Name:
Howard Jan
Country:
USA
City:
San Diego
State/Province:
CA
ACS Member:
Non-member
Local Section:
L626,San Diego
International Chapter:
Technical Division Membership:
Technical Division Membership Emeritus:
Subdivision Member:
ACS Activities:
Company/Institution Name:
Genentech
Career Stage:
Professional
Research and Special Interests:
https://www.linkedin.com/in/howard-jan/
I am a project manager and scientific leader with comprehensive CMC project experience from pre-clinical through Phase I / II / III and BLA filing in the pharmaceutical industry. As a protein chemist by training with extensive experience in drug development with a focus on product development, I am a PMI certified project manager with strong leadership and communication skills for leading cross-functional in the development of commercial drug candidate.
•13+ years of industry experience yielding a broad knowledge of phase-specific, global CMC practices and regulatory requirements gained through full project experience advancing protein therapeutics.
•Extensive expertise in protein physicochemical and functional characterization, formulation / analytical method / process development, PEG conjugation, process transfer to CMO (GMP), and method transfer to CRO.
•Managed alliance and CMO / CRO partnerships for phase-specific CMC strategies, internal and external co-formulation development, analytical method development, technical transfer and support for drug substance and drug product manufacturing.
•Facile with Quality by Design (QbD) and JMP for statistical data analysis, specification setting, process control, method monitoring, comparability, and Design of Experiments (DoE).
•I led the team to meet aggressive timelines by adjusting budget, resource, scope, and schedule with a focus on risk analysis and critical path. (Collaboration and Integration)
LEADERSHIP COMPETENCIES
Leadership / Influences
•Lead a cross-functional and multicultural team to achieve project goals in aggressive timelines.
•Influence CMC team for implementing major changes (QbD) without formal authority.
•Identify risks with critical thinking ability and proactively plan risk responses.
Communications
•Openly and rapidly address conflict and collaboratively identify constructive solutions.
•Encourage healthy discussions and give / receive constructive feedback.
•Manage culture differences with clear communication and convert them to productivity.
Passion for Growth
•Strong desire to learn allows me to incorporate new technologies and knowledge to the team.
•Exercise creativity to ensure the success of results delivery.
•Willingness to admit mistakes and stay humble for continuous growth.
Team Development
•Offer help to team members to build trust. Reach out for help when needed.
•Appreciate social diversity for its contribution to a wider view of the scientific enterprise.
•Mentor and practice with team members for the importance of risk assessment.
Email: hjan2000@yahoo.com
Area of Expertise:
CMC Project Manager, Technical Development at Genentech | Project Management | Pharmaceutical Drug Product Development | Scientific Leader in CMC from IND through Phase I / II / III and BLA, PMP
Years of Expertise:
16-20