Gregory St. Louis Email and Phone Number

Primary responsibilities involved the management of analytical outsourcing activities at CROs and CMOs in support of company’s clinical stage AAV gene therapy products. Oversaw the development, transfer and qualification/ validation of analytical methods required for lot release, characterization, and stability. Job scope expanded to include the management of some manufacturing, CMC, and stability activities.• Worked effectively with internal teams to develop work scope and identify vendors.• Ensured that projects were initiated in accordance with timelines by collaborating with vendors, legal, and technical teams to establish CDAs, MSAs and SOWs/Work Orders.• Verified that project expenditures were on target by managing budgets and accruals in collaboration with Tech Ops leadership and finance team. • Created timelines and tracked progress of deliverables through dashboards and Smartsheets. Provided updates to internal team members and leadership at CMC and other program meetings.• Kept projects on track by following up with technical teams and Quality to ensure that vendor documents were reviewed and approved in a timely manner. • Spearheaded regular vendor meetings and managed the relationships between vendors and internal customers. • Ensured productive discussions by establishing agendas and facilitating CMC meetings.• Maintained manufacturing timelines at CMOs through the timely review of batch records, process specs and sampling plans.• Managed Drug Product stability program, including the review and trending of data.

Managed resources at Momenta’s primary outsourcing vendor. The vendor contract utilized up to 20 full-time employees that supported Analytical, Quality, and Drug Product activities. • Coordinated with representatives across multiple programs and functions to manage tasks and resources within the overall vendor contract. Effectively prioritized the workload to ensure the most critical activities were completed in accordance with program and company goals. • Tracked, managed, and forecasted resource use at the vendor. Summarized and presented this information to senior management to provide visibility and allow for informed, productive decision making.• Ensured alignment on vendor expenditures through effective communication and collaboration with project managers and finance team.• Developed and maintained the vendor relationship, including managing issues between the vendor and internal customers.• Spearheaded both development and GMP stability studies across multiple programs. This work included trending and presenting stability data, generating stability reports, and writing and reviewing stability sections in regulatory filings.

Oversaw development, optimization, qualification, and transfer of analytical methods for complex polysaccharide, peptide, and glycoprotein products.• Fostered strong inter-departmental relationships by representing AD on cross-functional teams focused on process development and technology transfer efforts.• Effectively managed analytical efforts in support of an FDA response that led to a product approval.• Managed and mentored junior members of AD group.• Contributed to and reviewed analytical sections for successful regulatory submissions.

Oversaw development, optimization, qualification, and transfer of analytical methods for complex polysaccharide, peptide, and glycoprotein products.

Member of the Analytical Development - Biologics group.

Member of the Analytical development - Biologics group.

Member of the Analytical Development - Biologics group.