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, training, and cGMP compliance. As a senior leader:• 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 development (codevelopment with R&D to produce clinical, registration stability, and commercial launch supplies), - 2nd generation API manufacturing processes, and - New ANDA products• 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 and support - Regulatory strategy development and documentation - Process validation - Product release• 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• Hosted regulatory and customer audits

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, suspension, and lyophilization), and non-sterile (solutions, ointments, creams, and lotions), including: - Site-to-site transfers of existing products, - New products under development (codevelopment with R&D to produce clinical, registration stability, and commercial launch supplies), - 2nd generation API manufacturing processes, and - New ANDA products• 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 qualification and procurement - Analytical method development, transfer and/or validation - Site systems set-up and use (e.g., LIMS, QTS, SAP) - Manufacturing documentation, scheduling, and support - Regulatory strategy development, documentation and submission - Process validation - Product release - Supply planning and coordination, including warehousing and distribution logistics• 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) - Facilitated timely resolution of implementation conflicts• 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