Jennifer Hwang

Spearheaded Life Cycle Management and Continuous Improvement for viral vector manufacturing (drug substance biologics). Served as Chief of Staff for Executive Director. • Established multifunctional teams including OPEX, PMO, Operations, CMOs, and MS&T and led teams through process improvement brainstorming, to project prioritization, and project execution. • Led MS&T and PD leadership in setting internal KPIs and communications structuring for report out to the Cell Therapy Senior Leadership Team on project and program progress. • Supported process comparability campaigns, risk assessments, and investigations. • Mentored emerging leaders via sponsored mentoring programs.

Led new product introduction and technology transfer from R&D to manufacturing within a matrix team for biologic and Class III (implantable) medical device products. • Managed multifunctional stakeholders throughout project phases from concept through commercial launch and post launch MSAT support. • Project lead for new product lines, primary and secondary packaging systems for biologic product, and new technologies/automation to improve existing manufacturing processes. • Responsibilities: design control, DHF, identification and development of new suppliers and new technologies, audit support, change controls, SOP and specification authoring, statistical analysis, technical analysis, problem solving, equipment and process validation, and PPQ. • Patent published for Acellular Dermal Matrix holder design. Completion of project mitigated $10-$15M annual revenue loss.

Strategized and executed product lifecycle management, new product introduction, and continuous improvement for a startup company. • Developed and oversaw a phase gate process for new product development and project prioritization. • Provided direct support to domestic and international CMOs and customers on new product development and quality improvements to existing products. • Directly managed the operations team and developed and implemented key performance metrics. • Prioritized actions as related to key performance metrics and held the teams responsible for performing according to KPIs. • Recognized by board members for transformational impact to the company culture in less than a year.

Led projects covering site wide lean six sigma transformation supporting certification to Honeywell Operating System Gold Standard. Projects included Value Stream Map, FMEA, Control Plan, Standard Work, Tier Boards, and definition and completion of high-risk Priority Number Actions. • Recognized for outstanding performance using teamwork to implement difficult changes. • Drove product and process improvements in clean room environments. • Led team members in continuous improvement projects including yield improvement, COPQ, cycle time reduction, and safety/ergonomics leading to over $1.6M annual savings • Statistical analysis to identify and implement process improvements including DOE, MSA, process capability analysis, and statistical process control. • Completed capital improvement projects to include addition of new manufacturing lines and the design, qualification, and introduction of new manufacturing technologies.

Supervisor for Class II medical device high volume manufacturing – assembly, labelling, and sterile packaging. • Supervised 78 personnel across 4 departments, increasing productivity by 40% and assuring compliance to FDA and cGMP guidelines. • Championed quality and efficiency improvement projects to include managing NCRs, 6S, root cause corrective action, and rapid problem solving.

Deployed to Afghanistan as platoon leader of 56 Soldiers during Operation Enduring Freedom. As Battalion Human Resources Officer, managed human resources and administrative functions of Army engineer battalions of over 700 Soldiers. Conducted multi-echeloned coordination to maintain battle-readiness for a unit capable of airborne deployment worldwide within 18-hours of notification. Selected by the Battalion Commander to serve as his assistant as his best staff officer. Awarded parachutist badge and 3 Army Commendation Medals. During Engineer schooling, awarded Honor Graduate for graduating in top 20% of class, first try pass on all tests, and instructor recommendation. Recommended for promotion ahead of peers and promoted three times, reaching the rank of Captain.

Dean's List

4.0 GPA