Benjamin M. Email & Phone Number

Portage, MI, US

New York, New York, US

• Leading an organization of 53 colleagues and contractors, including three team leaders (with teams of 8 to 21), professionals, OTE colleagues, and contractors supporting process validation, cleaning validation.
• Develops colleagues to help them reach their growth goals through strategic project assignments and cross-team developmental opportunities
• Works closely with customers to maintain communications and align priorities
• Supports manufacturing investigations, quality risk assessments, and strategic compliance implementations
• Manages customer audits

New York, New York, US

• Led a team of 11 professionals and one OTE colleague as QO Single Point of Contacts in implementing technical projects across the facility, including: - Site-to-site transfers of existing products, - New products under.
• The team's scope included the following areas of emphasis: - Raw material and packaging material evaluations - Analytical coordination - Site systems set-up and use (e.g., LIMS, QTS, SAP) - Manufacturing preparations.
• Built the team’s ownership culture, including helping the team develop our team charter, and support projects within our mission and purpose
• Developed colleagues to help them reach their growth goals through strategic project assignments and cross-team developmental opportunities
• Worked closely with customers to maintain communications and align priorities
• Supported deviation investigations, quality risk assessments and strategic product development

New York, New York, US

• As a developmental assignment, co-led a team of 9 professionals in implementing technical projects across the facility in API manufacturing (chemical, fermentation and bioconversion), sterile injectable (solution.
• The team wa accountable for on-time delivery of the projects through the leadership of cross-functional teams who have responsibilities that include the following: - Raw material and packaging material supplier.
• Leding improvements to the site's project management and coordination system through limited duration focus teams
• Developed colleagues to help them reach their growth goals through strategic project assignments and cross-team developmental opportunities
• Worked closely with customers to maintain communications and align priorities
• Budget planning, preparations, and management

New York, New York, US

• Identified developmental needs at both the Ethiopia and Atlanta ITI offices and coordinated a successful strategy to fill those gaps
• Trained the Ethiopia Country Representative on new leadership skills
• Facilitated improved communications between the ITI offices
• Coordinated development of supply chain/warehousing training
• Helped prepare the Ethiopia office for the 1st Annual Ethiopian Forecasting Meeting

New York, New York, US

• Coordinated PGS-Kalamazoo co-development teams tasked with finalizing and implementing new API and DP processes into Kalamazoo
• Led cross-functional teams transferring API and DP processes into Kalamazoo: - Identified and resolved systems limitations impacting the teams - Coordinated quality strategy for projects (e.g., during co-development).
• Supported international process transfers

New York, New York, US

• Coordinated the efficient use of limited resources in CI, QO/QC, and production areas to support customer needs by using consensus and open communication
• Actively participated in developing plans to address global manufacturing issues, including involvement in FDA audits and responses
• Led up to six supply teams, which encompassed professionals from twelve production areas, Supply Chain, Procurement, QO/QC, and Finance, to ensure the smooth production and supply of intermediates and APIs

New York, New York, US

• Coordinated more than ten simultaneous capital projects, totaling over $20MM, as the Customer Engineering Manager
• Developed and maintained long-range plans for capital upgrades and capacity expansion options for the area
• Hired and coordinated the activities of two summer interns, mentored six new production engineers
• Successfully prepared the area for a PAI which resulted in no FDA 483 observations for the production area

Abbott Park, Illinois, US

• Supported the manufacturing of a large volume API across three production facilities
• Implemented process improvements and developed optimization strategies for the API process
• Transferred the 2nd generation API process to two international facilities