The Big Pharma Habits You Have to Unlearn in a Startup, with Dawn Lundin

Twenty years at Merck, then a leap into academia and psychedelic medicine - here is how Dawn Lundin built a quality career on instinct.

Dawn Lundin on the big pharma habits you have to unlearn in a startup.

In today's episode I was joined by Dawn Lundin, founder of her own quality consultancy and a fractional Head of Quality across biotech and psychedelic-medicine companies. I really wanted to speak to Dawn because her path is nothing like the typical quality leader's. She didn't stay inside big pharma and climb one ladder. She spent twenty years at Merck, then walked into academia, then into one of the most stigmatised fields in medicine, and she made each move work.

Dawn started as a bench chemist and grew through GLP, clinical packaging, GCP auditing and pharmacovigilance, eventually heading up issues management and co-authoring the first quality manual for Merck's research division. Then, on the morning of her twentieth anniversary, she resigned. She moved to the University of Pennsylvania to build fit for purpose quality systems for both sponsor and site research, a system still in use today. From there she stepped into psychedelic medicine for mental health, a move driven as much by personal loss as by professional curiosity.

What runs through Dawn's whole story is a refusal to lead by importing an old playbook. In a smaller, faster environment she learned to do quality with far less, to put relationships before procedures, and to build trust before she changed a single thing. Her line for it has stuck with me: she did quality "one cup of coffee at a time."

We talk about the following:

• Why she left twenty years at Merck on the exact morning of her anniversary
• The big pharma habits leaders have to unlearn in academia and startups
• How to build a fit for purpose quality system with a fraction of the resources
• Why relationships, not procedures, carry a quality programme in a small organisation
• The personal story that drew her into psychedelic medicine and mental health

Dawn Lundin is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments. If you are a quality professional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you. Thank you Dawn for sharing your incredible journey. Hope everyone enjoys the show.

WHO THIS EPISODE IS FOR

• Quality leaders moving from big pharma into a startup, scale-up or academia
• Hiring managers building a first quality team and weighing up big pharma candidates
• Early-stage biotech founders who need fit for purpose quality without the overhead
• Quality professionals weighing a bold or unconventional career move
• Anyone drawn to how mental health and psychedelic medicine are being built responsibly

Timestamps:

(00:00) - Introduction to Dawn Lundin

(01:15) - Dawn's Journey into Science and Quality

(05:05) - Career Growth at Merck

(11:16) - Transitioning from Big Pharma to Academia

(17:34) - Navigating Startup Challenges

(22:54) - Current Consultancy and Future Aspirations