Core team was

comprised of cross site and cross functional members and proved

that the facility equipment and utilities were capable of

producing the molecule with minimal modifications to the plant.

Made key equipment and processing decisions in order to meet

budget and schedule goals.

. Out of 25 engineers and three senior engineering managers, was

selected by the Director of Engineering to represent the PE

department on a $38M expansion project. This role is typically

assumed by the Director, but was granted to me because of

recognized leadership abilities and expertise on all

purification process equipment. Team developed detailed design

of the building expansion, P&IDs, equipment specifications, user

requirement specifications, process hazard analysis and

validation plans. Influenced and negotiated between the project

team members and the system owner group which ultimately allowed

all design to be complete and all process equipment to be

purchased on schedule and within budget.

. Catalyst for change in engineering group. Identified need to

cross-train engineers on equipment and need for managerial

development opportunities. Proposed a new organizational

structure which enhanced knowledge transfer, training,

individual development and attention to global initiatives. As

a result, was selected to be the first senior engineer to have

direct reports in the Plant Engineering (PE) group. Efforts and

success have led to the duplication of this model under other

senior engineers.

. In charge of team that partnered with site leadership and VP of

Colorado Operations to help incorporate and capitalize on

diversity as a way to deliver better business results.

Consequently, site leadership adopted our recommendations on how

to leverage diversity thinking into strategies for achieving

2007 site goals.

Senior Engineer

2003-2005

Troubleshot and determined root cause of problems and provided

optimization strategies for four product lines in a multi-host, FDA

regulated cGMP manufacturing facility. Ensured a large number of

highly complex pieces of purification process equipment and systems

remained within their validated state and regulatory compliance. Led

system improvement efforts in conjunction with Manufacturing, Process

Development, Maintenance, Quality Assurance, Regulatory Compliance and

Validation.

. Initiated and led cross departmental team in proactively

reviewing every step and instruction in 12 chromatography

control recipes that were historically riddled with errors.

Managed 14 Change Control records simultaneously to fix the

errors prior to production campaign. As a result, there were

zero production delays, zero non-conformances and zero manual

manipulations needed.

. Executed introduction of two new products into Purification

equipment, making our site the first and only multi-host

facility in the world. This included Failure Mode and Effect

Analysis, new equipment evaluations and PFD/P&ID/automation

recipe development.

. Anticipated and prevented potential problem of missing critical

deadline by requesting and managing a project team of two

contract engineers and two Amgen engineers. Trained team

members, developed schedules, set intermediate goals, motivated

the team and turned company goal of delivering a product on time

into actionable objectives and plans. By effectively utilizing

this team, became the only plant engineer to validate all

changes needed for all three products made in the facility at

the time. This comprehensive approach to new product

introduction allowed the company to switch products in an FDA

regulated environment in real time fashion, effectively saving

four weeks of engineering time in four departments every time

products are switched.

. Innovated solutions to problems that had loosely defined

objectives and required investigation of a large number of

variables. For example, developed a new method for transferring

product from one piece of equipment to another that eliminated

chronic problem of product foaming.

. Ensured process equipment systems remained within their

validated state by providing technical reviews of system

evaluations, validation protocols, change evaluations and

manufacturing documents.

. Led product impact and root cause assessments for nonconformance

investigations.

AGILENT TECHNOLOGIES (formerly Hewlett Packard)

1995-2003

Integrated Circuit Business Division, Fort Collins, Colorado

Research and Development Engineer

Manufacturing Group (Back Half)

1999-2003

Introduced new technology into ISO9000 and ISO14000 high volume

manufacturing facility. Extensive experience with design of

experiments, qualification, validation, and documentation in a heavily

regulated industry. Developed, characterized, implemented, monitored

and improved device level integrated circuit processes.

. Created and led a team of six process engineers and two design

engineers in determining the feasibility of using in-house

equipment to manufacture a new optical lens product. Project

ultimately reduced cost from $20/lens to $0.10/lens in five

months.

. Out of 50+ engineers, was selected to be on a team of four to

introduce a cutting edge Gallium Arsenide process to our

facility. The technology, process, tool set, and wafer handling

was entirely new to Agilent. Learned the technology and took it

from concept through design, development, validation and finally

full manufacturing release. As a result, we were able to enter

new markets with new products and gain new customers.

. Increased tool utilization from 80% to 90% by analyzing and

revamping entire set of preventative maintenance and operational

procedures with a team of technicians and operators.

. One of three company representatives in national forum to reduce

global warming gas emissions to 10% less than 1995 levels by

2010 (goal established by World Semiconductor Council).

Manufacturing Development Engineer

Manufacturing Group (Front Half)

1995-1999

Troubleshot equipment and processes, led cross-functional teams,

developed new processes, improved process control, upgraded and

purchased equipment, and maintained solid working relations with

operators, technicians, vendors, and facilities engineers so that our

semiconductor manufacturing line ran continually and metrics such as

cycle time and yield improved.

. Coordinated selection, purchase, acceptance, installation,

validation, and startup of new generation vertical furnaces.

Managed the project so all scheduling goals were met and

capacity was increased in time for a large ramp in orders.

. Created an alert/alarm system for furnaces. Tracking data from

this system allowed root cause of problems to be identified and

fixed before aborts occurred. The number of alarms decreased

from 60% to 10% and aborts were virtually eliminated. This

decreased the amount of engineering, maintenance, and operator

time used in firefighting problems as well as reduced the amount

of scrapped product.

. Standardized operation of 24 horizontal furnaces thus improving

process control and allowing our product to consistently meet

quality specifications.

. Optimized maintenance procedures by forming a team of

technicians so equipment is returned to operators fully

functional. This significantly increased furnace uptime and

decreased the need for engineering intervention after

maintenance.

. Led a team of operators and engineers in creating trouble-

shooting guides for the horizontal furnaces. This improved

operator performance by empowering them to qualify tools after

maintenance and solve a multitude of problems before needing

engineering intervention.

ADDITIONAL EXPERIENCE

Coors Brewing Company, Ribozyme Pharmaceuticals Inc., Sandia National

Laboratories, Mobil Exploration and Production U.S.

EDUCATION

UNIVERSITY OF COLORADO, Boulder, Colorado

1994

MS in Chemical Engineering, Specialization in Biotechnology

NEW MEXICO STATE UNIVERSITY, Las Cruces, NM

1991

BS in Chemical Engineering

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