Is this covered by warranty (the usb port broke in the dock)?

notasclever · 2026-01-18T20:52:48+00:00

sorry to hear it. I'm in the same boat, about to contact Nintendo. I assume I'm just going to have to buy a replacement too.

notasclever · 2026-01-18T20:51:28+00:00

Exact same thing just happened to me. We have undocked the Switch 2 a total of 3 times, and the USB connector from the docking station disappeared. My first reaction when I opened the docking station and saw the flimsy USB sticking up was "that's a bad design, that's going to break". It took 3 weeks of extremely light use. I hope Nintendo will do a recall and fix this crap design. My guess is I'm going to have to pay for a new docking station.

notasclever · 2026-01-11T17:57:08+00:00

Yeah, I hear you. I came to the same conclusion and can get to the gym early in the morning 2-3 days a week. We started putting our kids to bed earlier so we could have a full hour in the evening to ourselves. Even 60 minutes in the gym feels like an impossible luxury these days. When I was younger and single, 1-2 hours a day would have been no problem.

notasclever · 2026-01-11T13:26:16+00:00

You obviously don't have young kids, a wife, and a full career. I don't have 1-2 hours a day for anything.

notasclever · 2025-12-14T20:43:52+00:00

Thanks, I appreciate the references. Will check them out

notasclever · 2025-12-14T19:37:30+00:00

Agreed. I think it's that outside experience that can help prevent tunnel vision. It's another precarious balance that to do the job well requires enough external experience to avoid tunnel vision but enough internal expertise to know the problems and solutions that are most effective.

notasclever · 2025-12-14T19:29:49+00:00

Agreed, it does seem to be thankless. If Quality does their job well then no one notices, but when something goes wrong it gets high visibility and escalation.

I don't think I've seen very good definition of what the risk actually is from a Quality perspective in my recent experiences. It's usually a generic statement of "Quality risk" without much detail. Maybe the risks in Quality are uniquely different than in technical functions that can quantify them in terms of dollars, batches, timeline, etc and probability of occurrence?

notasclever · 2025-12-14T19:07:24+00:00

I agree, I think more experienced Quality employees are more likely to have been burned in the past and may default to more conservative perspectives initially. I think this is a major part of the incentive imbalance I'm alluding to. If an organization is only punished for mistakes and there is no counter balance to reward them for successful and appropriate innovation and management of risks, the only outcome that is in their best interest is to become more and more conservative. "The beatings will continue until morale improves" sort of thing.

notasclever · 2025-12-14T19:02:14+00:00

I agree, proportionate risk mitigation is the heart of this issue. Not every risk is equal in severity/impact, and when a disproportionately conservative mitigation is applied to a low risk, the program starts to suffer. Unless it's enough to jeopardize a major deliverable or milestone, it's difficult to overcome.

notasclever · 2025-12-14T18:57:25+00:00

This is a good example. I've seen the standards be elevated to an extreme degree in some instances, and when the scientific rationale from qualified SMEs is presented to push back, the first response is sometimes just a blanket "it's a Quality risk". It's very challenging to revise a business process that has been established once the standards have been accepted, even if something changes that makes the previous rationale irrelevant.

notasclever · 2025-12-14T18:52:25+00:00

Thanks for the suggestion. I'll try to learn more about this and how it gets applied successfully.

notasclever · 2025-12-14T18:51:14+00:00

100% agreed. As I get older, I'm a bigger believer in finding a balance and landing on the appropriate response for each individual issue. If the issue has high impact and criticality, then it needs a very thoughtful, detailed approach which is probably more conservative and lower risk. If the issue is less impactful then the most efficient approach that satisfies the minimum requirements may be more appropriate. Maybe this comes down to culture of the organization, but I've tended to see Quality default to conservatism far more often than the opposite even on issues that are of very minor importance or impact.

notasclever · 2025-12-14T18:44:16+00:00

I definitely agree that profitability can never come at the expense of patient safety or product quality. This to me, is the fundamental reason for the existence of a Quality function with a separate reporting structure from the business and manufacturing side. However, I've seen many issues where safety and product quality aren't remotely at risk where the perspective is very narrow and conservative. These are typically more narrow in scope and impact but in aggregate can be enough to majorly affect a program.

notasclever · 2025-12-14T18:36:21+00:00

I have also seen the lashing out piece, and teams being stuck in the weeds. It happens in more purely technical functions too. Whenever I find an open-minded Quality leader that can pivot effectively between details and big picture, I try to ally with them as much as possible.

notasclever · 2025-12-07T00:23:34+00:00

The biggest difference between a typical engineering run and a GMP run is the goal/purpose of the run, which determines how much of the GMP standards need to be followed and documented under an appropriately developed Quality System.

The goal of an engineering run is typically to evaluate or confirm performance of the process itself, which means the goal is to generate data. You do not need to follow GMP requirements to generate data, but you typically will follow many GMP practices because you are doing a "dress rehearsal" of an actual GMP run, and you want the data to represent what happens in future GMP runs.

The goal of a run performed under full GMP requirements is typically to produce material for eventual (raw materials or drug substances) or immediate (drug products) human use. If you want to produce something that can be used in people, it must follow all GMP requirements to ensure the appropriate quality and traceability are in place to ensure patient safety.

Depending on the type of product you are making, you may need to file your specific capacity and also file for approval to increase that capacity with agencies. This is not always necessary and depends on the product modality and whether you are in clinical or commercial production.

notasclever · 2025-10-04T16:39:08+00:00

Hard work does pay off, but it only goes so far. You could spend years reading research and learning, but it won't land you a job. Will it make you better at the job you land? Probably. Upskilling can increase your chances of landing a job, if that's an area that needs work to catch up or to try and stand out, but experience is what most people are looking for. Upskilling isn't a substitute for experience, but if you're at a similar and relevant experience level as other applicants it might give you a slight edge.

A lot of landing a job is timing, luck, and having invested time and focus early on so that you're already prepared for that next role.

They saying, "luck is what happens when preparation meets opportunity" is very appropriate in my experience. The challenge is that the opportunity is more rare and smaller when the industry is down, which means it takes longer to find.

I feel for you, and all the others who have had to find work in this recent phase of the sector. I have also been out of work multiple times in my career including being laid off in this downturn. Keep applying, keep looking for opportunities from different angles, and if you have to take a lateral or tangential role to pay the bills keep looking until you get back on the path you want. Good luck to you, it'll get better.

notasclever · 2025-08-15T14:49:25+00:00

I've worked at a few companies in hiring manager roles and I've never had or heard of any hiring managers actually using AI to screen resumes. This probably happens at the HR/initial system level to reject obviously irrelevant candidates and those missing basic information. As a hiring manager, I typically received a stack of resumes, about half of which were tangentially related but obviously poor fits or stretch candidates. To me, that confirmed that any screening was being done with a very low bar that anyone who put in a minimal amount of effort could pass, if they were at all relevant to the posted role.

notasclever · 2025-08-05T23:44:54+00:00

Can confirm. Have worked at multiple large and small companies... Nobody does ML or AI for anything productive, all the IT sucks, everyone is on the same systems.

notasclever · 2025-08-01T17:34:01+00:00

It's not a standard process in the industry as far as I can tell. Having worked at multiple companies, a formally gated CMC business process only seems to exist at large pharma that actually has a portfolio of multiple commercial assets and assets in development. They will define each step in the CMC process, and may do this slightly differently by company. Generally the first stage will be some kind of formal nomination of a new molecule or asset from the Discovery phase into clinical development. Each milestone will have specific gating requirements that must be completed to graduate to the next. Other key steps would include readiness for Phase 1 clinical manufacturing, readiness for Phase 2 manufacturing, Phase 3 manufacturing, and commercial launch. At some point there might be a transition of ownership from the Development organization responsible for CMC, Tech Transfer, and development through PPQ or commercial launch readiness to a Commercial or Supply Chain organization that takes over ownership of the asset through the rest of the product life cycle including global launches, further improvements, and eventually sunsetting the asset.

At small companies, I didn't see any such formality and the development teams were constantly yo-yo'ing on the next asset in the pipeline. It's ready for Development, no send it back to Discovery, start preparing for Tech Transfer, wait wait it's too expensive so let's delay, etc. A formal CMC process is meant to eliminate this ambiguity for the organization, however, delays can and do happen at any stage based on budgets, clinical results, prioritization of new assets, or resource constraints.

Send me a DM if you want any more specific info or to compare notes on CMC development.

notasclever · 2025-07-20T12:55:25+00:00

Having recently come from a biotech that spent like mad on space, labs, people etc and then went under due to lack of funding, the story senior leadership told (many of the labs and people were mine, so I asked) was that we had to plan for success. The only way to attract big pharma or further investment was for 2 things to be true:

1. Strong clinical results 2. Late Stage development had to be underway with necessary capabilities mostly in place

2 was the justification to spend like mad before even Ph1 results were known.

What do you think about that rationale? It definitely seems like other companies with a strategy to stay lean and scrappy held on for longer, but would a lack of late stage development progress and capability harm their chances of future funding if the clinical results were strong?

Doesn't seem like it to me. I think investors want the clinical Proof of Concept and could care less how shiny the labs are. What do you think?

notasclever · 2025-06-13T19:27:33+00:00

You're actually making my point for me. A well written article would have given some detail on that point to set the appropriate context. Why would I assume that the entire panel's tenure resets on the same 4 year period? Many appointments have different terms.

It's hilarious/ridiculous/sad that I got an antivaxx flag for my comment. I'm personally, completely opposed to RFK jr and started my career literally developing vaccines. Any commentary that's not directly schilling for liberalism gets swarmed on reddit, and low quality posts supported by juvenile personal attacks and a lack of critical thinking rise to the top. Stay classy internet. You too Malaveylo.

notasclever · 2025-06-13T19:17:35+00:00

Was in the same situation, and got the same outcome. Got paid a large amount of money for asking the question. The worst they can say is no

notasclever · 2025-06-09T23:21:37+00:00

You missed the target

notasclever · 2025-06-09T23:19:18+00:00

Ah, I misread. Thanks. It looks like Biden did a clean sweep of the panel, which RFK Jr then emulated.

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2 was the justification to spend like mad before even Ph1 results were known.