Amber Emmons, Pmp Email & Phone Number

Bloomington , Indiana, Us

Services Include (not limited to):- Complimentary initial consultation and price proposal development - Project Management: CDMO to client or vice versa - Scope of Work drafting and execution (including timelines, budget etc.) - Onboarding of new projects/technical transfers - Management of development, clinical, PPQ, and/or commercial/launch activities- Special Projects (i.e. packaging, rapid launch into multiple countries, process improvement)

Somerset, Nj, Us

•Member of the Site Senior Leadership team, ensuring strategic planning, customer delivery and cross functional partnership for a site of nearly 3700+ employees. Collaborate in identifying and implementing best in class processes to improve the employee and customer experience, establish and drive key performance indicators and engage in site decisions to meet business objectives.•Build strategic relationships with a portfolio of development, clinical and commercial accounts, creating the highest level of customer service, while advocating for our customers and patients. Lead teams in mitigating risks, issue resolution, and collaboration with cross-functional leadership to drive On-Time Delivery of key milestones. •Lead Project Management team of ~50 team members, training and coaching through example taking a strategic, forward-thinking approach to proactively manage accounts within a fast-paced demand and execution environment.•Demonstrate strong financial stewardship by monitoring clinical and commercial contract forecast compliance, capturing revenue potential. Responsible for department financial and resource forecast and budget.•Directly support technical transfer of multiple Covid Vaccines and treatments in unprecedented industry timelines, delivering over 800M doses for the US Government and world-wide distribution.

Somerset, Nj, Us

•Support an ever-growing portfolio of programs while driving strategic initiatives to continuously evolve and grow the business, leveraging our global Biologics network•Collaborate with cross-functional, site and extended leadership teams to drive and improve project and portfolio management across the Bloomington site and Catalent network•Effectively manage, mentor and develop a team of 8 or more Project Managers, including recruiting and onboarding through a season of high turnover, a global pandemic and expedited facility growth.•Monitor team members’ projects, assist in developing risk mitigation strategies and resolving issues, escalating as necessary to ensure on time delivery of client and facility milestones•Collaborate in developing new Project Management department training and onboarding curriculum, adapting and modifying as the team transitioned to a work from home environment•Serve as department management lead for QuickBase, NPI forecasting, Biologics PRM and Op Mech preparation

Somerset, Nj, Us

Sr. Project Manager / Project Manager (February 2016 – February 2019)•Managed through transition phase during acquisition of Cook Pharmica by Catalent Pharma Solutions •Portfolio lead for top strategic customer in Catalent, Bloomington, encompassing complex matrix of more than twenty molecules, supporting tech transfer, process validation and commercial launch •Manage cross functional team, ensuring successful completion of client and facility deliverables through effective planning and risk mitigation •Coordinate production and release of >100 clinical, commercial and validation batches annually to meet customer requirements with a patient first mentality•Collaborate with Business Development and Operations Planning to ensure forecast accuracy and schedule adherence through continuous improvement initiatives•Manage high profile, fast-paced project, balancing stakeholder expectations and communication among all personnel levels•Completion of Emerging Leaders (LEAD), Catalent Bloomington’s leadership development program

Deerfield, Illinois, Us

•Facility EMS Leader for Lean Academy; prepare and facilitate annual Lean Academy for all Bloomington employees•Responsible for the Non-conformance and CAPA system management, project lead for migration to new TrackWise management•Manage customer project quality updates and reviews with all levels of management •Author, and review critical investigations as the Quality subject matter expert•Represent customers in GMP inspections for Regulatory Agencies world wide•Identify and lead continuous improvement activities to maximize business results

Deerfield, Illinois, Us

•Manage timelines and deliverables for client specific projects, including analytical testing and stability studies•Assist customers with determination of finished product testing and stability requirements •Author / draft Quality Control Master Documents, Stability Project Plans, Stability Quotes and review Master Batch Records, Process Validation protocols, regulatory submissions and Client SOPs•Author exception reports and lab investigations

Deerfield, Illinois, Us

•Manage production of pharmaceutical products for commercial and clinical clients through tech transfer, process validation, commercial launch•Project lead for key commercial project - expedited vaccine campaign delivering 7M+ units in under 3month period•Lead project team in defining strategies, developing goals, assigning project tasks •Plan, monitor and ensure completion of all project deliverables / milestones.•Manage internal and client satisfaction by managing expectations efficiently

Louisville, Ky, Us

•Aid in the process of ensuring the protection of human subjects in clinical research•Assist research investigators and coordinators in abiding by strict federal regulations •Prepare and present study information to the Internal Review Board•Process correspondence between Internal Review Board and investigators

Hamilton, Oh, Us

•Complete quarterly reports for the US Department of Labor, following stringent federal grant guidelines•Serve as Case Manager to clients under the Federal Welfare to Work Grant•Co-develop Job Skills training program for welfare clients transitioning into the work force•Administer creative problem-solving methods to assist clients with removing personal barriers•Received Employee of the Year award for excellence in service as a recent college graduate

Certificate, Managing In The Life Sciences

Ba, Psychology And Criminal Justice