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LT 1 Upper Valley Stryker Biotech Summary 11-18-09

We visited Stryker Biotech to learn more about employer needs for 21st century learning. We learned about the product, the work environment, hiring and employee retention practices, and how they advertise for employees. We also learned about the product they make, how they make it, and some of the costs associated with production. We toured the plant, and had lunch with the employees. We asked them what they like about their jobs, and what they want our students to learn. We also asked what had inspired them to become scientists, or to work in a facility that makes a medical product.

Biotechnology is the process of making human proteins in large quantities to give to patients because they cannot make it themselves or because they need more than they can make themselves, as with insulin for diabetics. Stryker Biotech makes a product called Osteogenic Protein # 1 (OP-1). OP – 1 is a drug for people with injuries of the bone that haven’t healed with traditional medical interventions. It can be used as an implant or as putty. The usual dose is 3.5 mg and this costs the buyer $5,000. During our tour we learned why it is so expensive.
Getting approval for a new drug has a very intricate procedure, and takes a lot of time. Each reason for use has to be researched separately. Their approval statement is ‘Indicated for use as an altenative to autograft in compromised patients requiring revision posterolateral (intertransverse) lumbar spinal fusion.’ This is a very restrictive indication statement because this is the only application they have tested in clinical trials. It may be useful for other conditions like arthritis, but they can’t legally promote it for that. Off label promotion is prohibited. There are huge lawsuits for that practice. They have a strong code of ethics based in law. Customers are surgical centers, and hospitals. Surgeons are the ones who use the product.

Joe DeCocco, Director of Human Resources, spoke last. There are two Human Resources workers at the Lebanon site, but a larger department in Hopkinton. Some of the functional systems and career paths at Stryker include Manufacturing, Manufacturing sciences, Engineering, Quality Control, Quality Assurance, Quality Assurance documentation, Operational excellence, Plant services, Human resources, Information systems, Regulatory compliance, Validation, Environmental health and safety, and Quality systems.

He told us about their hiring and retention procedures. They employ a science and engineering team of 30-35 people and have a total staff of 145. They have a stable work force because of their careful hiring practices. They ‘like to hire home grown people’. They know they like it here, and when they bring people in they look for those who enjoy winter sports, hiking, and outdoors life. The management team is made up of people from this area and most have been here 15-20 years. When hiring, they do background checks and reference checks. They also use a profiling tool from the Gallup organization which asks questions based around 12 different themes, looking for what tools you might have that make you effective in your area. The hiring is done by cross functional teams. Skills are an important component to the hiring process, but behavior and competency piece are also very important. Turnover is 5% or less because they are extremely selective about whom they hire. Most of that 5% were from a different part of the country. It wasn’t a good fit.

To keep employees, they recognize achievement. They have Service awards for 10, 15, and 20 years of experience. They have a program for employees to recognize each other for a job well done, for supervisors to recognize good work, and for company wide recognition for big ideas that change the way they do things. There is extensive on the job training for entry level positions. It takes 12-14 months to become competent in any role in the company. They get great benefits, because they leverage all employees (8500 in the US). They offer 100 % reimbursement for any education relating to their product, including texts, and they promote from within before going outside to find someone. There are a lot of ways to get into a job, and they encourage a lot of cross training so as to be able to maintain employment in a cyclical process. There is a shutdown every year and techs are encouraged to take vacations then. Several people we met said ‘We all really like each other.’ Employees at our group lunch all agreed that it is a great place to work.
They advertise for future employees at Monster.com, biotech sites, local colleges and universities, the Valley News, the Rutland Herald and Concord Monitor, Associations or job boards. They run paper ads on Sunday, if they are looking for multiple positions. These are usually big ads.

The Product

Our first speaker was Margaret Worden, who is the Director of Manufacturing Sciences and Engineering. She told us about the product and the manufacturing process. She told us about some of the costs incurred while developing, testing, and producing the product.
Margaret was inspired to this work by a high school math teacher. She always liked working with her hands, and in elementary school she liked hands-on projects. She feels that play is very important to learning, as is problem solving from the beginning. She encourages people to try things. Most of her hands-on projects were in college, and she wished there had been more as she was in public school.

OP-1 is a product that has been engineered using both biology and technology. It was 38 years in research and development. It has been written about in over 600 peer reviewed publications, and is the result of many different research projects. Their complex process includes many steps, and requires a very clean environment. They start with a small vial of a cell extracted from Chinese Hamster ovaries. They use chemistry electronics and mix it with bovine bones and human stem cell DNA. Through several iterations, the product grows to fill a large vat. After that a chemical process is used to extract the OP-1. A chemical process of several steps results ultimately in this product that is able to heal bone injuries that are resistant to other healing methods. This process takes nine months. They end up with a product volume that is about the size of a granola bar. This is worth over 2 million dollars.
Part of the cost is from development and testing. After a discovery, (which has a 1% chance of proceeding) Phase I testing costs about $2-5 million, and takes a year and a half. There is a 15% chance of moving ahead from this phase. This phase involves using the product on a few people in selected locations. Phased II costs $40-8- million and takes three years. There is a 60% chance of proceeding to Phase III which costs per $100 million and takes five years. This has a 70% chance of approval. Any one of these phases can lead to the necessity for more research and development.

Once they are in the manufacturing process, if at any point along the way the product becomes contaminated they have to throw it all away. Clean rooms are really clean. There are different levels of clean, and there is a pressurized air lock between the hall and the clean room. In some clean rooms you need to wear two layers of protection and you can’t have any skin showing. There is a lab in the building that is responsible only for testing surfaces, air, and water in the plant. They work on a rotating basis to cover every area in the plant at regular intervals.
They check every surface in the entire plant every six weeks for sterilization. Everyone who works there has the capacity to contaminate the product, and so their procedures are extremely careful and monitored constantly.
A sign on one wall said ‘It is easier to do it right the first time than it is to explain why you did it wrong.’
OP-1 is sold in several countries, and so Biotech has to meet regulatory standards for each. They are usually in the process of being scrutinized by one country or another, and this process requires a lot of paperwork verifying everything they do.


Tom Panella, Facilities Engineering Project Engineer spoke second. His group manages what they call ‘FUSE’, (Facility, Utility, Systems and Equipment.) His group is responsible for making sure that all of the machinery and infrastructure works smoothly. His group also has to maintain a sterile environment.
He talked about the many careers for people who have finished a Vo-Tech program. They hire electricians and plumbers, as well as general maintenance people. They hire locally exclusively because it is possible to do so.
He also told us about other factors that contribute to the cost, having to do with the facility. It cost over $60 million dollars to build the facility. Last year, electricity cost $160 K, propane $140 K, and water $25 K. They maintain back up systems, too. Every year the city of Lebanon asks them to go off the grid during peak electric season. They use their back-up generators to make this possible.


Lunch

At lunch we met with employees from several departments. We asked what skills they need to be successful, what helps them now that they learned in elementary school, what they would like us to teach younger students in order to be successful in the workplace, and what they like about their jobs.

They said In biotech people have to be really detail oriented, and you need to be good at anger/stress management. These are very stressful jobs because so much rides on each batch.

Employees at Stryker score high in responsibility in the Gallup poll survey. Everybody feels like they own what they do.
Q: What did you learn (or what would you like to have learned) in elementary school that helps you now?
A: Be a lifelong learner. Ask questions. Think for yourself. Be excited about learning. You have to be able to think about what skills you have that can solve the current problem. Everyone said they value the range of things they do every day.
Teamwork is really important. Learn how to be on a team. Learn to work in a team. Working in teams is more engaging. Form as many relationships as you can. Make connections. Networking, relationship building communication is essential. Being greeted in the morning makes you feel like you belong and are valued.
Ask for help and help when asked. Learn good listening skills. Share what works well, be open to new ideas. Learn from mistakes. You have to be able to feel safe making mistakes.
Practice is what makes you good at what you do. Do your homework. It is all about how much time you put into it. You have to be willing to work hard. There are a lot of different ways to use your skills. Skills are transferable, especially social skills and character strengths.
Teachers had the passion to make me want to learn more. Teachers who are interested in me make me want to learn more. Remind children of what they have already learned. Everyone starts somewhere.

Education connections
• Job Shadow day, 8th graders
• They go into middle schools and high schools to talk about working in biotech industry.
• Bow High School comes in the spring, Lebanon high school, Margaret and Josh went to Lebanon and Claremont.
• Contact Joe DeCocco through Jen to get people to come out and talk with students

Reflection:
• Project based learning will be a harder sell in a traditional school.
• LT organization is looking for ways to expand, and would like us to spread the word. We brainstormed ways to do that.
• Rivendell is working to restructure education to include more PBL.
• It was amazing to hear about how important people skills are. No one said they wish they had learned more math or read more books. They all talked about getting along with other people and working as a team member. Basic communication skills were highlighted.
• How can we get this information to our students?
• There are so many different types of jobs in this company. People with all kinds of backgrounds can work here. Even the electrical systems would be a hook for some students. Could they do a field trip to the plant operations unit? (Heating, plumbing, electrical) To help them to value what they are doing on a different level. They have already devalued themselves at Riverbend, but could this light a spark?
• PBIS works well if it is implemented correctly.
• Collaborative culture stuff seems to be so effortless, but it is something they are committed to. This is a project based company.
• How can we do more hands-on math?

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