Management
Project Management
Throughout my career, I have contributed to a variety of projects that span different scales and complexities. Early in my career at Genentech, I collaborated as a team member on initiatives to introduce new equipment and processes. I have also been involved in tech transfers—ranging from international transfers to scaling processes from the bench to GMP manufacturing floors—and participated in teams responsible for establishing new GMP manufacturing capabilities.
In addition, I have led dozens of Kaizens, treating each as a focused project with clearly defined goals, deadlines, and report-outs. Most recently, I took on a technical leadership role in converting a pilot plant into a facility for GMP clinical material production, requiring a blend of engineering expertise and administrative problem-solving.
One of the largest projects I supported was the consolidation and launch of a new manufacturing building. I joined this multiyear project as the Process Engineer Lead towards its final stages, stepping in for the previous engineer who went on leave. At the time, the project was two months from its deadline, and I was informed that completing it on time was deemed impossible. By engaging stakeholders and implementing increased reporting frequencies to quickly address roadblocks, I facilitated the successful, on-time completion of the project.
People Management
I have managed teams ranging from small groups of three to multi-shift departments with over 20 members. Additionally, I have often engaged in indirect management within project teams, frequently "managing up" to align goals and priorities across different levels of an organization.
Over my career, I’ve observed that technical experts are often promoted into management roles due to their subject-matter expertise. While this can lead to effective decision-making, it often comes with a gap in formal training in people management. Through my MBA coursework, I gained valuable insights into emotional intelligence (EQ) and various management methodologies, which have helped me bridge this gap.
The management style that resonates most with me is Situational Leadership, also known as Conditional Management. This approach closely aligns with my natural management tendencies, but formal training allowed me to refine my style further. Situational Leadership emphasizes adapting one's approach based on the specific needs of the task, team, or individual, recognizing that no single management style is universally effective. By being flexible and responsive, I’ve found this method to be highly effective in fostering team engagement and achieving desired outcomes.
Process Management
I have managed diverse processes, including drug substance manufacturing, oversight of Contract Manufacturing Organizations (CMOs), and internal quality processes. While each presents unique challenges, they share commonalities in management oversight. At a high level, identifying unexpected results, recurring issues, and critical events in various inputs is crucial for swift mitigation and maintaining operational efficiency.
A key tool I leverage is Value Stream Mapping, which aids in visualizing and analyzing workflows. This method helps pinpoint deviations, long wait times, bottlenecks, and other inefficiencies (or MUDA) in processes, enabling targeted improvement efforts. It is instrumental in mistake-proofing and streamlining manufacturing operations.
Another strategy I employ is Total Productive Maintenance (TPM), which focuses on enhancing the effectiveness of production equipment by involving all organizational levels in maintenance. The goal of TPM is to eliminate breakdowns, defects, and accidents that disrupt production, fostering a culture of proactive equipment care and operational excellence.
In the realm of CMO management, I have provided technical oversight by reviewing and approving executed batch records and serving as a Person-in-Plant (PIP) to observe and support operations directly. Acting as a PIP requires both technical acumen and diplomacy to ensure seamless collaboration between contractor and client. Additionally, I have served as the CMO provider and primary point of contact for upstream operations, ensuring alignment and successful execution of manufacturing objectives
