by Dan Kenny, Northeast Engineering
After what seemed to be weeks of rain, the weather finally broke and the sun shined for everyone at the Annual Spring Golf Outing. The event was held on May 11 at Ledgemont Country Club in Seekonk, MA. With the temperature in the mid to upper 60's and minimal cloud cover, it was a picture-perfect day for golf and networking with fellow Chapter Members and guests. The course was in great shape as always and the staff at Ledgemont did an amazing job of making us feel welcome for the second year in a row.
|Ledgemont Country Club in Seekonk provided the venue for this year's Spring Golf Outing.|
With a sold-out event again this year, the golfers were sent out with a full stomach thanks to an amazing spread for lunch at the clubhouse. Once on the course, Jim Grunwald (DPS Engineering) and Sherwood Butler (TRIA) started the festivities by crushing the golf ball straight down the fairway all day long and showing the rest of the field how it was done. Loud cheers from the amazing shots and groans from the near misses were heard all day long, sprinkled in with many, many laughs. As groups completed their rounds and headed for the clubhouse the laughs got louder and the stories got better over a beverage on the deck overlooking the beautiful course.
|The course was in near perfect condition, as was the 19th hole where golfers gathered to celebrate their great (or not so great) round.|
Once the last groups made it to the clubhouse, everyone made their way to the dining room where a fantastic buffet with a full carving station awaited the golfers and guests. After dinner was served, the awards took center stage. Awards were handed out for first, second and third place foursomes, longest drive (men/women), straightest drive (men/women) and closest to the pin (men/women). There was also a putting contest held along with a number of amazing raffle prizes. To end the event, there was a 50/50 raffle won by Nick Hanney, raising $575 for the Jimmy Fund ( www.jimmyfund.org ) which solely supports Boston's Dana-Farber Cancer Institute, raising funds for adult and pediatric cancer care and research to improve the chances of survival for cancer patients around the world. Congratulations to all our winners!
|Just a few of the 33 foursomes who enjoyed the day's festivities...|
Closest to the Pin
The Social Committee would like to thank everyone who attended and helped make the tournament a big success, and the many sponsors who made the event possible: Albireo Energy, A/Z Corporation, Boston Analytical, Commissioning Agents, Crosspoint Engineering, DPS Engineering, ICQ Consultants Corporation, Northeast Engineering, Reflex Lighting Group, R.W. Sullivan Engineering, Siemens Building Technologies, Superior Controls, TRIA and Ultrafiltronics - A Wilkinson Company. Your support is greatly appreciated. The committee would also like to thank Erin and Katherine from the Chapter's admin team for helping with the organization of the tournament before and during. You are a vital part of our success!
Hope to see everyone at the "Sold Out" Summer Golf Outing to be held at Lake Winnipesaukee Country Club on August 8. Also, be on the lookout for the Fall Social at Harpoon Brewery on October 27. See you soon!
by Joyce Chiu
The May educational program took place on the 19th at Shire Pharmaceuticals in Lexington and featured "Single Use: From Toddler to Adolescent" along with tours of Shire's Pilot Plant Operations (PPO) that highlighted single use technology.
After a networking reception with excellent food, 85 participants entered the large lecture hall where Chapter President H. Steven Kennedy welcomed the crowd and thanked event sponsor CAI and Shire for providing the venue and tour. Meeting Manager Chris Opolski then introduced the first speaker, Mark McElligott, Partner/Principal Process Engineer, Process Design Solutions and PDS Sandbox.
|The May 19 "Single Use" program and tour at Shire attracted a cross-section of Chapter Members.|
After describing some of the initial promises of Single Use Technology (SUT) in its toddler days, such as savings of 50 percent in capital investment and up to 30 percent in operational costs, Mark introduced the pitfalls that early adopters of SUT have since encountered. These include establishing SU component and characterization requirements, the criticality and relevance of such requirements for manufacturing and process development, the need for a technical quality agreement (TQA) with key vendors, as well as a cross-functional team focused on lifecycle management of SUT, including vendor change notifications.
Mark then expanded on each of these, the hidden costs associated with the implementation and integration of SUT, and provided detailed examples of areas that require subject matter expertise - materials science (in plastics), extractables and leachables, sterile tube welding, sealing and aseptic connection devices, gamma irradiation, and the larger business process of supply chain and vendor quality management.
He concluded his presentation by summarizing his recommendations - a site and process program for single use technology, a dedicated cross-functional team focused on SUT program management, and contingency plans for SU suppliers to stay on top of change management. With these in place, the benefits of SUT can be maximized. A brief Q&A followed during which Mark was able to provide additional detail.
|(l to r) Meeting Managers Joyce Chiu and Chris Opolski with speakers Mark McElligot and Brad Ebel.|
Chris then introduced the second speaker, Brad Ebel, PPO Upstream Manager, Shire Pharmaceuticals. Brad's presentation focused on the actual implementation of SUT with two technical case studies: Centrifuge redesign and Alternating Tangential Flow (ATF) redesign, both of which were required to create a semi-continuous (perfusion) biologics process based on SUT.
For the centrifuge, Brad outlined the initial challenge, why equipment had to be re-designed, how they worked closely with their vendor, and step by step, how the equipment was entirely revamped. He showed numerous photographs, which fit nicely into his narrative, and the audience got a very clear sense of the technical challenges, the trials and tribulations, and the eventual success. He also showed graphs depicting performance data leading to the eventual order of magnitude improvement in process performance. After years of effort, centrifuge is now one of the most reliable pieces of equipment at the PPO, which has been contamination free for over 4 years!
While centrifuge has been conquered, a new technology, ATF, has arisen. ATF offers distinct advantages, not the least of which is that it's much gentler on the cells, decreasing their stress while increasing viability and productivity. ATF is also a continuous process, efficient, scalable, and easy to use. Brad then went into more detail about how ATF works, its alternating pressure and exhaust cycles, and shared some process data. ATF has been introduced to the PPO with two vendor systems, Hyclone 50 L and Xcellerex 200 L bioreactors. Some of the challenges included warped plastic flange connectors, and stainless steel to C-flex molding, which were among the lessons learned.
Brad concluded his presentation by offering tips for evaluating new technologies. The most critical is to engage with a partner who is willing to make improvements on their equipment. He also provided the audience with guidance that SUT is not plug-and-play, it requires careful consideration for the human factor and an integrated approach, as Mark also emphasized, involving Supply Chain, Facilities, Engineering, Safety and Quality early in the process. The audience again asked many questions, which continued until after the formal ending of the evening.
Our two speakers, with two different yet complementary perspectives, one with an overall view, the other with practical case studies, provided the audience with intriguing insights into what it took to embrace and learn from failure and experience, while Single Use Technology has grown from a toddler to an adolescent. It was not only an educational but also a highly entertaining evening!
The Chapter would like to thank our excellent presenters and tour guides, event sponsor CAI, our generous host, Shire Pharmaceuticals, and Meeting Managers Joyce Chiu and Chris Opolski for making this very successful event possible.
by Zeb Jones, Sanofi Genzyme
Sanofi Genzyme has over a hundred current members in the Boston Area Chapter that participate in Chapter events, serve on the committees, and volunteer in various capacities. To further strengthen the ISPE presence at Sanofi Genzyme, the Chapter's Membership Committee organized a membership drive at the company's Framingham Biologics Support Center on June 1. The purpose of this event was to familiarize Sanofi Genzyme employees with ISPE and illustrate the many benefits of membership. In addition, flyers for several summer Chapter events were distributed.
Katherine Batten from the Chapter's admin staff and Membership Committee volunteers and Sanofi Genzyme engineering manager Zeb Jones and engineer Mike Murphy set up the ISPE booth in the 68 New York Avenue cafeteria during the lunch hour when employees would have the time to stop and chat. They distributed ISPE membership brochures and flyers describing upcoming Chapter activities. Potential members were excited to hear about the professional development and career advancement opportunities and a number of them provided their contact information for follow up on joining ISPE.
ISPE Membership Committee volunteer Mike Murphy greets prospective member Jeffrey Lu at the Sanofi Genzyme Framingham Biologics ISPE membership drive.
ISPE and the local Chapter provide a platform for New England pharmaceutical professionals to exchange practical knowledge with their peers, keep current on the latest trends in the industry, brush up on the basics, advance their technical knowledge, or simply meet and mingle with industry professionals who speak their language. We do this by hosting networking and educational events, career advancement workshops, professional publications, and by organizing the largest one-day life sciences Product Show in New England.
If anyone would like to help the Chapter attract new members by hosting a similar membership drive at their own company, please contact Membership Committee Chairs Ying Cai at email@example.com or Samir Gondalia at Samir.Gondalia@pfizer.com .
by Mina Jung, DPS
We had a great turnout for this year's Summer Social and Volunteer Appreciation Night, also known as the 2016 Hawaiian Luau on Quincy Bay. Squantum Yacht Club provided an easy breezy venue with amazingly friendly and accommodating staff. Our ISPE friends sipped drinks and mingled on the deck against a spectacular sun setting over the water and city views. The X-Isles provided mellow live steel drum and guitar music to accompany the festivities. The ice cream sundae bar, manned by Brett-the-Trooper-Scooper, provided our guests with welcome relief from...uhm...the Mai Tais, the perfect weather and the great food. Well, he was a welcome addition to the night, anyway!
|Mother Nature provided perfect weather, ocean breezes and an awesome sunset to accompany this year's Summer Social.|
Very much in the spirit of the evening, our expert pit masters served up a whole roasted pig (brought to the club in a travelling smoker) and served up fantastic BBQ fare, sauces and sides. We raised $450 for the very worthy charity, Community Servings, with special help from raffle winner Aarash Navabi who generously donated his winnings to the cause. And runner-up raffle winners Jack Campion and Matthew and Abigail Hildner took home tickets to a Red Sox game. It was a lovely event that drew both new and old friends. If you didn't make it to this one, we hope you'll join us next year.
Special thanks to our generous event sponsors: Albireo Energy, Boston Analytical, DPS, Hereva Consultants, JENSEN HUGHES, LJStar, New England Laboratories, Northeast Engineering, RW Sullivan, SPEC Process Engineering, and TRIA. And to Mother Nature for the perfect weather, the ocean breeze and the awesome sunset!
|The dress code for the evening matched the Hawaiian luau theme and Chapter Members were happy to oblige!|
by Christopher Ciampa, Thermo Fisher Scientific
Summer is fast approaching and that means we're ramping up to provide you with some fun social events to look forward to! This year, the YP's had a bit of a lull in May and June but you can expect the excitement to heat up as we head into the summer months.
Make way for a trip to Fenway Park on Thursday, July 21 - this year's Red Sox outing is fast approaching! Come watch our fellow Sox take on the Minnesota Twins! Before the game, we'll meet at Blazing Paddles for food, drink and camaraderie. Tickets are only $25 for Chapter Members ($30 for non-members) and include the game and the pre-game meet-up. They're going fast, so don't delay, sign up today!
Our annual flagship event, the Boston Harbor cruise, is scheduled for Thursday, September 8, with details still being finalized. We're currently working with food vendors as well as a possible band in order to make this event the best yet, so keep an eye out for updates! Also in September, from an educational perspective, we are looking to partner with WPI on an evening event during their 5-day seminar on bioreactors. This would give our Student and YP Members a chance to see and learn about the bioreactors. Keep an eye out for details regarding this great opportunity.
Also in the planning phase is the "YP hour" at the October 5th Product Show. This year we're looking to offer some education in lieu of the social festivities we have sponsored in the past. We are considering a resume review session for students and young professionals entering the industry or in the process of changing jobs, as well as a panel discussion. Both will help students and young professionals gain the skills needed to land a job in our industry. Later the same month, we are hoping to host an event in partnership with the Tufts Gordon Institute. The likely topic will be a soft skill such as project leadership. Stay tuned for more information on both of these exciting events as October approaches.
Looking toward the end of 2016, we are planning dual track educational program for the November timeframe, potentially at Northeastern. The YP track will be "Regulatory 101: Jargon for Engineers - QC, QA, QS, RA: Really? Why?" Two speakers are currently planned, one from a pharma manufacturer and the other from a consulting firm. More information will follow in the coming months.
As always, we want to hear from you! If you have any suggestions or would like to attend one of the regularly scheduled YP committee meetings, please don't hesitate to reach out to me ( firstname.lastname@example.org ). Happy summer and go Red Sox!
by Brian Hagopian, Clear Water Consulting, and Paige Kane, Merck
The Chapter has been extremely busy helping students find employment, whether it's a summer internship, co-op or full-time position for students graduating and entering the work force. The Chapter offers local life science companies a free job posting service to help them fill vacancies. Check out the "jobs and internships" section of the Chapter website and "like" the Chapter's Facebook page to receive notifications when positions are posted. With the cooperation of several local firms looking to hire students, we have posted over 100 positions for our Student Members this spring! Remember, you have to be an ISPE member to access these positions.
The Chapter's Scholarship Program continues to help Student Members pay for the cost of their education. The most recent application period has closed and recipients will be selected and notified over the summer. The next application deadline is November 1. Applying is easy and your chances of receiving a scholarship are much higher than you might expect. You can apply here for the next round at any time prior to November 1 but don't wait until the last minute - a written referral needs to be submitted by the deadline.
While college campuses are taking a break over the summer, we will be working on our strategic plan for the coming year. We will be holding a brainstorming and planning session on July 27 to put plans in place for our Student Members for the upcoming year. All input is welcome, so please sign up and attend if you'd like to contribute your ideas.
If you need any further convincing of the benefits of being part of an active, professional network, check out our latest video and hear directly from some of our Young Professional Members at https://vimeo.com/148636910 . And remember, Student Members can attend educational programs and YP social events for free! Hope to see you on campus or at an ISPE event soon!
Page last updated: 13 July 2016