This year’s ISPE Annual Meeting & Expo will be hosted at the Philadelphia Convention Center. The Exhibition will be held Sunday 11/4 from 5-7pm, Monday 11/5 from 10am-4pm, and Tuesday 11/6 from 10am-4pm. Our Delta PM team will be hosting a booth and is looking forward to meeting you!
Location: AC Hotel South San Francisco/Oyster Point Waterfront
1333 Veterans Blvd., South San Francisco, CA 94080
5:00 - 6:00 pm Registration and Networking
6:00 - 6:30 pm Dinner
6:30 - 8:00 pm Presentation Program Abstract:
In 2017 a cross-functional team of experts led by BioMarin’s Capital Project Management team, CRB, and Novo Construction completed a year-long mission to realize an idea into a GMP released and running Phase 3 gene therapy manufacturing plant. Come meet the leadership team from BioMarin, CRB, and Novo in a presentation and panel discussion as they look back on their journey together one year later.
Carl Albertson — Project Director, BioMarin
Logan Kelley — Sr. Project Manager, Design and Construction, BioMarin
Lisa Rappl — Sr. Manager, Engineering, BioMarin
Keith Life — Director of Gene Therapy Manufacturing Operations, Operational Readiness, BioMarin
Kurt Yanagimachi — Principal Scientist, Tech Transfer Lead, BioMarin
Evelyn Burbano — C&Q Lead, ADVENT Engineering
Kory Kaplan — Project Manager, CRB
John Voight – Project Director, Novo Construction
Logan Kelley — Senior Project Manager, BioMarin
Feras Al-Zubaidy — Executive Chairman, Delta Project Management
Anthony Bonifacio — Vice President, Project Management Advisors, Inc.
Michael Cooper — Sr. Manager Regulatory Affairs, BioMarin
Sue Cost — Director Business Development, ProPharma Group
Ralf Elsaesser — Group Director, Dome Construction
LeRoy Ginn — Vice President, ACCO Engineered Systems
Wei Huang — Principal, Newa Technology, Inc.
Jim Redenbarger — Principal Engineering Project Manager, BioMarin
Ted Reyes — Director, Project Management, Intarcia Therapeutics
Brian Vaughn — Director, Business Development, CRB
Last Thursday, the Delta Team attended the Oktoberfest-themed ISPE San Diego Chapter Vendor Night. The evening started with two great speakers: Dr. Harry Gruber, Founder & President of Tocagen, and Dr. John Hood, Founder & CEO of Impact Biomedicines. They both spoke about the challenges and development of each company’s cancer therapies. Since finding the cure for cancer has been a popular topic in the biotechnology world, these two speakers captivated the audience with the technology and experience they shared.
After the speakers, it was time for the vendor exhibition. This is the largest ISPE SD event and is also the only Vendor Night held outdoors. This year it was hosted in the Illumina i3 Courtyard, where the sidewalk and lawn were lined with over 70 vendors, overlooking the Miramar area. The Delta Team (Feras Al-Zubaidy, Scott Kobayashi, Colin Larsen, and Stacy Pham) spent the night connecting with new and old contacts around the courtyard and at our booth!
The night ended with a Raffle Drawing, for which Delta PM sponsored a set of amazing Crate & Barrel Beer mugs! Thanks to Stacy Sutton, Ashok Gopinath, John Ricci, Bethany Franks, Ray Jan, Vanessa Small, and Murtaza Kapadia for stopping by our booth; Johnny Gonzales, Fred Carmody, Nick Oberts, John Cott, and Jaymie Smith for introducing yourselves and playing our version of Roulette; and last but not least, ISPE for a great evening and San Diego for the perfect weather!
“I’m somewhat embarrassed to admit that my PDA membership lapsed well over 10 years ago. That wrong was righted when I rejoined the PDA late this summer and immediately plugged into the very active New England chapter. My first event back with PDA was this past Wednesday at the Bristol-Myers Squibb site in Devens, MA. They hosted a set of presentations from BMS experts on their latest facility design principles, process design, and closed systems thinking that drove their most recent facility.
Sanchayita Ghose, BMS’s Director of Process Development, spoke about key process redesigns that allow near-continuous processing of monoclonal antibodies. Rethinking the fed-batch vs. perfusion question not as an either/or but rather either/and allowed BMS to merge perfusion bioreactor stages with fed-batch stages to maximize protein productivity and set up downstream purification for continuous processing success. Downstream purification redesign involved multicolumn capture chromatography, tandem column linking to eliminate pooling steps, and auto-titration for low-pH viral inactivation. In aggregate, these steps allowed BMS to significantly increase throughput and productivity in a smaller footprint plant. This was an impressive example of selectively applying principles of continuous processing to drive bio-manufacturing success.
The second half of the program was presented by Richard Martel and Paresh Kurkure – both Manufacturing Support Engineers – who spoke about creating truly closed operations within single-use platforms. By refusing to accept conventional wisdom on the feasibility of closing certain process steps, Paresh and Richard were able to design fully-closed processes that seemed to be widely considered non-closable. These closed operations allowed the facility design team to maximize the use of controlled-not-classified space within the facility, thus making significant operational and overhead savings. Classified space within the facility is limited to operations that are not fully-closed and would have a much smaller classified space footprint than if the closures had not been made.
Both presentations were fascinating examples of thinking unconstrained by conventional wisdom or status quo, ultimately resulting in very real quality and productivity improvements that allowed BMS to continue bringing therapies to patients. I’m looking forward to further thought-provoking presentations from the PDA New England Chapter in the future.”
- Aaron Hubbell, East Coast Regional Director at Delta PM
1. Why did you choose to join Delta PM?
Having been in Recruiting for over 6 years, I’ve had the privilege of working at some great companies with some wonderful people. When Delta reached out to me about this new career opportunity, I immediately felt a connection to the team and to what Delta was doing as a company, and I knew that I had to be a part of it all. I was drawn to the fact that everyone was so proud of being a “Deltoid” (a pride that I now own as well), and that everybody on the team worked to achieve the goals of the company together, as well as celebrating individual wins. I have to say that this has been the best career choice I’ve ever made!
2. How has your experience been fulfilling or different?
Recruiting is fulfilling in so many different ways. Bringing new opportunities to talented individuals and providing great talent to important clients makes me feel wonderful about what I do, however; recruiting at Delta has brought another level of fulfillment to my job. Not only do I talk daily to people about a company that I respect, appreciate, and value so highly, but I also am able share with them how they can contribute to our goals and be a part of such an amazing team — my day-to-day no longer feels like work to me. It's like they say, “Find a job that you love, and never work another day in your life.”
3. What does your role entail?
As a Recruiter, I consider myself to be a kind of matchmaker for the career world. I have the distinct privilege of finding talented industry professionals and developing a strong relationship and bond with them, as they are interviewed and taken through the entire onboarding process with Delta. The best part is getting to meet these individuals at company get-togethers and hearing about how happy they are in their new roles and how much they love being a Deltoid.
4. How would you describe your team?
We may be small, but we are fierce! Our Ops team is a smaller team (about 15 of us), but this allows us to have a lot more interaction, collaboration, and connection to each other. This team is one that will be there for all of the wins and the struggles to celebrate you, help you every step of the way, and encourage and motivate you to meet your own goals too. I couldn’t ask for a better group to spend my days with!
5. What is your favorite company memory?
I haven’t quite hit my one year mark yet, but my time with Delta has already been filled with some awesome memories. I’d have to say that my favorite memory thus far was the SF ISPE Vendor Night. I got to see our competitors in action (though they’ve got nothing on Delta, in my opinion), meet most of our consultants that I had heard so much about, and also spend some quality time with the entire team afterwards, bowling and having a blast together. Each person’s title and role didn’t matter; we were all just one big family that genuinely enjoyed spending time together — a true representation of the culture of Delta and just a part of what makes this company the best place I’ve ever worked!
When our Delta recruiting team speaks to new candidates, they are often asked, “What is the difference between a Validation Consultant and a Validation Engineer/Specialist at my current biopharma company?” This is an important question to ponder because consulting is not for everyone. The importance of having the self awareness to know whether or not consulting work is the right fit for you cannot be overlooked.
There are three key differentiators to consider:
1. Do I Have the Technical Skills?
Never forget that as a consultant you (and your firm) are being paid to bring skills and expertise that the client organization does not possess. This position requires a strong technical background to “sell” to the prospective client and add value to their project. Relevant skills include commissioning and qualification experience, protocol development and timely execution, temperature mapping studies, cleaning validation, data integrity risk assessments, technical writing, validation planning, and so on. Your purpose is to provide expertise and knowledge, and the client doesn’t allocate resources to providing training on the basic fundamentals. You must identify and refine your core capabilities and bring those to your clients’ projects.
Understand that your success as a consultant requires the ability to roll up your sleeves and help the client however you can – and in that, you can find ample opportunity to learn new skills and round out your technical expertise. You may be at a client site as a technical writer developing validation protocols, but the client is shorthanded one day and needs help performing executions associated with a protocol you authored. This would present you with an excellent opportunity to gain some hands-on experience and also show the client you can play multiple roles within their project team.
Note: A willingness to help out in other areas can lead to expanded skills and success; but this needs to be approached carefully. Don’t take on additional tasks until you’ve completed all of your assignments in your current scope of work. Your client should approve this support in advance. It may be nice that you helped with an unassigned task, but you’ll have a very unhappy sponsor if that unassigned task delayed the critical tasks within your scope of work.
Ultimately the more diverse your skill set and expertise, the more likely you will be to land higher visibility projects. For more information, read Adrienn Prezenszki’s excellent article on technical skill sets for Validation work.
2. Do I Have the Soft Skills?
Key soft skills that will allow you to thrive as a consultant include learning agility and intellectual curiosity (are you constantly learning new skills and asking questions?), personal integrity (adhere to the cGMPs so that you can assess if a request or activity represents a possible violation), a value-centered mindset (the client is paying a lot of money for your time, so every billable hour should clearly bring value to the client), flexibility (different doesn’t necessarily mean wrong so be open to new approaches where they make sense), and PMA – positive mental attitude.
Establishing trust with the client is one of the most important factors to be considered, as it can be very difficult to re-establish a good report 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 you represent.
3. What’s My Preferred Lifestyle?
One person’s stability and predictability is another person’s stifling boredom. In-house employment with the client can often lead to greater certainty, but the flip side of this may mean being siloed in a singular function with limited opportunities for growth and fewer project-related roles to diversify your skills. There’s no right or wrong choice, but you must understand and recognize what is important to you, your career, and the lifestyle you choose to pursue.
Consulting can be exciting and rewarding, as you can travel to different parts of the world and learn an incredible amount in a short period of time. You mustn't overlook the realities of long periods away from home and perpetually feeling like a “visitor” at your client’s work site, however; consulting with the right employer can lead to fast career advancement and put you in greater control of your professional development.
At Delta Project Management, we pride ourselves on the quality of our service to our clients, the professional excellence of our staff, and our reputation for consistently delivering project success. We empower our consultants with challenging projects, and allow them to identify specific skills they would like to strengthen and develop and also travel to new geographies they would like to experience. As you consider a career in consulting, keep in mind that your thoughts will change depending on where you are in your professional and personal life.
If Validation Consulting is still attractive to you after giving some serious thought to the points listed above, feel free to apply to our current openings or reach out directly to us. We are always looking for talented and driven people with the right mix of expertise and personality, as we're expanding our diverse portfolio of clients where you can grow your career.
A couple weeks ago, I attended the ISPE SD Chapter “Without people, there is no product” Program and Inovio Facility Tour. Although the outside looked like any typical warehouse building in Sorrento Valley, the foyer opened up to a massive open seating theatre and break area. It was wonderful how friendly and welcoming the open concept of the room was. There were many new and familiar faces in the crowd that night who enjoyed the awesome barbecue provided.
The Technical Session started off with Steve Kemmerrer, Inovio Pharmaceuticals, presenting on the expansion of Inovio in Sorrento Valley and the need for the open design of the new building by the device team. Nathan Manczarek, Inovio Pharmaceuticals, expanded on Inovio’s culture with a presentation on how he changed the stigma and dynamic between the Quality team and everyone else, and how it prepared the company for audits with ample documentation and exceeding participation by cross-functional teams. He expanded on how the perception of Quality team as “cops” on the floor really made a difference in day-to-day operations. He worked on changing the perspective of the quality team as customer service representatives. Kent Porter, Porter Leadership, reminded the crowd that every work dynamic requires understanding ourselves and others to allow for progress and breaking the sound barrier and vocalizing concerns helps build that understanding.
Nathan’s and Kent’s presentation resonated with me, because over the past several months, Delta PM has invested time in identifying each of the operations team member’s way of thinking and making decisions, and acknowledging the importance of understanding each other’s thought process. Although Nathan’s presentation was specifically about steps taken for the company to better accept the Quality team and ideology, I understood that his strategy could be used in all aspect of business and personal life. Kent’s philosophy aligned with Nathan’s presentation, but took a different approach of exhibiting to the crowd. Kent kept an open conversation, told us anecdotes from his life, and explained the thought process of himself and others in the stories.
The event ended with a demonstration of how Inovio’s 5PSP works and all the safety measures installed to the device and a tour of the facility. Every space felt as open as the common area! The manufacturing area and warehouse even had space for growth.
Thanks Inovio Pharmaceuticals for hosting the event, taking the time to present, and showing us around the facility. What a great night!
- Stacy Pham, Validation PM & SD Regional Lead
"Delta PM attended the Annual West Coast Chapter PDA Women in the Biopharmaceutical Industry event for the second time this year. I attended this year's event, hosted at Genentech, with our Validation Engineer, Veronica Torchia. The panel moderator, Lori, was engaging and had her own unique story about her career path. The panelists all had a diverse range of backgrounds, educations, career paths, and career goals. It was inspiring to hear from the women about their setbacks and their perseverance. There was energy in the room which everyone could feel. The audience asked probing questions to which all of the panelists had useful advice on how to navigate the workforce.
Events that focus on the unique women's perspective are vital; this was proven when one of the men in the audience asked, "Since you are all so accomplished and powerful, does this mean the glass ceiling has been broken?" to which all the women looked at each other knowingly. The panelists did not stray away from discussing tough subjects and sharing their honest experiences as a women in the Biopharmaceutical Industry. Hearing from women in all different phases of their careers was empowering and motivating. Delta PM is proud to support the growth of women in this industry. As Lori closed out the event, she summed it up well, "We laughed, we cried. I know I had a great time here."
- Hannah Sherman, Operations Manager at Delta PM
"The PDA women in Biopharmaceutical Industry event was an amazing experience. The six distinguished panelists touched on several topics, such as their personal career paths, mentoring, broaching tough subjects with managers, how to take a big career leap, and of course the glass ceiling. Looking around the room, it was clear how relatable so many of the panelists personal experiences were to many of the attendees.
One of the notable themes from the night was taking the next step or the big career leap no matter how scary it is, and to stop telling yourself that you’re not good enough to succeed. Director of Quality at Boehringer-Ingelheim, Catherine Kavanagh, gave some of the best advice when finally making that big move of “breathe through the terror,” and to give some time time and space of at least a month prior to evaluating whether the move was the right decision. Another notable theme was that it is never too late to change career directions or pursue something else that you’re passionate about. All panelists encouraged everyone in the room to follow their passions. Overall, the event addressed a lot of career questions or concerns that all people have at some point in an extremely inspiring and uplifting way."
- Veronica Torchia, Validation Engineer at Delta PM
I joined Delta in September 2017 and recently finished my first assignment at Bayer Healthcare. My role consisted of providing general engineering support to the Site Facilities Department. I supported the building owner by conducting daily facilities walkthroughs, generating energy control procedures, creating and submitting forms to get spare parts into SAP, walking down and red-lining P&ID drawings for a purified water system, and doing many other tasks. It has been a rewarding experience to gain this work experience and learn about the efforts that go into the daily operation and maintenance of a building.
I was first exposed to the consulting industry when I joined my previous employer upon graduation from UC Irvine in 2014. What attracted me to consulting was the opportunity to be exposed to different companies and work in various roles. Like most college grads, I didn’t know exactly what I wanted to do. Consulting seemed like a great way to help me figure that out.
Through consulting, I’ve worked at small, mid-size, and big companies. I’ve worked on assignments independently, and also with a team of 10 individuals. I am always on my toes, constantly learning, and rarely find myself plateauing. This is the beauty of consulting – you get to explore assignments of different scopes, lengths, and environments.
My experience with Delta PM has been rewarding so far. Delta has allowed me the opportunity to work at one of the biggest names in the biotech industry, and understand how such a company operates on a large scale, including their benefits and drawbacks. Although I do not personally have any Deltoids on my team, I was welcomed with open arms by the Delta validation team just a few desks away. It’s a great feeling to know the Delta family is always around!
During the ISPE LA Latest Technology in Containment Considerations for Conjugation and Fill Finish of ADCs Using HPAPI Toxic Multi Product Facilities, we learned that the use of conjugated proteins and toxins target the cancer cells while minimizing collateral tissue damage. The idea is genius, but the manufacturing the toxins and the prevention of unexpected impact and reaction is still developing new ways to minimize negative impact and streamline production.
Richard Denk (SKAN) expanded into the technology and importance of isolators for toxin manufacturing and filling. Michael Molony (Ajinomoto Althea) dived in to the significance, challenges, and potential solutions for analyzing product conjugation concentration, polarity, size, and distribution, to name a few, and manufacturing considerations for a CMO. Allen Ader (Safebridge) revived the group while interjecting with jokes during his presentation, regarding the safety considerations for exposure and use of product in patients and employees. John Dumas (IPS) closed out all of the presentations with his project to segregate one site to manufacture drugs of high and low potency, using physical and airflow boundaries.
It was great mingling with all those that attended and meeting the intellectuals that spoke and the great team that helped make Ajinomoto Althea’s new filling facility. Thanks to the welcoming staff at IPS for a great spread and hospitality.
- Stacy Pham, Validation PM & San Diego Regional Lead at Delta PM