Biotech Employees in Short Supply, a rant

The Boston Globe reported this past weekend “In the region’s booming biotech industry, workers are in short supply“, which is both good news and bad for me.

Good news is that my career prospects are always good.

Bad news is that I am hiring and building teams within quality.

“also affect the quality of work as key positions become harder to fill and lower-level workers jump from company to company in search of a better compensation package.“

For compensation package, read total cash. Sure there can be a difference on how good other benefits can be, but they all kind of get blurred together and I don’t think I noticed any difference between benefits packages until I went to a small startup, and I definitely knew what I was getting into there. The article later goes on to say some biotech is starting to offer some of the benefits seen in more computer-driven fields, but maybe folks should pay attention to how that is usually a trad to entice people into longer hours.

Notice the emphasis on lower level workers. Read that for “We don’t really offer good development programs and the only way to get promoted in this title-obsessed field is go to another company.”

According to the latest report from industry association MassBio, nearly 85,000 people work in the state’s life sciences sector, up 55 percent from 2008.

And sometimes you feel like you know all 85k, and have worked with most of them.

“You can’t walk two blocks around Kendall Square without receiving a job offer,” said Jeanne Gray, chief people officer at Relay Therapeutics in Cambridge, only half-kiddingly. “I get the sense that a lot of candidates know the market is hot.”

And she only made it 2 blocks because of the pandemic. Seriously, this joke has existed for over a decade.

About 16.5 percent of life sciences employees in Massachusetts voluntarily quit their jobs last year

Wouldn’t you if you keep getting better offers, often unsolicited from other companies and your current company gave you a measly 2-4% raise? Companies want folks to stay, start giving real raises commensurate with the market increase. As a manager, looking someone in the eyes (or vaguely at their eyes because we are both on camera) and telling the best the company can do is a 3% raise is pretty damn problematic. Especially if the employee knows how to read a SEC filing (if your company is public make sure you read these at every update).

There’s also a sense that employees are easily swayed by “title inflation,” a phenomenon that occurs when people climb the corporate ladder faster by bouncing around.

This is a problem in a field where title is everything. Where people where their MDs and PhDs as holy vestments. Where title is tied to autonomy and with ability to influence. This is a complex systematic problem, and few companies are even thinking of how to fix it, and probably can’t because the problem starts at the C-suite. No the problem starts with the regulators. See it’s complex, it starts in a lot of places.

I’m doing my little experiment here, I went to a company started by two incredibly earnest guys who had just graduated from Brown. Is everything perfect? Never is. But the experiment itself is fascinating to participate in.

“the talent pool has not matured enough to fill key areas from the C-suite and clinical development, all the way through to the commercial launch of products.“

Yes, expertise matters. However, we prize years-in-seat more than we should sometimes, and we do not spend enough time building talent. And let’s be honest, that leads to a lot of director levels who do not know how to actually do the thing they are supposed to do beyond the last time they did it.

This is definitely a ranty post.

Visual Management

In the organizational world Visual Management is a management system that attempts to improve organizational performance through connecting and aligning organizational vision, core values, goals and culture with other management systems, work processes, workplace elements, and stakeholders, by means of stimuli, which directly address one or more of the five human senses (sight, hearing, feeling, smell and taste). These stimuli communicate quality information (necessary, relevant, correct, immediate, easy to-understand and stimulating), which helps people make sense of the organizational context at a glance by merely looking around. It is a management approach that utilizes either one or more of information giving, signaling, limiting or guaranteeing (mistake-proofing/ poka-yoke) visual devices to communicate with “doers”, so that places become self-explanatory, self-ordering, self-regulating and self-improving.

Function	Definition	Replaces the Practice of
Transparency	The ability of a process (or its parts) to communicate with people through organizational and physical means, measurements, and public display of information Transparency stimulates people to move outside the confines of particular job responsibilities and to see the larger scale of their work	Information held in people‟s minds and on the shelves.
Discipline	Making a habit of properly maintaining correct procedures by transforming the abstract concept of discipline into directly observable concrete practices Address the six basic questions (the what, the where, the who, the how, the how many and the when)	Warning, scolding, inflicting punishments, dismissing etc.
Continuous Improvement	Focused and sustained incremental innovation Makes organizational learning visual with high ability to respond to people’s ideas	Static organizations or big improvement leaps through considerable investment.
Job Facilitation	Conscious attempt to physically and/or mentally ease people’s efforts on routine, already known tasks, by offering various visual aids	Expecting people to perform well at their jobs without providing them any aids.
On-the-Job Training	Learning from experience or integrating working with learning.	Conventional training practices or offering no training.
Creating Shared Ownership	A feeling of possessiveness and being psychologically tied to the objectives	Management dictation for change efforts, vision and culture creation.
Management by Facts	Use of facts and data based on statistics	Management by subjective judgement or vague terms.
Simplification	Constant efforts on monitoring, processing, visualizing and distributing system wide information for individuals and teams	Expecting people to monitor, process and understand the complex system wide information on their own.
Unification	Partly removing the boundaries and creating empathy within an organization through effective information sharing	Fragmentation or “this is not my job” behavior

The functions of Visual Management

CVs and JDs and Training Plans

In the post “HR and Quality, joined at the hip” I covered some of the regulations that set the expectations in the pharmaceutical and medical device industries that employees have the appropriate education, experience and training to do their jobs. What is often called the personnel qualification triangle.

A job description is a written document that outlines the duties, responsibilities, contributions, behaviors, outcomes and required qualifications for a specific job in an organization. A good job description is a specification that results from a detailed job analysis. It is used in hiring and performance evaluation. It is also the starting point for determining a good GxP training plan.

In order to providing the specific knowledge, skills, abilities and behaviors that need to be addressed for each employee, the job description needs to specifically call out the roles in the processes an employee will play. Instead of providing broad statements like “participate in CAPAs” or “Manufacture product” it should be more specific such as “create and project manage CAPAs” or “Perform visual inspection.”

I challenge everyone to think broadly about the job description as a tool to drive excellence. Utilized throughout the life of employment, a job description is a powerful tool that can aid managers. Managers have a road map that can help them with their duties of planning, leading, organizing, controlling and staffing. With a road map, the complexities of the organization become easier.

The curricula vitae provides evidence that the employee is fit-for-purpose to the job description. The curricula vitae shows education and experience that demonstrates the possession of knowledge, skills, abilities and behaviors.

The training plan then lays out what the employee needs to bit fit-for-use, to be able to do all the roles in the job description. It includes all the process and role specific training, as well as filling in any gaps that might exist on the curricula vitae.

The Personnel Qualification Triangle of Education, Experience and Training

It is important to note that this may not be a fine equilateral triangle. Experience, for example, can often, but not always make up for education.

Failure Points in the Personnel Qualification Triangle

Position and experience descriptions on CVs do not match the corresponding job description. This red flag stems from a lack of coordination between the curricula vitae and job description, which can be particularly concerning when an employee has a job description that requires very specific technical knowledge or oversees other seemingly unrelated areas that their experience would indicate.
Employee positions current position is not included in curricula vitae. The curricula vitae should always include the current position. While not a deal breaker, this is perhaps the easiest way to see large gaps in the cv, especially if the employee moves around or up in the same organization.
Curricula vitae do not reflect the level of experience expected given the employee’s job title.
The roles and responsibilities documented in in the job descriptions do not correspond with those included in SOPs. A reviewer should be able to go from a process to anyone engaged in the process and be able to see the work the individual does reflected.
Job titles match. Curricula vitae, job descriptions and what an individual is listed as on an organizational chart need to all match. I usually go as far to check someone’s business card before they go into meet with an inspector or external auditor.

New Job, What’s the Approach?

On Monday (September 9th) I start as Head of Digital Quality at Brammer Bio, a division of Thermo Fisher Scientific. The symbolism of starting a new job in the fall in the United States, stands out to me.

I’ve been asked “Just what is digital quality?” To which the easy answer was, “What I do, but in the title.” It is important to expand on that definition here, because this is core to the concept of Quality 4.0.

On one level, adding the word digital in front of anything is kind of a buzz term. It is sort of the ‘i’ of decades past. Yep, head of iQuality, that means pretty much nothing.

There has been a ton written about just what digital is, and I am firmly rooted in the idea that digital should be seen less as a thing and more a way of doing things. Being digital requires being open to reexamining the entire way of doing quality, and that is exciting.

It is also not csv. Computer system verification/validation is a tool, but not an ends in itself. While I will always have one foot firmly in this skillset, I consider myself more a customer and an advocate here. Same goes for IT. IT provides services I make sue of. I’m a major stakeholder to IT, and hopefully an influencer, but I don’t do IT –fellow traveller, most definitely.

Nor is it data integrity, which is an objective or requirement to be met.

Being digital means being closely attuned to how quality, and the use of quality processes and tools, is evolving in the broadest sense. That means understanding how behaviors and expectations are developing inside the organization. It means being saavy to regulator and other stakeholder expectations as well as trends outside the pharmaceutical industry.

Yes it is about bringing in new tools. It is also recogning that the pharmaceutical industry has spent the last few decades building IT capability (ERPs and PAT and QMS and so much more) so a big part of the mission is rethinking how to use these and develop new capabilities to design and deliver the best possible quality experience, across all parts of the business. It is about implementing a cyclical dynamic where processes and capabilities are constantly evolving based on inputs from users and stakeholders, fostering ongoing use.

There is an interconnected set of three core capabilities that I think is crucial to this type of role:

Proactive decision making. Relevance is the currency of the digital age. This requires making decisions, based on intelligence, that deliver content and experiences that are personalized and relevant.

Contextual interactivity. Analyzing what is going on, and will go on, and bringing the right tools and decision-making to the job.

Journey-focused innovation. Quality should give permission and encourage the organization to innovate, expanding uses and deepening capabilities.

Being digital is about using data to make better and faster decisions, devolving decision making to smaller teams, and developing much more iterative and rapid ways of doing things. Thinking in this way shouldn’t be limited to just a handful of functions. It should incorporate a broad swath of how companies operate, including creatively partnering with external companies to extend necessary capabilities. A digital mind-set institutionalizes cross-functional collaboration, flattens hierarchies, and builds environments to encourage the generation of new ideas. Incentives and metrics are developed to support such decision-making agility.

So there’s my mini-manifesto of the journey I’m looking to continue on Monday, at Brammer.

Together with my ongoing activities in the Team and Workplace Excellence Forum of the ASQ, this job is really about what is most important to me: bringing great tools to the right teams to make the right decisions to ensure patient quality.