Jack Sinclair Email & Phone Number

Hatfield, Pa, Us

Cambridge, Ma, Us

Head of Compliance for the Hopewell NJ facility

Somerset, Nj, Us

Quality Organization and Site Leader for Philidelphia manufacturing facility.

Sr. Director – Quality Assurance & Quality ControlSite Quality Lead for sterile injectables and pharmaceutical topical, cosmetic, and over the counter (OTC) products (Buena, NJ). • Quality Assurance/Quality Control Director of a cGMP facility leading a team of ~ 40 quality employees in all aspects of Quality Control and Quality Assurance. • Site Champion responsible for ensuring continuous inspection readiness.• Mentor, coach, and lead to ensure direct reports possess the knowledge and expertise to perform the job duties. • Direct a Quality Control Laboratory for raw material, finished goods, and stability testing on topical and sterile injectable products. • Direct Quality Assurance Department of engineers for routine product release, investigations, customer complaints, corrective and preventative actions, changes, and all other site quality infrastructure systems (e.g. shop floor support, batch record review, pest control, process water). • Site Responsible Individual to manage all external customer and regulatory audits and inspections. Directly responsible for Warning Letter remediation activities.

Radnor Township, Pennsylvania, Us

Quality Manager – Avantor Performance Materials (Legacy JT Baker), Phillipsburg, NJ & Bethlehem, PA Site Quality Lead for bulk chemical, excipients, and APIs manufactured at two manufacturing plants (Phillipsburg, NJ & Bethlehem, PA). • Site Quality Lead and Quality Departmental Manager, of two Good Manufacturing Practices (cGMP) facilities leading a team of 35 quality employees (union and non-union) in all aspects of Quality Control and Quality Assurance. Supplying an international customer base of the pharmaceutical, electronic, and food industries with legacy JT Baker chemicals. • Site Champion responsible for ensuring continuous inspection readiness.• Site Champion responsible for all Quality decisions on two manufacturing sites.• Mentor, coach, and lead to ensure direct reports possess the knowledge and expertise to perform the job duties. • Direct a 24/7/365 Quality Control Laboratory for raw material, in-process, and finished goods testing on bulk chemical salts, solvents, acids, bases, solutions, reagents, sugars, and resins to support routine manufacturing operations. • Direct a two shift Quality Assurance Department of engineers for routine product release, investigations, customer complaints, corrective and preventative actions, metrology, stability, changes, and all other site quality infrastructure systems (e.g. shop floor support, batch record review, pest control, process water). • Directs Quality Assurance support for Pilot Plant Operations for new product development, validation, manufacture, and release.• Site Responsible Individual to manage all external customer and regulatory audits and inspections (~ 30 a year including FDA, ISO 9001 and ISO 22000 Food Safety System Certification).• Manage departmental budgets (realized ~ $400K savings in 2018 with shift modification and overtime reduction).

Rahway, New Jersey, Us

Site Technology Lead for raw materials, excipients, primary packaging, and single use components (incoming materials) utilized in all vaccine manufacturing operations at West Point. • People Manager leading a team of eight employees on end-to-end project management which includes supply chain management, new material qualification, analytical testing determination, and all quality and release attributes. Projects focus mainly on new raw materials/excipients, new vial and syringe images, and new single use component designs. • Review and approve yearly objectives/accomplishments, employee development plans, perform mid-year/year end performance reviews, complete departmental rankings (based on performance), author position descriptions, interview candidates, determine and communicate work/project assignments.• Ensure direct reports possess the knowledge and expertise to perform the job duties. • Currently manage vendor change notifications from external suppliers (~ 150 per year). • Currently manage all incoming material investigations for West Point, PA (~ 200 per year). Work extensively with external suppliers and manufacturers and internal customers to determine root cause, product impact, and product disposition. Design corrective and preventative actions (both internally and externally) to reduce investigational cycle times, significantly reduce production down times, and reduce product discards. • Subject matter expert representing incoming materials for all internal and external inspections.• Establish all qualification and analytical requirements for commodity or custom raw materials (cell culture media and buffers). Extensive work with external suppliers, manufacturers, and contract manufacture organizations (CMO) throughout the qualification process.

Rahway, New Jersey, Us

Provide technical, analytical, and quality support for Merck’s worldwide portfolio of vaccine products for all single use components, raw materials and excipients utilized for manufacture on a global level.• Provided global expertise for raw material and excipient technical support for all Merck vaccine and biologic manufacturing sites. End-to-end project management which includes supply chain management, new raw material qualification, analytical testing determination, and all quality and release attributes. • Technical supervisor responsible for leading vendor change management for raw material suppliers on a global level. Led a team of eight employees for assigning, reviewing, and technically approving approximately 100 changes annually.• Managed all raw material manufacturing and single use component investigations for West Point, PA. Work extensively with external suppliers and manufacturers and internal customers to determine root cause, product impact, and product disposition.

Rahway, New Jersey, Us

Provide technical, analytical, and quality support for Merck’s portfolio of recombinant vaccine products. • Supported GARDASIL®, RECOMBIVAX HB®, and alum manufacture by providing on the shop floor technical support for purification.• Performed RECOMBIVAX HB® manufacturing investigations, assessed root cause, product impact, and assigned corrective actions. • Provided first responder floor support to immediately address issues.• Managed RECOMBIVAX HB® change control products for purification production process improvements and validation projects.• Performed appropriate laboratory experiments to create lab-scale GARDASIL® intermediates samples for comparability studies.

Rahway, New Jersey, Us

Developed the technical support infrastructure for releasing raw materials, culture media, internally manufactured buffers, and excipients utilized in the manufacture of GMP vaccine and biological clinical supplies. Significant responsibility for managing scientific, quality, and regulatory policies while creating new business systems.•Supported up to 10 annual clinical campaigns of seed, cell banking, and safety assessment through phase III clinical bulk, final formulation and filling.•Authored technical evaluations to determine bovine spongiform encephalopathy and transmissible spongiform encephalopathy (BSE/TSE) risk assessment for animal derived raw materials per domestic (21CFR9) and international (EMEA/410/01) regulations.•Manage all raw material research investigations for West Point, PA site. Determine root cause, product impact, and product disposition.•Since 2001, Merck Research Labs subject matter expert for vaccine and biological raw materials. Represented raw material systems during domestic and international audits.•Reduced cycle time by two months, by designing systems based on Six-Sigma methodologies to release internally manufactured buffers with in-line analytical measurements. This eliminated sample submittal procedures, reduced release testing requirements and costs ~ $250K annually.

Rahway, New Jersey, Us

Developed all internal procedures to plan, procure, submit, test, and release all raw materials, culture media, internally manufactured buffers, and excipients used to manufacture GMP vaccine and biological clinical supplies. Significant responsibility for people management while establishing scientific, quality, and regulatory policies based on domestic (USP, 21CFR210 & 211) and international (EMEA, PhEur, and JP) guidelines.•Managed five regular full-time employees that supported raw materials and internally manufactured buffer release systems. Managed the areas of raw material request, raw material procurement, raw material movement, scheduling internal buffer manufacture, analytical method development, release plan authoring, sample submittal, and data review (utilizing SQL*LIMS, SAP, ERP, and TrackWise).•Reviewed and approved yearly objectives/accomplishments, employee development plans, performing mid-year/year end performance reviews, completing departmental rankings (based on performance), authoring position descriptions, interviewing candidates, determining and communicating work/project assignments.•Ensuring direct reports possessed the knowledge and expertise to perform the job duties. •Developed and executed a comprehensive system for risk assessment. Defined risk parameters and communication tools to ensure product and facility quality.•Developed, executed and managed the infrastructure to create buffer batch documents.•Developed release and characterization assays, analytical specifications, material expiry, storage conditions and container closure requirements as quality attributes.

Rahway, New Jersey, Us

Project Manager for all EPA projects from conception to conclusion. Established a client base of approximately 75 people from Merck sites along the east coast and Puerto Rico.•Projects included all potable, wastewater, and soil analysis by SW846, and CLP methodologies.•Supported product release by managing metals testing for raw materials. Start up of second shift laboratory operations. Maintained GLP criteria for organic, inorganic, and wet chemical testing labs.•Developed, implemented, and managed all second shift work flows, quality, and business systems. Managed 10 hourly technicians and clerks, who were part of the labor bargaining unit.•Responsible for daily production scheduling; tested approximately 2,000 samples annually.•Managed all internal and external (EPA, FDA, EU, NRC, PADEP) quality audits