“I had the privilege of helping the ISPE Boston Chapter organize their first half-day conference. This was my first time working behind-the-scenes, but I shouldn't have been surprised by the amount of work required to bring a conference such as this from concept to reality.
The Educational Programs Committee worked from the beginning of the year to identify the topic, date, location, and speakers. As a team, we decided that Project Management would be the overall focus, given the huge number of capital projects underway in the Boston life sciences space. We also decided to hone in on the culture of project management, meaning what we could do to ensure we build the right culture within our projects to ensure success.
My small role in all of this was to work with one of our speakers on finalizing a topic for the session, develop the content together, and manage the logistics for the session. Steve Marr, Takeda's Head of Capital, was my assigned speaker within the track of "Tools and Techniques for Effective Project Management." Steve proposed a talk centering on Shire/Takeda's 2018 Facility of the Year Award winner, Los Angeles Building 8. The story behind Building 8 was fascinating, featuring various design challenges, such as integration into an existing operational site without interruption of services, siting the new building less than 6 inches from an existing adjacent building, and relocating half-century-old utility services with layout diagrams just as old as the utilities themselves!
In the end, Takeda's LA Building 8 was successful and represents an excellent model for new construction on an older site with sever footprint limitations — proven by the FOYA accolades.
The other conference sessions were quite interesting as well, with a riveting keynote from Pfizer's Gil Stevens and conference tracks focusing on Organizational Culture, Strategies and Tactics, and Tools and Techniques. I enjoyed being behind-the-scenes and helping out with the organizational duties, and am looking forward to next year's conference!”
- Aaron Hubbell, East Coast Regional Director at Delta PM
Why did you choose to pursue consulting?
After working in the industry for several years and being exposed to many different roles, validation seemed like the best fit. I also wanted the freedom that consulting allowed. Having the opportunity to broaden my skillset by working on a variety of projects at a variety of locations is a dream come true!
Why did you join Delta PM?
I had only heard good things about Delta regarding the culture, the opportunity for growth, and the awesome people from Deltoids I had met at previous positions. I also experienced it all firsthand throughout the interview process.
How has your experience with Delta been fulfilling or different?
The ability to expand my knowledge and skill set by working on so many different projects has been incredibly fulfilling. Even more so is the encouragement, guidance, and knowledge shared by the Delta PM team, which has empowered me to continue to grow and develop. Through Delta, I have also had numerous opportunities to attend industry events, where I’m constantly learning about new advancements or better ways of doing things. All of this ensures that my role never feels stale.
How would you characterize your team?
The Delta team is extremely supportive, so that even working on a solo project never feels isolating. I know I can always reach out to my coworkers with questions or for support. Plus, there are awesome company events where everyone is able to come together to catch up.
“ISPE SF Vendor night was a first for me. It was fascinating to finally meet some of my West Coast Delta colleagues and spend time with those whom I have not yet had the chance meet in-person. The event was full of passionate individuals, and I was really impressed with the turnout at Oracle Park. A group of Delta employees attended and I felt proud to be a part of such an amazing team of smart, talented, and driven people. I am looking forward to the future, as we continue to strengthen our culture and build relationships in emerging markets.”
- Eric Nelsen, East Coast Validation Manager at Delta PM
“Delta PM hosted a booth again for the Annual SF Bay Area Vendor Night at Oracle Park (formerly AT&T Park). This year’s theme was Monte Carlo, so we had a roulette game, blow-up dice, and a green card cloth for our table. Our booth was on a corner, so we gathered quite a crowd with new and old faces alike. Our team had a great time meeting and catching up with clients, old colleagues, and prospective candidates and partners for our business.
ISPE Vendor Night showcases amazing new products that are being used in the industry, but it’s also a way for everyone in the Bay Area (and non-locals who come out) to get together once a year and discuss what progress has been made at their labs and workplaces. These discussions focus on the diversity of personnel, lab expansions, new construction, and using the best form of intellect to find a cure in their prospective clinical trials.
Our team and some others we met at the event headed to Lucky Strike afterwards to enjoy everyone's company and continue our conversations over some bites, drinks, and bowling. It was a fun night and was great to see some old faces and hangout with the rest of the team!”
- Allison Shaw, Recruiter at Delta PM
Register now for the ISPE San Francisco Bay Area Chapter’s Women In Pharma Unite and Break The Glass Ceiling event hosted by Delta PM’s very own Executive Chairman, Feras Al-Zubaidy. This night of networking and panel discussion will be held at the Berkeley City Club on Wednesday, May 1, 2019 from 5-8pm! You can find more details here.
“No Boundaries on March 7th in Irvine, CA was an inspiring night and the first of its kind. Thao Nguyen, Chair of the Los Angeles ISPE chapter, set the tone for the night by sharing what “No Boundaries” meant to her as a woman in Engineering and Pharma. She then introduced Ariel Kramer, Chief Communications Officer of CELLINK, who served as the moderator for the discussion. The panelists for the evening included Angela Swanton, Site General Manager at TEVA Pharmaceuticals; Jessica Rousset, Chief Operating Officer at CURE Pharmaceutical Corporation; Linda Soo Hoo, PhD, Associate Director of Technical Services at Gilead Sciences; and Elizabeth (Liz) Orwin, PhD, Engineering Department Chair at Harvey Mudd College. As an attendee, I had the privilege of seeing an intimate glimpse of what No Boundaries meant to each of the panelists. Jessica advised attendees to view every task as an opportunity, to build a reputation with everything you do, and to always be bold and curious. Angela credited a deliberate development plan to have paved her road to her current state. Linda reminded us to be fearless and fear less, while also being less hard on ourselves. In summary, the consensus was to not let boundaries be imposed onto you, but instead create personal boundaries that facilitate your vision – a message that resonated with the room.”
- Nicole Haddad, Validation Project Manager at Delta PM
A few weeks ago, Delta PM hosted a booth at the PDA (Parenteral Drug Association) Annual Meeting in San Diego. We enjoyed many discussions with colleagues in the industry on topics, such as Quality Risk Management and Data Integrity. Thank you to the PDA and all those who stopped by — we look forward to seeing you again at future events!
“The 2019 ISPE Ski Trip in Waterville Valley was a wonderful experience. I was motivated to take advantage of the winter weather in New England (which can be difficult to overcome at times), and overall, it was a phenomenal way to kick off the month of March. Some of the many highlights included skiing with those I had never skied with prior, bonding with the East Coast Deltoids at Delta PM (Nicole Rivera, Nephtali Roman-Reyes, Kero Habib, and Aaron Hubbell), soaking in the sun at the summit, learning about the landscapes of the surrounding mountain ranges within view, and meeting many new industry faces in the lodge and on the "legendary" bus ride.
I learned very quickly that this event is much more than just a networking experience or an opportunity to bond with coworkers, it's an annual tradition for many folks and they make it a priority. I am very thankful to the ISPE for organizing this event and deeply appreciate the efforts of both the sponsors and organizers for their contributions year after year. It was exciting to see our Delta PM team had 5 members in attendance, and I think we scored a 10/10 as a unit for our attitudes and efforts on the hill. As the day unfolded, it became very clear to me that it doesn't matter what we are doing as a group, we always exceed each other's expectations.”
- Eric Nelsen, Northeast Regional Validation Manager at Delta PM
Why did you join Delta PM?
All of the people I met that worked at Delta PM were happy, motivated, and capable individuals. I knew that these were the people I wanted to have as coworkers, mentors, and friends. When Delta extended an offer, I jumped at the opportunity to become a part of the team.
how has your experience with Delta been Different or fulfilling?
Delta PM has been very supportive and encouraging of my career development goals. They actively engage with me in these conversations and proactively look for opportunities where I can learn and grow my career. Also, the team camaraderie and support for one another at Delta is truly special. Even though we may not always be on the same projects, I always feel comfortable approaching any Deltoid for advice and encouragement.
What does your role entail and why did you choose to pursue consulting?
I am currently involved with various projects as a Validation Engineer. In this client-facing role, I collaborate with subject matter experts and project managers to author, schedule, and execute validation-related documents, such as commissioning and qualification protocols. I enjoy consulting because I thrive on "high speed, low drag" kind of work. This type of project-based work also allows me to meet tons of talented and creative people.
What’s your favorite memory during your time at delta?
It's not particularly exciting, but there was a particularly rough patch of execution work that the team completed. That very same night we went out for dinner afterwards, and it may have been the best pizza I've had in a very long time.
Do you have any Consulting best practices, tips, or other career advice?
In general, I've found that doing the right thing, even though it may be hard, has resulted in many opportunities and lifelong friendships.
“ISPE CEO night is always an event to look forward to each year. I really enjoyed the primer on biotechnology's history that Bob Kiss, the VP of Sutro BioPharma, presented. It spanned from the 1920's (insulin, blood clotting factors), 1970's (recombinant DNA), 1980's (eColi and CHO cell lines), 1990's (increasing yields), 2000's (cell free production) to 2010's (synthetic biology). It's easy to forget how new this field really is. I was looking back at my time at Bayer (2005-2007), where we were developing the Pilot Manufacturing Suite for a new protein-free Kogenate (Factor VIII blood clotting) that was using some of these groundbreaking cell-free production techniques. Most folks outside of the industry have no idea how synthetic biology is going to change the industry in the next two decades. Gilead, via its new acquisition CDL, is on the cutting edge in the Bay Area: https://www.ucsf.edu/news/2018/06/410626/startup-science-how-wendell-lims-idea-synthetic-cells-took-silicon-valley-storm
I also enjoyed hearing Kathy Yi, CFO for Sangamo Therapeutics, speak about their new project in Brisbane. I was working at UltraGenyx during the beginning of this project and knew the PM from Dome Construction, who had just finished a project for us next door, so I had inside knowledge on the Sangamo project.
Finally, Allison Moore, VP at Allogene Therapeutics, was describing the new techniques of scaling up production of CMC small/large-scale drugs. The current method requires that the patient be healthy enough to generate the immune response required to harvest their own cells and purify them for reintroduction to the patient. The new technique from her company is to de-couple the patient from the process by harvesting the immune response from healthy patients, stripping out the specific elements that will cause a foreign immune response from the sick patient, and then scaling it up using CMC so that multiple patients can receive the treatment. This reduces costs tremendously and allows for the drugs to be available immediately, not weeks later as with the personal medicine techniques currently being used.”
— David O’Connell, Project Manager at Delta PM
“CEO Night is always a great event, and I enjoyed all three speakers at this year’s event.
Bob Kiss presented on Synthetic Biology, a process of extracting kinases from cells. This process is new to me, but companies like CDL and Sutro have been working on this technique for years. CDL is actually one of my active clients, and I am currently expanding their BSL2 labs for this very purpose. This company is now expanding rapidly under the guidance of Kite Pharma and their mother company Gilead.
Allison Moore, as David mentioned above, shared her insights on how to scale up manufacturing processes to accommodate growth for small-scale processing, a method using CMC. She went on to talk about gene therapy and introduce us to a new method of processing T-cells. This technique takes cells from healthy patients, engineers the cells, and makes them available to all patients in times of need. This new process is much quicker than the traditional way of processing cells — resulting in potentially higher survival rates.
Kathy Yi from Sangamo spoke mainly about her recently completed project for her company in Brisbane. As a CFO of a small company of around 300 employees, she was challenged by budget constraints and had to wear multiple hats while running this project to completion. She was heavily involved in the construction process and also orchestrated all aspects of design and construction. She was able to complete a huge multifunctional facility in 13 months, for which construction started in December 2017 and was completed in January 2019.”
— Tuyen Nguyen, Director of Project Management at Delta PM