Edwin Cross Email & Phone Number

Hightstown, Nj, Us

East Windsor, New Jersey, United States

• Direct manufacturing functions to include planning, scheduling, batch processing, packaging and reconciliation; Resolve production related deviations and investigations• Oversee supply chain of raw materials, products and services; Ensure that raw materials are inventoried, tested and dispensed to production according to procedures • Maintain facilities, premises and equipment in good state of repair; Implement preventive / corrective maintenance programs and calibration programs• Ensure consistency and compliance with all external regulatory agencies to include FDA, EPA, NJDEP, DEA and OSHA; Liaise with local government and compliance agencies; Lead agency inspections and audits• Direct building security and EHS (Environmental, Health and Safety) functions across all facilities; Develop procedures and policies to sustain compliance• Develop short/long term strategies, goals, and objectives to ensure efficient manufacturing operations and site deliverables• Develop and maintain cross functional collaboration with Validation, Quality Assurance, and Regulatory Affairs groups to plan and implement the execution of cGMP activities in manufacturing operations • Prepare equipment and facilities and procure materials for launch of new products; prepare and lead PAI's• Develop and maintain training curricula for staff• Champion innovation and continuous improvement and contribute to the business results through quality of decisions, results and advice• Develop and implement metrics to track and lead successful, timely accomplishment of assigned goals and objectives• Manage facility construction and renovation projects within budget and project timelines. Procure, install and qualify equipment utilities

Northvale, Nj

Design facilities; Manage Construction and renovation activitiesDevelop and implement Standard Operating Procedures and PoliciesDevelop and maintain capital and Operating budgetOperate plant and critical utilitiesDevelop and implement EHS (Environmental, Health and Safety) programs and policies Operate facility in compliance with Federal (OSHA, DEA, EPA), State (NJDEP, DOH), and local regulations; Develop and implement policies and procedures, Train employeesManage Capital Projects

Summit, Nj

Direct Technology Transfer projects from discovery to commercialization Progress the pipeline by ensuring that projects are on track for NDA / MAA / MOW filingPlan and maintain integrated project plans across all work streams (DP, DS, CMC, Analytical Methods, and Facilities & Supply Chain) to meet submission requirements and launch datesChampion the CMC (Chemistry, Manufacturing, and Controls) work stream, representing a full view of each project to all stakeholdersManage projects involving third party manufacturesCommunicate critical project issues to senior stakeholders and seek resolution

Kenilworth, Nj

Directed a team of professionals consisting of Senior Project Engineers, Utilities Engineers, Controls Engineers, Mechanical Supervisors, and Safety, Health & Environmental specialists responsible for timely completion of consent decree commitments and activities outlined below: Managed construction, renovation and equipment upgrade projectsMaintained process equipment and critical utilities in accordance with cGMP requirements; developed and implemented preventive, and corrective maintenance procedures Directed the purchase, installation, and qualification of process equipment; performed FAT’sManaged deviation investigations; conducted FMEA’s for process equipment and critical utilities; implemented Corrective and Preventative Actions (CAPA)Prepared facilities and equipment for launch of new products; participated in pre-PAI auditsImplemented standard operating procedures for set up, operation, maintenance, calibration, and qualification of process equipment and critical utilitiesOperated and maintained pollution abatement equipment in compliance with applicable EPA, and NJDEP regulations; developed, implemented, and trained colleagues on related programs and policiesDeveloped and implemented programs and policies to comply with OSHA regulations to include Confined Space Entry, Lock-out/Tag-out, Respiratory Protection, and Hearing Conservation Developed and maintained capital and operating budgets for the Operations groupDeveloped and implemented training curricula for staff members

Northvale, Nj

Managed multiple functions to include Engineering, Manufacturing, Production Planning, Packaging and Materials ManagementManaged plant engineering and maintenance activities including EHS (Environmental, Health, and Safety) compliance responsibilitiesManaged production and packaging activities

Northvale, Nj

Directed plant management functions to include engineering, maintenance, security, project management, housekeeping and safety & environmental affairs for a pharmaceutical development, manufacturing, packaging, and distribution site consisting of four buildings (approximately 200,000 square feet) yielding up to 1.1 billion solid dosage units per year. Accomplishments included timely completion of consent decree commitments and zero observations on several FDA, EPA, DEA, and DOH inspections. Operated and maintained Manufacturing/Pilot Plant/Packaging/R&D equipment and critical utilities (USP water, HVAC, compressed air, steam, and dust collection systems). Managed all equipment qualification projectsInstituted computerized maintenance and calibration programs for over 1000 equipment and systems Developed, justified, and maintained operating and capital budgets for the siteDesigned and supervised construction and commissioning of offices, laboratories, packaging, R&D, and manufacturing suites; managed facility qualification projectsPrepared equipment and facilities for several new product launches; managed pilot plant activities; prepared for and completed several successful PAI’sProvided technical support to Product Development, Manufacturing, Packaging, and Validation departments; supported process validation and cleaning validation projectsRepresented company during visits to the FDA district officeMaintained compliance with air, soil, storm water and waste water discharge permits; purchased and installed several pollution abatement and monitoring systems including catalytic oxidizers and continuous emission monitoring systems (CEMS); prepared monthly and annual reports to comply with EPA, NJDEP, RCRA, and RTK regulationsManaged hazardous waste for a large quantity generator (LQG). Formulated contingency and emergency response plansDeveloped and implemented several safety and health programs

Tamil Nadu, India

Taught engineering courses to undergraduate engineering students,

Master'S Degree, Engineering

Master’S Degree, Mechanical Engineering

Activities and Societies: ASME ISPE

Master’S Degree, Personnel Administration And Industrial Relations

Activities and Societies: University President's Academic Excellence AwardKnowledge of Labor Laws, Collective Bargaining Agreements.

Bachelor’S Degree, Mechanical Engineering