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.