A Day in the Life: Manufacturing/Operations Manager, Biotech Company

8:00 a.m.: Check in with people in the lab; review tasks for the day to understand what issues are on the table. Typical tasks include:

• What experiments are running (e.g., effect of cell number density)
• Possible presence of cell contamination
• Adequacy of supplies
• Alignment of schedules across cross-functional tasks (e.g., biochemical analyses conducted by other departments)

9:00 a.m.: Have a weekly two-hour meeting to review general project status. We go over:

• Whether the experiments we ran gave the results expected? (e.g., what was the effect of cell temperature?
• Depending on results, we hold discussions with other departments to develop methods needed to complete our experiments (e.g., flow cytometry)
• Determine if we are on track to meet the timetable set by program management. Otherwise, I do data analysis using Excel or statistical analysis of data generated by the group.

11:00 a.m.: Meet with one or both senior direct reports (PhDs) to review the progress of their research, which involves:

• Developing new immunomagnetic separation schemes to harvest desirable kinds of immune cells
• Modifying and optimizing a procedure for encouraging pancreatic stem cells to grow
• Developing assays to estimate degree of cellular differentiation

12:00 p.m.: Check in with BS/MS direct reports and redirect resources, as needed. This requires that I assign specific laboratory tasks to different people based on overall work load and skill sets [e.g., who is going to do cell culture, HPLC (high pressure liquid chromatography) analysis, or who is going to stock the lab].

1:00 p.m.: Meet with program management or IT to discuss ongoing data programs. This requires that I determine where we have to support other projects for different departments or different directors as well as review ongoing work to with IT to establish a lab information management (LIMs) system.

2:00 p.m.: Attend a cross-functional meeting with representatives of other departments to coordinate scheduling and resource allocation of the group, ensure that the work load was properly staffed, and that work moved from one department to another smoothly (e.g., flow cytometry sample number, time of delivery, and overall through-put).

3:00 p.m.: Meet with my entire group for presentation of data, general administrative issues, announcements, and goal-sharing among direct reports. Agenda topics include:

• New hires, procedures, or upcoming meetings
• Handout summaries of recent results (including graphs, charts, and bullet points)
• Review of experimental results, including cell growth curves, cell characterizations, and inventory levels of biological materials used in cell research

4:00 p.m.: Catch up on email, approve orders, do paperwork, check inventory, talk with purchasing or quality about ongoing issues, including talking about quality issues, tests out of specifications, new SOPs or changes in SOPs

5:00 p.m.: Meet with clinical trials staff to discuss timelines and overall preparedness for clinical trials (e.g., did we have the cells to treat the patients?)

6:00 p.m.: Commute home

8:00 p.m.: Read journal articles and keep up with literature (e.g., Experimental Hematology, Blood) Prepare for presentations either to senior management or general group (e.g., data review, results of current experiments, plans for future experiments)

Process Development Uppers and Downers

Uppers

I like seeing the results of scaling up - being able to make quantities needed to do clinical trials. I like to understand what can scale directly and to solve the challenges of what cannot be scaled. It's like having a favorite chocolate cake recipe that you make for 6 but now you need to make it for 1,000. I find out what ingredients have to be substituted, what containers are needed to handle the larger-size batches and what type of oven gives the best results.

Downers

I get frustrated when the troubleshooting doesn't work, when we have trouble figuring out what we need to do differently. Also, communication with senior management to meet deadlines can be challenging and managing expectations about what can be done becomes important. Many frustrations are things that have nothing to do with science.