Daniel Bink Email & Phone Number

Carmel, New York

Carmel, New York

Ramsey, Newjersey

• Direct client interface during the development, scale-up, transfer and commercialization of products.• Documentation including Protocols, Batch Records, Process/Product Development Reports and Validation Documents.• Identification of critical scale-up and process validation parameters for each project in close association with Technical Process Operations and Commercial Manufacturing.• Coordinate with Business Development, Planning, Quality Assurance, Contract Manufacturing and Development on behave of external client projects.• Technical and Process training of Manufacturing personnel as part of product transfer or new product introductions.• Provide guidance and mentoring to junior scientists and technicians.• Serve as process technology expert for new product operations with scientific, mechanical and systems knowledge.• Experienced in processing and reconciliation of controlled drug substances (schedule 2-5).

Perform In process suite inspections, as well as equipment inspections prior to manufacturing start-up.Prepare, review and issue batch records and labels for Contract Manufacturing.Create/Author all product batch records for bottling line packaging operations.QA Lead for packaging operations.Responsible for QA review and monitoring of all Preventive Maintenance and Calibration Documents.Participate in FDA and Customer quality audits.Author Customer Complaint Responses, as well as Deviation Reports and CAPA’s.Perform in-house calibration/verification of scales, balances’ moisture analyzers and hardness testers.Track USP Purified Water test results and approve USP Purified Water C of A’s.Perform raw material sampling, in process sampling as well as scheduled stability sampling.Maintenance and monitoring of USP Water purification systems.Off site contractor / third party process and systems auditing.Adherence to SOPs and cGMPs.

Functioned successfully in a controlled clean room environment for many different products such as Diovan, Tegretol, Coartem and Ritalin, accountable for accurate electronic batch records and following SOPs / TTOs in a cGMP environment.2nd shift Controlled Drug vault attendant.Performed all duties on the second shift, and worked completely independently for six years.Responsible for label generation, inventory control of pharmaceutical bottle labels in secure area.Initiated and completed reconciliation investigations to resolve any discrepancies that occurred.Created production schedules, prepared packaging orders and reconciled all printed components, drug products and completed all required critical paperwork.Cross-trained successfully in operating compression and coating machines, transdermal ointment preparation, product sampling, QA, and line clearance / cleaning for product changeovers.Trained others in SAP utilization system and was recognized and designated as a "Super User".Volunteered to be an active member of Novartis Emergency Response and Hazmat teams.Overall personal performance was continuously rated "above average", and received countless peer and management awards for excellent accomplishments and daily work outcomes.Recognized as key contributor to upgrading from paper to electronic batch record systems.Promoted to packaging / labeling room after excellent performance in the transdermal operation and in general production area.Trained for hazardous materials handling to the level of Technician as well as a fork lift operator.