Gregory Mueller Email & Phone Number

Indianapolis, In, Us

Indianapolis, In, Us

Indianapolis, Indiana

Focus on people/organizational leadership to ensure that the Pharmaceutical Project Management organization is providing the most value and best service to lead and advance the R&D portfolio. Managed an average of 10 team members.Partnered with stakeholders to ensure that the portfolio is appropriately resourced while balancing the development needs of my team members.Coached/mentored team members to ensure that they are supported while at the same time maximizing their growth… Show more Focus on people/organizational leadership to ensure that the Pharmaceutical Project Management organization is providing the most value and best service to lead and advance the R&D portfolio. Managed an average of 10 team members.Partnered with stakeholders to ensure that the portfolio is appropriately resourced while balancing the development needs of my team members.Coached/mentored team members to ensure that they are supported while at the same time maximizing their growth in the role as leaders and drug developers; focused on career development and sought out development opportunities for team members to maximize their growth and potential.Worked within Lead Team on organizational initiatives. Focused on talent management and ensured that we were recruiting and hiring the best diverse talent with the appropriate skills/capabilities to best meet the needs of our stakeholders and the portfolio. Show less

Project manager focused on leading cross-functional teams through the strategy, planning, and execution of CMC development plans that appropriately integrated into the broader development plan for the molecule/asset. Main representative of the CMC function on the broader asset team and influenced the asset team to ensure that the best CMC strategy/plan was recommended for leadership alignment.Led CMC technical, operational, and quality teams in the development of processes with the… Show more Project manager focused on leading cross-functional teams through the strategy, planning, and execution of CMC development plans that appropriately integrated into the broader development plan for the molecule/asset. Main representative of the CMC function on the broader asset team and influenced the asset team to ensure that the best CMC strategy/plan was recommended for leadership alignment.Led CMC technical, operational, and quality teams in the development of processes with the appropriate analytical control strategy to manufacture drug substance and drug product and ensure on-time delivery of final CT material to clinical sites. Experience leading antibody and microbial development project teams across multiple therapeutic areas to enable on-time delivery of pre-clinical, Phase 1, Phase 2 development activities within scope and on budget. Experience leading a project team in collaboration with a new fully integrated external development partner to enable the CMC development and manufacturing for an early-phase large molecule project.Created tools and resources to standardize and facilitate work activities across entire CMC project management organization.Coached/mentored colleagues and team members. Show less

Led cross-functional teams in business and process improvement initiatives within the Development, CT Manufacturing and Material Delivery, and Quality organizations to best meet the needs of stakeholders and the business. Utilized Six Sigma methodology coupled with project management principles to drive timely business improvements and ultimately business results. Coached and mentored Green Belts on their smaller scoped projects that were more functional area specific.

Developed robust and scaleable cell culture processes for several antibody projects (early-phase through pivotal phase). Instilled Quality by Design principles into experimental designs. Partnered with purification and analytical colleagues to ensure that the final drug substance would meet quality standards and specifications. Partnered with GMP technical, operations, and quality team to transfer processes into large scale manufacturing area and ensure successful production… Show more Developed robust and scaleable cell culture processes for several antibody projects (early-phase through pivotal phase). Instilled Quality by Design principles into experimental designs. Partnered with purification and analytical colleagues to ensure that the final drug substance would meet quality standards and specifications. Partnered with GMP technical, operations, and quality team to transfer processes into large scale manufacturing area and ensure successful production lots.Manufacturing Science and Technology Associate (6-month OUS short-term assignment): Transferred bench-scale processes between sites to enable a new lab to support a new GMP manufacturing facility. Developed mechanisms to simplify and ensure consistent operations by laboratory personnel. Coached/mentored new staff on cell culture principles and best practices.GMP Manufacturing Associate (one year rotational assignment): Cell culture technical lead on GMP production floor. Worked closely and collaborated with operators to ensure successful large scale bioreactor campaigns for a multitude of antibody projects. Show less

Led cell culture process development efforts on several antibody projects utilizing statistical experimental designs. Led technology transfer activities of cell culture processes to both non-GMP and GMP manufacturing to enable toxicology and CT material supply, Focused efforts on improving our antibody platform process, which included cell culture medium and feed development/optimization. Conducted bioreactor characterization studies (e.g. kLa modeling, mixing) to ensure seamless technology… Show more Led cell culture process development efforts on several antibody projects utilizing statistical experimental designs. Led technology transfer activities of cell culture processes to both non-GMP and GMP manufacturing to enable toxicology and CT material supply, Focused efforts on improving our antibody platform process, which included cell culture medium and feed development/optimization. Conducted bioreactor characterization studies (e.g. kLa modeling, mixing) to ensure seamless technology transfer from bench scale to production scale. Show less

M.S., Chemical Engineering

B.S., Chemical Engineering

Biochemical Engineering option