David Conapitski

This was a new function added to Analytical Development (AD) in 2017. Built a team responsible for providing operations support to a large analytical development organization. The team is responsible for Sample Management, Documentation Management, Global Change Control Facilitation and Instrumentation Support related to calibration and validation of existing instrumentation, as well as the on-boarding of new assets and decommissioning of assets.

The team supports a large AD organization across several buildings and campuses.

• Built and strengthened relationships with vendor representatives in order to maintain consistent supplies.
• Analyzed life cycles, equipment, processes and effectiveness of different manufacturing strategies.
• Developed and deepened relationships with vendors to meet or exceed supply chain production standards.
• Trained and developed department staff for specific projects and ongoing operational needs. This includes talent development and personal development
• Lead continuous improvement activities

Managed Centralized High Throughput GMP Lab and Non-CMP labs responsible for providing analytical support for process characterization, process validation and other testing support not supported by QC or Clinical Release and Stability (CRS) Group. Customers include, API (Process characterization and validation testing), DPD (Process characterization and validation testing), CRS, (Life Cycle Mgt) and (Method optimization, co-validation support and late phase development testing).

• Lead teams of up to 18 personnel, supervising daily performance as well as training and improvement plans.
• Trained and developed department leaders and management staff for specific projects and ongoing operational needs.
• Assisted senior leadership in managing all aspects of operations.
• Networked with local and regional businesses to promote partnerships and drive cycle time improvements.

This was a one year rotational opportunity outside my existing organization leading to personal development nd building connections. Managed start-up activities related to instrument qualification and training for GMP Lab supporting API, LMMD, CRS and DPD. Provide compliance support for department related to training, audits and non-conformance tracking. Evaluate compliance systems and provide direction to implement process improvements.

• Assisted senior leadership in managing all aspects of operations.
• Lead teams of up to 5 personnel, supervising daily performance as well as training and improvement plans.
• Networked with local and regional businesses to promote partnerships and drive growth.

This was a one year rotational opportunity outside my existing organization leading to personal development and building connections. My role was as an individual contributor supporting global R&D QA.

I provided external service provider support related to clinical audits. Liaison to Quintiles; provided quarterly metrics related to Quintiles compliance profile. Managed "Risk Tool". Risk Tool helped to define audit candidates and prioritize audits based on past compliance concerns and future use of a vendor. Provided support compiling, summarizing and creating PowerPoint presentations for QA Stage Gate activities.

Responsible for oversight of scientific organization charged with the release and stability of phase I/II clinical supplies in addition to nonclinical toxicology GLP studies.

• Lead teams of up to 30, personnel, supervising daily performance as well as training and improvement plans.
• Trained and developed department leaders and management staff for specific projects and ongoing operational needs.
• Assisted senior leadership in managing all aspects of operations.
• Oversaw the transition of the organization from Spring House, PA, to Cork, Ireland. This included transfer of methods, instrumentation and assisting with the hiring of Cork Management and up to 20 staff members.

Manage the following functional groups within a commercial QC Organization: QC Investigations, Technical Support, Laboratory Support, Biochemistry and Cell Culture release and stability testing for Remicade.

QC Lead for regulatory inspections

• Managed large-scale projects and introduced new systems, tools, and processes to achieve challenging objectives.
• Determined priorities and set policies.
• Supervised and directed Managers to keep projects on-track and tasks prioritized.

During my 15 years of service I held various roles of increasing responsibility:

Senior Microbiologist - Performing R&D and Commercial Testing.

Section Head - Supervised lab staff performing CFR/USP release and stability testing, assay development and cleaning validation assays supporting manufacturing activities. Responsible successful PAI for method development and qualification.

Associate Director - Responsible as site head for all aspects of all quality systems for manufacture, fill and testing of clinical material. This included API manufacturing through final filled material for biological products. I had the opportunity to build a full service QA Team of 17 professionals responsible for day to day activities and final product release, as well as consent decree remediation.

• Trained and developed department leaders and management staff for specific projects and ongoing operational needs.
• Assisted senior leadership in managing all aspects of operations.
• Analyzed impacts of regulatory changes on operations and developed mitigation plans.

This was my first position out of college. This was a small biotech organization. I had the chance to wear many hats from leading training activities, hosting customer visits and managing billing activities. The groups focus was preparing Custom Reagents for other Pharma Companies.

• Applied strong leadership talents and problem-solving skills to maintain team efficiency and organize workflows.
• Handled customer complaints, resolved issues and adjusted policies to meet changing needs.
• Evaluated employee performance and coached and trained to improve weak areas.
• Maintained compliance with company policies, objectives and communication goals.