1. Janille Watkins
janille.w1@gmail.com | www.linkedin.com/in/janille-watkins
4304 Dell Rd. Apt. K, Lansing, MI 48911
517-719-1289
OPERATIONS EXECUTIVE
Determined and motivated operations and quality management executive with expertise in manufacturing
with cGMP standards and in-process quality enhancement focused on driving continuous improvements,
employee development and team leadership. Experienced in using Lean Manufacturing to reduce costs
and streamline production processes to deliver quality products to meet customers’ expectations and
achieve company goals.
AREAS OF EXPERTISE
Operations Management | In Process Quality | Lean Manufacturing | Quality Training | Cost Reduction
Process Improvement | Kaizen | Kanban | JIT | Gemba Walks | Audits & Inspections | Information
Mapping | Process Procedure Mapping (PPM)| Investigations & Non-Conforming Events |5S |SAP
Value Stream Mapping |Standard Operating Procedure (SOP) Creation| Standardized Work
EXPERIENCE
EMERGENT BIOSOLUTIONS - Lansing, MI 2003-2016
Supervisor, Operations
Biodefense Division (2013 – November 2016)
Oversaw the on-going validated state of non-commercial and commercial cGMP manufacturing
process for production of Anthrax vaccine to achieve revenue of $520 million by managing a team
of 15 to 25 direct reports in daily production task execution.
Business Responsibilities
● Wrote and delivered performance reviews through Integrated Performance Management
Process (IPMP).
● Balanced shift levels through staffing and resource allocation models ensuring production
outputs of 19 sublots per week.
● Created Individual Development Plans (IDP) for direct reports that helped reach short and
long-term goals, as well as improve current job performance.
● Facilitated shift and management meetings ensuring the appropriate level of communication
is disseminated to the subsequent shift and impacted support departments regarding process
and equipment status.
● Promoted decision making to the department, empowering direct reports to make level-
appropriate decisions.
● Provided resources and subject matter expert (SME) input that support continuous
improvement, capital and corporate initiatives.
● Ensured personnel fully supported compliance-based activities by maintaining current
training requirements.
Technical Responsibilities
● Participated and provided SME resources in support of all regulatory audits and technical
discussions during FDA inspections.
● Ensured department compliance with all cGMP regulations as well as other areas of
mandatory regulatory oversight.

2. Janille Watkins 517-719-1289 | janille.w1@gmail.com Page 2 of 2
● Process performance monitoring for compliance with all applicable rules and regulations of
the Pharmaceutical/ Biotech industry. This includes FDA regulations such as cGMP, GDP,
and EH&S regulations.
● Supported the Quality Corrective Action Review Board process, by investigating non-
conforming events for root causes,assessing impacts and implementing durable corrective
and preventive actions preventing future audits.
● Implemented Voice of Customer data collection process leading to a better understanding of
customer needs and issues which help drive resolution.
● Assigned and maintained biennial document revisions to SMEs to ensure completion within
30 days of the assigned due date.
Culture Management and Employee Development
● Established and maintained routine management tools and standards assuring that direct
reports are utilizing common tools to track resources,time coding, and performance.
● Created and implemented a team charter to select and develop technicians that will
contribute to a quality mindset of the team while achieving production targets through a
successfuleducational experience and the onboarding program.
Team Leader (2010-2013)
Independently made process decisionswhile directing the activities of manufacturing
technicians,ensuring production schedule requirements were met.
● Completed assessments of required performance management for technicians.
● Ensured proper execution of product development protocols, technical studies and
corrective/preventive maintenance.
● Management of documentation and control of ambient exposure process time for drug
product, final filled product, and finished product.
● Coordinated and communicated scheduling of support department requirements (preventive
and corrective equipment maintenance, validation activities, and technical studies).
● Real time Batch Production Record (BPR) review for accuracy of calculations, data entry
and completeness of process signature steps.
Senior Technician (2005-2010)
Technician (2003-2005)
EDUCATION
MICHIGAN STATE UNIVERSITY East Lansing, MI
Bachelor of Science, Health Sciences
PROFESSIONAL DEVELOPMENT
 Partners in Leadership.
 Conflict Management.
 Employment Law for Managers.
 Train the Trainer.
 Management Coaching Program.
 Human Error Reduction.
 Situational Leadership II.
 American Management Association Trainings; Moving From an Operational Manger to a Strategic Leader,
Building Better Work Relationships: New Techniques for Results-Oriented Communication.