Doug Mcleod Email and Phone Number

- Provides strategic leadership for internal Kilo Lab production and supply of small molecule drug substance for clinical development of new pharmaceutical products.- Accountable for GMP Antibody Drug Conjugate facility and strategy to ensure clinical supply of drug substance is made.- Accountable for oversight of compliance activities supporting quality and regulatory requirements for internal and external supplies for the CPD department

• Responsible for managing complex internal and external interfaces on the implementation and execution of processes within the global API manufacturing. Responsible for ensuring that the safety and quality portfolio delivery goals are met by providing expertise in the scale-up of processes.• Partners with the API Operations Leadership Team and other key stakeholders in Operations and Product Development to enable the successful delivery of the portfolio from the global manufacturing network through the use of deployed technology. • Partners with Strategic Partner Management and Chemical & Synthetic Development (CSD) to assess process capability as a key input to the supply strategy and campaign placement within the global partner network. Drives a portfolio perspective across individual assets to ensure performance metrics are achieved. • Supports the Innovation & Network Strategy Lead in network capability analysis and network risk assessment.• Provides technical leadership and expertise in the scale up of processes. May act as primary technical support or ‘first responder’ for campaigns with minimal engagement of development scientists and/or knowledge generation or value. • In addition to leading process specialist group held interim responsibility for leading additional groups while new leaders were identified. • Accountable for a high level of team leadership and the development of team members in different geographies.• Lead Tech Transfer activities to internal and external manufacturing partners

Develop strategy to ensure scheduling, operations, process introduction, capital improvements, and maintenance run flawlessly for multiple pilot plants.- Member of the API-Operations Senior Leadership Team - Strategically ensure team of 20+ employee’s is trained and proficient in needed areas and developed to meet future challenges. - Standardized unit operations via control system operations across BMS pilot plants.- Accountable to ensure pilot plant cleaning protocols are compliant with internal procedures.- Lead numerous interface teams to ensure cooperation and effective communication between departments.- Initiate, review, and approve capital projects within area of responsibility.- Qualified batch record reviewer and quality investigator.- Review and approve both Process and Equipment/System Change Controls- Review, approve, and author procedural documents

Responsibilities: The Chemical Process Engineer manages the overall technology transfer of processes into the Chemical Development Operations (CDO) scale up facilities and serves as primary CDO interface for key stakeholders and customers for assigned projects. Responsible for all CDO deliverables associated with the process execution. The key responsibilities and major duties for the process engineering position are:- Perform process engineering analysis to determine cycle time, equipment fit, technologies required, scale up risk, etc.  - Recommend laboratory experiments to inform scale up plans.  - Translate engineering process flow diagram/scientific description into process recipe for deployment. - Provide process engineering expertise to the Hazard Evaluation Lab and the Process Hazard Analysis team to identify requirements for non-standard engineering controls within process implementation.- Provide process engineering expertise within plant introduction workflows - Provide technical expertise for infrastructure support and capital improvements, and design of new equipment and operational capabilities  - Provides process engineering expertise to technology transfer of projects to internal and external manufacturing locations. - Serves as subject matter expert for recipe construction. Maintains standard recipe components within the process automation system. Provide process expertise in batch record review in conjunction with building management and the process manager - Perform engineering analysis of process execution, recommends opportunities for improvement with plant efficiency and risk mitigation as goals, and captures analysis in summary documents  - Act as a quality events investigator for assigned projects.

- Chemistry lead on IGF-1R project; oversaw research activities of three colleagues.- Led HPLC column reuse initiative which saved $120,000 over its first year of operation.- Participated in multi-disciplinary teams: o LPA-1 and IGF-1R Integrated Development Teams which ensured alignment within the CMC functions and supported the organizations material needs.o LPA-1 and IGF-1R Material Selection Development Teams which coordinate drug substance powder properties among key stake holders.- Developed chemical process and wrote technical transfer documents for synthetic steps run at vendors - Collaborated with suppliers to ensure proper data collection and timely delivery of high quality advanced intermediates- Developed multiple API steps that were run on 100+ Kg scale- Conducted independent research to design and develop multi-step chemical process in an environmentally friendly, safe manner that were capable of being scaled to manufacturing scale.- As a member of a pilot plant start-up team took part in IQ/OQ/PQ activities and wrote work instructions for plant equipment

Design of multi-step synthesis and scale-up of safe and environmentally friendly pharmaceutical processes from laboratory scale to pilot plant- Successful implementation of chemical processes in the pilot plant on multi-kilogram scale- Experience with the preparation of API under cGMP (current good manufacturing practices) requirements