1. Why did you join Delta PM and how has it been fulfilling?
I joined Delta Project Management as a entry-level Validation Engineer looking to learn the ins and outs of the Pharmaceutical industry. I've found working for Delta to be extremely rewarding. I feel that my career goals matter to upper management and that there is a coordinated effort on their part to assign me to projects that will further my career through valuable experiences and meaningful challenges. This attentiveness to my needs is refreshing compared to what I felt with previous employers, and that sort of personal employer-employee relationship translates well to Delta's client relationships as well.
2. What does your role entail?
My current role involves closing out the last dozen of 150+ qualifications for a large capital project that I've been fortunate to have the opportunity to be a part of from the beginning. Additionally, I have started working on new side projects where I am able to cultivate a positive client relationship while managing project hours and progress.
3. How would you characterize your team?
I would characterize my team as friendly, diverse, and supportive. Through the ins and outs of a project, we meet often to talk about the progress being made and any hang-ups that happen so that we're all on the same page about priorities and client needs. This dynamic creates an open atmosphere that allows for questions and suggestions. Overall, it feels like being part of a well-trained validation squad.
4. What is your favorite company memory?
My favorite company memory has to be my interview with Delta. Needless to say, I was nervous for my job interview, but when I finally met with Scott, Matt, and everyone else on the Delta crew, I felt like I was meeting with old friends. Even before we started the interview, we were cracking jokes and laughing. I knew immediately that Delta was the place for me.
Shawn has 19 years of BioPharma industry experience supporting drug manufacturing facilities as a Validation SME and Qualification Project Manager. His experience includes supporting large commercial capital projects, clinical projects, gene-therapy projects, and Contract Manufacturing Organization (CMO) projects. His specialties include Risk-Based Validation, Validation Master Planning and Project Management. He also has an in-depth background validating commercial and clinical filling lines, and has worked at Pharmacyclics, Lonza, Audentes Therapeutics, Boehringer Ingelheim, Amgen, Pearl Therapeutics, Allergan, Medimmune Vaccines, Genentech, Bayer HealthCare and Eli Lilly.
1. Why did you join Delta PM?
Delta’s overall culture, including their positive team dynamic, openness, and support for continuous learning, were the deciding elements for me. Over the past 20 years I have been a permanent employee on the client side and also an independent consultant. However, after working with Delta on and off for over 5 years and getting to know its owners, Delta was one of the few firms I considered joining. After 3 years of discussions with Feras, he couldn’t believe that I had finally made the jump to join them.
2. Why is your role fulfilling?
My role is fulfilling because I am continuously learning and meeting remarkable people. Delta has been amazing in giving me the reigns to run projects and support clients based on their dynamic needs. The level of trust and support behind me has been instrumental to my professional development.
3. What does your position entail?
My responsibilities vary day-to-day and month-to-month, but mostly consist of the following:
- Working on-site with clients to support projects
- Managing teams of Delta personnel
- Developing and supporting Delta employees
- Technical screening of candidates for various client projects
- Building out Delta’s internal training program
- Meeting with prospective new clients
- Providing SME support for continuous improvement with clients
4. How would you characterize your team?
This is the best part of working with Delta. The team consists of a wide age range with diverse skills and backgrounds. There are many experienced employees that provide continuous learning and there's constant knowledge exchange within our team. Also, there are many up-and-coming go-getters that are fun to work with and it's great to see them grow.
Having many independent problem-solvers, self-starters, and an efficient team that enjoys continuous learning is fantastic and keeps me on my toes.
5. What’s your favorite company memory?
My favorite memories have been when I was able to support smaller clients in the clinical phase and/or moving into the commercial phase to develop risk-based and efficient qualification programs. One of our recent clinical clients made it through a commercial PAI without any FDA correction actions for the qualification program and deliverables generated.
"I would like to share some new developments on how Delta PM has become more involved in our local ISPE San Francisco Bay Area Chapter, namely around three key achievements.
First, I am happy to announce that Delta's co-founder and Chairman, Feras Al-Zubaidy, has recently been made co-Chair of the ISPE SF Programs Committee. The Programs Committee organizes CEO Night and other events such as the Facility Tour, and develops technical content and themes for the local chapter to organize around every year.
Secondly, I am super proud of the turnout that Delta PM had at the latest Vendor Night at AT&T park that took place last month. I lost count of the number of employees who made it to Vendor Night, but I think it was almost 20! Thanks to everyone on the team who was able to show up and hang out at our booth and walk the halls for networking with the rest of our colleagues in the industry.
Lastly, Vendor Night was also a success in that our own Director of Validation Services, Shawn Sutton, gave a technical presentation on the proposed revisions to the Eudralex Annex 1, which was well received by the audience and resulted in some very good Q&A dialogue afterwards. Staying up on the latest industry trends is core to our DNA as a company, and we will continue to build on this presentation with others in the near future."
- Scott Kobayashi, CEO of Delta PM
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