Harsh Thakkar

CEO @ Qualtivate- consultancy helping life sciences to elevate quality management maturity, ensure regulatory compliance, and deploy innovative technology solutions.

In 2022, after working as a consultant for big pharma and having managerial roles in biotech startups, I decided to go all-in on building Qualtivate. 

Qualtivate is a tech-forward consultancy helping early-stage life science companies with QMS, GxP compliance, computer system validation, digital transformation, and data management projects.

Aside from consulting, I love sharing content about quality, consulting, entrepreneurship, and even the occasional meme! My online community has grown like crazy, and the business has too—big thanks to everyone who’s been along for the ride.🙏💙

Why consulting?
Because I get a kick out of building processes and implementing or enhancing systems, working closely with innovative IT and QA leaders. Every new project brings a unique challenge that I find super satisfying to solve for our clients.

My approach to consulting is pretty straightforward. I give my clients three options: 

1) do nothing
2) take my plan and run with it or 
3) bring my team to get it DONE ✅ 

Don’t just take my word, here’s what our clients have to say:

“Qualtivate did a phenomenal job accommodating a last-minute software audit and provided us with a quick audit summary and recommendations.” 
- Project Manager

“Our IT team is going 1000 miles an hour. Glad we have someone like you here to guide them through the compliance checks.” 
- Director of Quality Assurance 

“I appreciate Harsh’s depth of knowledge in computer software assurance and his commitment to quality. He often challenges the status quo and explains his viewpoints in a pragmatic way that is easy to understand.” 
- Sr. Director, Global Compliance

“The automated data extraction app your team built with AI saved 40% of my internal team’s time copy pasting data from Certificate of Analysis (CofA) into our LIMS and other systems.”
- Director, QC and External Quality

“Our client is expecting an FDA inspection soon. When we asked another SaaS company director if they know any QMS consultant, they referred us to you.”
- C Level executive of a SaaS company 

If we sign NDA, I can give you names of above folks.
—-

Oh, and I host the Life Sciences 360 podcast! I get to chat with biotech execs, researchers, and industry experts about their work. It’s all jargon-free and easy to follow. Give it a listen (or watch on YT)—it’s free to subscribe!

—-

For consulting help, message me here or send an email to hthakkar@qualtivate.com

Want to come on the podcast as guest? Or talk about speaking engagements, brand partnerships, ads, or sponsorships? 
Email Nikki at npalmieri@qualtivate.com

CEO and Founder– Qualtivate 

Qualtivate is a quality management and regulatory compliance consulting firm helping life science companies make data-driven decisions throughout their product development lifecycle.

How?
Cultivate insights from your QMS data in hours, not days using our technical expertise in off-the-shelf no-code, automation and AI/ML tools.

Build your phase-appropriate quality management system (QMS) that:

• Provides full transparency of product data, processes, systems, and people. 
• Automates performance monitoring and quality management reviews.
• Embeds compliance within flexible, user-friendly, organically built processes.
• Reduces the organization's quality costs by automating data collection, analysis, trending, and reporting.

To find out more about how we can help, please get in touch with me directly on the details below. 

☏ +1-919-213-8737
✉ hthakkar@qualtivate.com 	
Visit ☛ www.qualtivate.com


I’m a passionate and results-driven biotech search partner, specializing in helping early-stage and growth-stage life sciences companies build the teams they need to hit critical milestones and scale with confidence. With over 10 years of experience in executive search and talent advisory, I thrive in fast-paced, high-stakes environments where the right hire can materially change a company’s trajectory.

I’ve been fortunate to work alongside leaders at biotech and pharmaceutical companies developing therapies in oncology, immunology, neurology, and rare disease. My track record includes 200+ completed searches across R&D, CMC, Tech Ops, Clinical, and G&A functions—supporting organizations from early discovery through IND, clinical development, and commercial readiness. 

What sets me apart is my ability to blend strategic talent planning with a highly hands-on, execution-focused approach. I don’t just fill roles—I partner closely with leadership teams to align hiring decisions with scientific, operational, and business milestones, while advising on org design, compensation, and long-term team buildout. I’m deeply invested in building durable teams with strong retention, chemistry, and mission alignment.

Whether it’s assembling a first-in-class discovery team, scaling CMC and technical operations, or supporting a company through a pivotal inflection point, I’m driven by the challenge of building scalable, sustainable organizations. My goal is always to create measurable impact—accelerating timelines, reducing hiring risk, and helping biotech companies move their science forward with the right people in place.

Jeff Caskey

Are you a scientist (all levels) and open to hearing about future job opportunities in the Maryland/DC region?

At Nexagen Search, one of the main regions we support is the BioHealth Capital Region.

This post is an open invite to send us your recent resume and a confidential signal that you're interested in staying connected about new opportunities in 2026. We don't just place people now, we build networks for future opportunities as companies grow and the ecosystem evolves.

Whether you're starting your industry career or looking for your next leadership role, we want to keep you in mind.

If you're interested, drop us a resume. Confidentiality is guaranteed. We'll keep you informed about relevant opportunities as they arise.

Link: https://lnkd.in/d6kKdT5h

Happy Tuesday!

Open article: Open to New Roles in Maryland: Scientists (All levels) (MD, USA) by app.loxo.co

Open to New Roles in Maryland: Scientists (All levels) (MD, USA)

Want to know the real secret to building a killer R&D team in early-stage biotech?

Build your team like you're drafting a band, not assembling a chess set.

You don't need five lead guitarists.

You need:
- One person who can find a signal in the noise and doesn't freak out when the plan falls apart.
- Someone who actually enjoys troubleshooting reagents at 9pm.
- A scientist who asks questions that annoy everyone but spark actual breakthroughs.
- The quiet optimizer who turns chaos into a real process, and keeps the plates spinning when the rest of the room is all jazz hands.

I want people who can stomach ambiguity, laugh when experiments blow up, and still show up ready to try it again.

That's the real secret sauce.

If your team can't handle the mess, you're building on sand.

So, next time you're hiring for R&D, ask yourself: are you picking bandmates, or just collecting resumes?

Biotech startups often underestimate one of their biggest risks.

A bad leadership hire. 

You hit a milestone, raise a round, get backed by serious investors. Then you scramble for a certain leader. Everyone agrees you need a CTO or a CMC head. So you rush. You fill the role. 

Six months later, it unravels. The new hire can't scale. The team culture buckles. Momentum turns into gridlock. 

Biotech success runs on timing. That means planning for talent as carefully as you plan experiments. 

Here's what works:
- Map your next 18 months. Where do the scientific and business goals shift?
- Identify must-have leadership skills for each phase. Today's head of R&D may not be tomorrow's CSO.
- Start vetting prospects before you need them, not after you're already scrambling.
- Involve boards and investors early. If they're surprised by your talent choices, you waited too long.

Treat hiring like a critical experiment, not an afterthought.

Ignore this, and you'll be stuck fixing mistakes, not scaling science.

If you get this right, your team grows as fast as your ambition.

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Founder | Managing Partner

Principal Recruitment Consultant

Recruiting Team Lead

Scientific Recruiter

Intern

Founder, Managing Partner @ Nexagen Search 

Talent Acquisition Consultant

In a crowded candidate pool, small things make a difference.

Thank you emails after interviews are almost extinct. Why? I have no idea.

It used to be automatic. Now, it's rare.

From where I sit, working between candidates and hiring managers, I know it still matters. Not every time. But when things are close, it can move the needle.

Example from 2025.

Senior Director search. Two final candidates. Both ticked every box.

Candidate A? No follow-up.

Candidate B? Sent a thank you email, plus a simple 90-day plan outlining what they'd tackle in the role.

That was it. The follow-up became the tiebreaker.

If you want the edge, don't overthink it. Be the candidate who follows through.

How do you answer the desired compensation question on job applications? 

This question trips up a lot of people and I'm hearing it from job seekers more often than ever. 

This question has long existed on job applications, but there are a few new factors at work here. 

First, 14 states and DC now have laws requiring companies to include compensation about salary ranges. By 2026, more will follow. 

This means you might see compensation ranges posted, but in many cases the range is really wide (eg. 95k -180k). What number should you pick? 

Second, AI tools are now screening applicants and assessing what bucket your application goes in, yes or no. 

If you give a number too low, you leave money on the table or in some cases even seem underqualified. 

Too high, and you might get filtered out. 

The truth is that you don't know how these systems are set up so trying to "beat the system" is futile in many cases. 

Here's what I tell people: 

- Before applying to any jobs, map out your desired compensation. 
- Do your homework. Check industry resources. Talk to colleagues in similar roles. Ask a recruiter. 
- In most cases, companies will hire near the middle of the range. If you list a compensation at the top of the range, you may get screened out (dumb, I know). Focus your efforts on roles where the middle of the range lines up with your desired compensation. 
- If you get the interview, ask this question near the end of the interview: "I noticed in the job posting that the salary range is XX- XX. That aligns with my expectations, but I was curious how COMPANY determines compensation within that range?"

"For one medicine to get through discovery, pre-clinical testing and then be successful in phase I, phase II and phase III clinical trials requires an average of 7,000,874 hours of work, 6,587 experiments and 423 researchers" 

I stumbled across this article this morning from 2022 that was written by Paulo Fontoura. 

For years, I've seen statistics highlighting the odds of taking a single medicine all the way through clinical trials (~10%), but it typically relates only to medicines that make it to phase I.  

7 million hours of work. Think about that. 😳 

But here's the ROI. How many hours of human life do these medicines give back to humanity? 

Every hour in the lab, writing reports, or in a meeting is a gamble on more life, less suffering. But it's a gamble we must keep taking because it's the future of humanity that we are betting on. 

Keep rolling the dice!

Open article: Professional success and personal highlight: what it means to bring a medicine to the people that need it by Paulo Fontoura • 4 min read

Professional success and personal highlight: what it means to bring a medicine to the people that need it

So proud of Melissa Lawrence for the launch of her book. I’m getting my copy and highly recommend!

Founder, Managing Partner @ Nexagen Search

Helping women in pharma & biotech make the right career decisions — with clarity, strategy, and self-trust | 🎙️Your Worthy Career | Former Pharma Talent Leader turned Founder and Coach

You can be successful on paper…
and still feel uncertain about your next move.

That’s exactly why I wrote Your Worthy Career: A Science-Backed Method to Build a Meaningful Career in Pharma and Biotech.

It’s officially available today on Amazon at https://a.co/d/054VfjRO

This book gives you a clear, science-backed method to build a meaningful career in Pharma and Biotech — without burnout, sacrificing your values, or settling for "good enough".

Today only the book is 50% off ($18.50).

Launch-week readers also receive access to a limited-time companion workbook (via QR code inside the book) with every exercise in fillable format.

This book is influenced by:
🧬 Years inside the industry
🧠 Organizational psychology
😍  Five years coaching women full-time

If you’re ready for a proven method to grow your career as a woman in industry  — this is for you.

It's a dream come true to get this book in your hands - and I can't wait to hear how it helps.

#womeninpharma #pharmacareers #womeninbio #womeninscience #careerdevelopment

Most biotech companies track time to hire.
But almost no one tracks what really matters: Time utilized to hire.

Time to hire is just calendar days.
Time utilized is the total internal hours your team spends.
For early-stage biotech, that number is dangerous.

Let's say you're hiring a Scientist for your group.

To fill one role:
- The hiring manager spends 20 hours 
- The CSO spends 8 hours interviewing 
- Four scientists spend 2 hours each interviewing
- Leadership joins two debrief meetings

That easily adds up to 40+ internal hours per hire.

Now multiply that by 8 to 10 hires a year.
That's 320 to 400 hours lost to recruiting.

During that time, your team could be:
- Developing assays
- Planning IND strategies
- Having partner conversations
- Engaging investors
- Preparing for clinical milestones

All gone.

Early-stage biotech isn't held back by ideas.
It's held back by time and focus.

When I work with a new company, I don't just audit how long it takes to hire.
I ask:

- How many interview rounds exist?
- How many people are involved at each stage?
- Who owns the decision?
- Where are evaluations being duplicated?

The goal isn't to cut corners.
It's to protect your scientific and executive time.

A good hiring process in a 20–50 person biotech should be:
- Clear intake process
- Defined interview roles
- Structured evaluation
- One decisive debrief

Nothing more.
No endless calendar invites.

Hiring matters.
But protecting time is survival.

If you're heading toward IND, Phase I, or a key partnership,
your hiring process should accelerate your milestones, not slow them.

Have you ever calculated how many internal hours your team spends per role?

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Harsh Thakkar

Jeff Caskey

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