Manager TS/MS API EM Resume Example Company Name

MANAGER TS/MS- API EM

Summary

Results-driven manufacturing and quality professional with 20 years of pharmaceutical and biotech experience in science and safety. Broad leadership experience in Quality Control, Technical Services/ Manufacturing Science, and Safety with a proven track record of developing individuals to help them achieve significant milestones to meet site priorities and progress in their career. Demonstrated success leading site-wide initiatives to improve capability and encourage engagement.

Skills

M&Q Leadership and Mentorship
Strong Understanding of Internal and External Manufacturing Standards for Operational Excellence

Quality and Safety Mindset
Proficient with Trackwise, eLN, GMARs, eCIR, Teams

Experience

Manager TS/MS- API EM, Company Name, March 2015-CurrentCity, State

Managed a team of front line and laboratory scientists responsible for the technical oversight of multiple, commercial, large molecule products manufactured externally. Assured quality medicine was produced safely per the GCMSs and MSOEs. Standardized the front line and lab science roles (ex. creation of technical document templates, ScLT facilitation, application of a Risk Based Oversight Model, and implementation of weekly data reviews).
Drove multiple site initiatives to completion. Created the API EM On Boarding Program for the site. Led MSOE assessments. Core member of LEAN initiatives for the site (ex. site huddle board development, lab 5S, LSW). Primary technical rep for development of the RBO process.
Led the API EM admin space and new lab construction project for the site. Developed user requirements to assure functionality, flexibility, room for expansion, and safety by design. Key contact for the project manager and intermediary between the lead team and space planning teams.
Improved site safety culture (culture score improvement from 46 to 80 over 5 yrs) by implementing behavioral safety programs, leading Safety Team (3 yrs), facilitating HSE LT, developing a lab safety program, rewarding and recognizing individuals for safety engagement, and developing the HSE Plan for multiple years. Role of MST Liaison for site through the pandemic by being the primary communicator of IST and Medical Team updates back to all API EM members and conducting BCP exercises.
MQSRLT (Manufacturing & Science Recruiting Lead Team) member for 6 years with role of management sponsor (oversight of intern program, campus recruiting, interviewing, Point Captain point of contact, and contribution to MPC presentation updates.
API EM Diversity and Inclusion Co-Lead. Developed and completed actions to improve Maturity Model scores (ex. introduction of metrics, promoted Global D&I events, hosted local inclusion events)

Behavioral Safety Consultant- IAPI, Company Name, August 2012-March 2015City, State

Worked closely with the Site Head, Lead Team, HR Business Partner, and all functions across the site of 750 on leadership development and safety culture initiatives.
Benchmarked with internal sites, HR L&D, and external companies to determine best behavioral safety programs and leadership development courses to implement at the site. Implemented various safety programs and developed or facilitated various leadership skills courses across the site (ex. SafeStart, FELT Leadership, Emotional Intelligence, Leadership Stand Downs, safety shares, metrics, alerts)
Managed small group of HSE professionals to improve safety programs across all safety aspects (ex. LOTO, Confined Space Entry, Emergency Response). Coordinated safe production shutdown and start-ups. Active Flow and Process Team safety rep for both production facilities.
Lead coordinator for the 1st API EM Family day. Created subteams for activities, food, security, and safety. Managed budget and communicate between subteams and lead team. Also, coordinated the 1st annual IAPI Tree Lighting.

QC Leadership- IAPI, Company Name, October 2003-August 2012City, State

Team Leader for multiple labs/lab technologies over ~10 years. Led chemists and technicians in the In-Process analytical chemistry lab during day and night shifts, led the Immunoassay and bulk API lab, led the Micro/Endotoxin lab, and led the site Water. In all cases, facilitated the global audit walk throughs (some direct agency interactions for specific lab equipment and deviations) and participated in backroom and ready room. Partnered with Operations to minimize impact to production as a result of QC delays.
Worked with individuals on development plans, performance management and coaching, and career movement. Created a teamwork and operational excellence recognition program.
As QC Operations Coordinator (Operational Excellence Role), managed a small group of flexible chemists who worked across all of the QC labs. I created capacity and capability models for the labs, worked with operations directors to create sample cycle time contracts, provided result and deviation status updates at daily process team, and tracked and presented QC metrics.
M&Q Science Summer Internship Co-Coordinator where we developed the program for M&Q. We established training for supervisors and mentors, determined events/tours/L&Ls for the interns, influenced projects, paired interns, interviewed, and collaborated with MQSRLT, MCP management sponsors, HR, and supervisors to assure a successful summer.

Education and Training

Bachelor of ScienceBiology, , , Butler University, , CityStateMay 2000

Resume Overview

School Attended

Butler University

Job Titles Held:

Manager TS/MS- API EM
Behavioral Safety Consultant- IAPI
QC Leadership- IAPI

Degrees

Bachelor of Science

Manager TS/MS- API EM Resume Example

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