Back in February, I attended a week-long training course at Emerson’s training center located in Round Rock, TX. This course was recommended to me while I was leading a deviation investigation for a client, where the root cause was determined to be automation-related. The course was designed for those responsible for obtaining key production data, as well as maintaining, configuring, and troubleshooting a DeltaV distributed control system (DCS). I have worked with Python and Ruby in the past, but had no experience working within a DCS, so this course was perfect for me.
Since completing the course, I have led more deviation investigations, and armed with knowledge I’ve gained from attending the course, I was able have a better understanding of the automation aspects for the issues at hand. Additionally, I’ve successfully completed recipe qualification in a DeltaV environment, and have several more automation projects on the way.
In the three years I’ve been with Delta PM, not only have my managers always taken the time to understand my personal and career goals, but they are also constantly on the lookout for opportunities where I can achieve these goals. It’s one of the many ways Delta PM has supported my development and aspirations.
Thank you Delta PM for giving me this opportunity!
For the third year in a row, Delta PM participated in the annual ISPE Fun Day at Chardonnay Golf Club in Napa County as Silver level Sponsors. Our Aloha-themed hole was stationed at Eagle Vines Hole #7 and was staffed by Alicia Matthews, Allison Shaw, and Kelcy Cheng, who braved the sun to meet and greet the golfers who passed through.
Delta’s golfing foursome included Scott Kobayashi, Daryl Cheng, Mike Arzadon, and our friend Nigel. We had a great time passing by each of the sponsored holes on the Eagle Vines course and want to thank everyone for their warm hospitality, keeping us hydrated with water and beers and thoroughly entertained with contest games and freebies! We’re already looking forward to next year’s event!
“Last month, I attended my first PDA Northern CA Chapter meeting for a presentation on Contamination Control Basics. My Delta PM lead recommended it since my current project is supporting Environmental Monitoring for a local company.
The Wells Fargo's Market Street venue was excellent along with the good food (make-your-own tacos), beer, and great turnout of at least 50-60 people. Overall, this event was a great time to meet other industry professionals and learn something new.
Ziva Abraham, President and Founder of Microrite, Inc and a California-based technical consultant, presented at the event. She is a witty speaker, has a diverse set of experiences, and clearly knows her business. She began by stating that "Contamination Control is not a Paper Exercise." It has to be an organizational mindset. All the risk assessments in the world won't help if they are not based on data, facts, and good observations. As with any technical project, you have to Get Out, Look, and See what is going on. (Just like a validation project!)
Watch people gown, inspect the facility, and understand your EM sampling & data.
Ziva cautioned us about a common drawback — gowning selected by purchasing and not necessarily by microbiologists. A gown supplier audit should be standard practice. When you gown, check for tears, holes, and bad seams. Learn and follow the procedure carefully, and maintain good gown and glove integrity in the suite. Remember that any organism is an Objectionable Organism!
Like me, you may have used a lot of dry ice/WFI vapor for air-flow visualization. While dry ice may have its place, you must use a buoyant fog or smoke for good visualization. You can learn a lot from good smoke studies, so pay close attention to them and don't assume that all will pass.
Finally, EM and Sterility Assurance need to pay close attention to all isolated organisms. New, seriously problematic bugs come along all the time. Both aerobes and anaerobes are problems, and EM techniques must be robust for both types of organisms. For a robust program, make sure any simulated studies (e.g. plate exposure times) are conducted under truly representative conditions.
A big thank you to Ziva, PDA, and all the sponsors for a great session and event!”
- Lee Anderson, Sr. Quality Engineer at Delta PM
1. Why did you choose to join Delta PM?
Delta PM is more than just a company; it’s a community – built and upheld by driven, purposeful people with the goal of making a significant impact in the lives we touch and bringing the best we can to our field. The fact that this is a foundational understanding at Delta reveals a lot about the value and character of our firm. Delta PM is an organization that I am excited and proud to stand with, as we continue to create excellence and help drive our industry to greater heights.
2. How has your experience at Delta been fulfilling or different?
Having worked in many different disciplines in the biopharmaceutical field, from R&D and Quality to Process Engineering and Project Management, I’ve been on both the client end as well as the provider side of consulting prior to joining Delta PM. The difference is in Delta’s approach to providing the best in service and the intentionality in providing the right skills and resources to meet our clients’ needs.
Delta PM consistently delivers top-notch services, especially when it comes to customer focus and diligence in delivering results efficiently and effectively. There is great connectivity between the clients, consultants, and operations team, and the leaders of the organization are always open to discussion and improvement. This type of candid, constructive, and team-oriented atmosphere has been very refreshing to be a part of.
3. What does your role at Delta PM entail?
As the Director of Client Services for Delta PM, my role encompasses the client-facing side of the business, including project discussions, business development, and account management responsibilities. I partner with our consultants working at our various client sites to bring a thorough understanding of the Delta difference through our successful execution of project deliverables, as well as providing productivity and insight to our clients.
4. How would you characterize your team?
There is a saying on life and business:
“Your smile is your logo, your personality is your business card, how you leave others feeling after an experience with you becomes your trademark.”
The trademark that’s been created by our Delta team is remarkable and reflective of the initiative, drive, and acumen that the top talent in our industry hold. I feel very fortunate to be a part of the Delta community and work alongside such a wonderful team.
5. What’s your favorite memory so far with Delta PM?
We recently had a Delta Giants game night at AT&T Park, where many of the Bay Area team came out to enjoy the game and spend time together. The talks, laughs, and sitting under the lights at the stadium watching the world together will forever be set in my memory. We had an awesome encounter with Lou Seal, the Giant’s mascot, who visited us in our suite. And also, had a game ball that landed in the bleachers end up in the hands of one of our team members, who has been and always will be the ultimate Giants fan — now who can top that?
“A couple weeks ago, I attended the ISPE Biopharmaceutical Manufacturing Conference in Boston, MA. It was a very well organized event with engaging speakers, networking, socials, and facility tours. Many of the speakers focused on topics that included ATMP (Advanced Therapy Medicinal Products) manufacturing scale-up, how it compares to traditional mAb manufacturing, various issues around integrating different single-use technology platforms, and unique supply chain issues associated with delivering personalized medicines.”
“A highlight of the conference was an event called Balance for Better in Biopharmaceutical Manufacturing. The overarching theme was how to achieve better gender balance within our industry. A panel of speakers discussed building balanced leadership teams and recruiting from college engineering programs, as well as how to take ownership of your career, the process of finding a mentor, and how to take on responsibility and then deliver.
I enjoyed the breakout sessions within each table. My table in particular spoke to the group about the importance of pushing STEM curriculums as early as possible in the educational system, in order to achieve a balanced recruiting effort and address the significant gender imbalance which may already be established at the college level.”
“I also had a great time connecting with our growing Delta PM team based in Boston. Very excited for what our future holds!”
- Scott Kobayashi, CEO of Delta PM
Some of the few contractors I had worked with at the beginning of my career were highly-specialized team members flown in from across the States in order to fill a temporary void; then after a couple months, they would return to their normal lives. Now, desired contractors have shifted to becoming local employees who are experimental team members, where skills are tested for trust and permanence on the team, regardless of what company you might work for. So, developing with a team, no matter who it is comprised of, is an important skill for contractors.
I started my career in a contract manufacturing position, where I had a phone interview and was immediately placed. All of my paperwork was faxed or emailed and I never interfaced with the team in-person, until I was hired on as a full-time employee. I learned a lot from the position, but it became clear that my role would not develop and no change would come, regardless of being full-time or not. I continued to transition between full-time positions, as I outgrew the position.
Then along came Delta PM, who flipped my experience with consulting upside-down. My hiring process with Delta was the total polar opposite of my first. After 2 phone interviews, I was able to meet others who worked for Delta PM and hear their insights about the company; this experience was much more personal and reflective of how I would be treated as an employee of Delta. While working at my first site, I met up with the Account Manager at least every other week, and he took the time to get to know me. Over time, consulting with Delta gave me the chance to nurture my validation and project management skills and easily transition into new and exciting roles. I also recently received my PMP certification through Delta as well!
In the first 2 years since I started working with Delta PM, I have transitioned from a Validation Engineer to a Project Manager, and am now the Regional Lead for San Diego. Delta PM has made me a part of every team and treated me as a valued asset. I would not have had the chance to develop and grow as much as I did without the trust and confidence my teams have had in me!
Why did you choose to pursue consulting and how did you get into it?
I like the freedom and flexibility in taking on dynamic projects as a consultant. I also enjoy being able to network with many people and gain experience with a variety of systems that are important in the pharmaceutical industry.
Initially, I wasn’t aware of what consulting was. I discovered it as an option during my job search four years ago and was instantly interested in the traveling aspect. After my first project, I came to the realization that I had made the right choice. I have found that each project I take on has its own set of challenges and my troubleshooting abilities grow with each completion.
Why did you choose to join Delta PM?
I chose Delta PM after networking with Delta employees while I was on various projects. They had nothing but positive things to say about the company and it was apparent that they were satisfied with their job and unaffected by the pressures that one could feel on challenging projects. It was indicative to me of the support system that the company and employees provide — something I have now had the privilege of experiencing first-hand.
How has your experience with Delta been fulfilling or different?
Working at Delta PM has been a great experience, as consulting has been the catalyst to my personal and professional development. Growing up as an introvert, I never imagined I would end up enjoying the prospect of meeting new people and working in different settings. I have had the privilege of working with bright minds and cutting edge equipment, and contributing to the pharmaceutical industry. There’s always more to learn, which I greatly enjoy.
It’s also very apparent that there’s a lot of effort invested in developing a company culture at Delta that’s inclusive of us in the LA area. There are no reservations in reaching out to anyone and receiving technical advice. Working with great people encourages me to network for future project opportunities. All of these elements have empowered me to develop and seek growth in my career.
How would you characterize your team?
I have an awesome team! Everyone has been very welcoming, supportive, and open to addressing any questions. It’s been great working with like-minded, driven people who are willing to put in quality effort to get projects completed.
Any other Consulting best practices, tips, or career advice?
Anyone interested in consulting can be successful by being open to challenges, a new work environment, and being alone or in a group to complete a project. Project deadlines, people, and challenges vary and it’s up to the consultant to make the best assessment of the situation and move forward.
1. Why did you choose to pursue consulting?
Consulting offers a tremendous opportunity for professional growth and an undercurrent of merit-based opportunities that reward performance. There are so many niches in the industry that most consultants seem to find something that fits them perfectly. Pursuing a career in consulting is one of the most effective ways to build a vast and valuable network, since it allows you to work with multiple clients and stakeholders and build relationships across multiple organizations.
2. How did you get into Consulting?
I entered the consulting arena in 2014 through a networking opportunity with industry colleagues, and my first assignment was a project with an R&D Validation group working on Analytical Laboratory Qualification. This was a “stretch” role for me at this point in my career, so it was a challenge, as I was building upon a skill set outside of my initial comfort level. My skills were rather junior, but I was given the opportunity to prove myself. I quickly became the “go-to” resource on our team to take on additional projects and keep the team moving forward. I knew that I wanted to continue to push myself and develop my skill set, so it became apparent rather quickly that consulting was the correct career path for me.
3. Why did you decide to join Delta PM?
Delta’s mission is to deliver successful outcomes for our patients through exceptional work and going above and beyond our capacity to meet our clients’ expectations. With Delta PM, you are getting a network of Life Science professionals with a wide range of technical offerings, in addition to a successful track record of executing compliance-related projects and a reputation for delivering quality work on-time and on-budget. Delta PM’s core competencies as an organization align almost identically with my personal values as a biopharma consultant, so I was humbled that my reputation after 7 years of professional work experience enabled me to work for such an admirable organization.
4. How has your experience with Delta PM been fulfilling or different?
Employees at all levels within Delta are empowered to make internal recommendations or suggestions for improvement within the organization, which has been a very fulfilling experience. As a firm with an aggressive growth strategy to expand our footprint globally, there is an emphasis on teamwork with our current staff to ensure a collaborative effort is maintained throughout all phases of our approach for expansion. Delta PM’s trust and confidence in its employees is unlike any organization I have worked for and this is one of most motivating aspects of working with them.
5. What does your role at Delta PM entail?
I am accountable for providing technical leadership support to DPM staff at various client sites, as well as business development throughout the East Coast region. Some of my specific responsibilities include facilitation of new customer relationships, sales, and account management, RFP response, scope and labor estimate(s), and technical screening for evaluation of internal candidates. I am also utilized as a billable consultant for niche projects that align well with my technical background in Validation and Engineering.
6. What is your favorite company memory?
The 2018 DPM Holiday Party has been a very fond memory for me. Every member of the East Coast team came together and we were able to bond on a personal level and celebrate the year’s successes — the most notable success being the significant increase in headcount within the East Coast region compared to previous years.
7. Any Consulting best practices, tips, or other career advice you’d like to share?
Establishing trust with the client is one of the most critical factors to be considered, as it can be very difficult to re-establish good rapport with your coworkers if that relationship is compromised. It is also important to note that your behavior, attitude, and willingness to take on additional responsibilities above and beyond your assigned day-to-day tasks is often considered to be a direct reflection of the company that you represent.
A couple weeks ago, our SF-based Ops team went to Planet Granite for some team-building fun. Who knew that teaching one another to climb and hanging off walls could be so bonding? We had a great time cheering each other on and got some delicious bites and drinks at Radhaus afterwards. Can’t wait to see what our next team outing will bring!