Sharper decisions through stronger collaboration.
Senior fractional CMC and Technical Operations leadership for biotech and pharma programmes, from CDMO selection and technology transfer through GMP scale up and integrated external partner delivery.
CDMO and partner selection built around your programme, priorities and operating model.
Development knowledge transferred clearly into manufacturing and scale up.
Governance that turns technical priorities into accountable delivery.
Senior Technical Operations leadership, scaled to programme needs.
Devine Edge Strategy provides fractional CMC and Technical Operations leadership to biotech and pharmaceutical organisations navigating outsourced development, technology transfer, GMP scale-up and external manufacturing.
Founded by Dr Lynda Devine, the consultancy draws on more than 15 years of pharmaceutical industry experience across sponsor and CDMO environments, supported by a strong scientific foundation and advanced business education. Lynda holds a PhD in Biochemistry and is completing the final dissertation for the AMBA-accredited MBA at Queen's Business School.
This combination brings a practical understanding of partner expectations, delivery challenges and the points at which programmes can lose clarity or momentum.
Support is provided through fractional leadership, defined project delivery or targeted input at critical programme stages, connecting technical strategy, partner performance and accountable execution.
Senior pharmaceutical operations leader with more than 15 years' experience across CMC strategy, outsourced manufacturing, technology transfer, GMP scale-up, supply continuity and external partner governance.
First-Class BSc (Hons), Biochemistry
PhD, Biochemistry
MBA Candidate, Queen's Business School
Based in Northern Ireland.
Supporting programmes internationally.
- Senior CMC and Technical Operations leadership
- Sponsor and CDMO experience
- CDMO selection and partnership design
- Technology transfer and GMP scale-up direction
- Integrated external partner oversight
- Governance, risk management and regulatory readiness
Collaborative leadership. Clear accountability. Practical delivery.
Devine Edge Strategy works alongside internal teams and external partners to establish shared priorities, clear interfaces and realistic delivery plans.
The approach is collaborative but appropriately challenging, helping organisations identify risks early, make informed decisions and build fit-for-purpose operating structures without expanding permanent teams too soon.
Experienced direction at critical programme stages.
Connecting internal teams, CDMOs, laboratories and specialists around one plan.
Turning technical priorities into clear decisions, ownership and action.
Need experienced Technical Operations leadership without building the full organisation too early?
Discuss your programmeCollaboration needs structure, not just good intentions.
We work alongside internal teams and external partners, providing fractional leadership or focused programme support where experienced Technical Operations judgement can strengthen decisions and delivery.
Align priorities, capabilities and ways of working around what your programme needs to succeed.
Test options, expose delivery risks and surface issues that may otherwise be overlooked.
Establish clear decision rights, accountability and an operating cadence from day one.
Six critical points in programme delivery
Six weeks. Six moments where technical judgement, alignment and collaboration shape programme success.
Each article is published first on LinkedIn and unlocked here on the day it goes live. 2 of 6 Published.
Choosing a CDMO means choosing how your programme will operate.
Technical capability gets a partner shortlisted. Partnership fit determines how effectively the work will be delivered.
A transfer package cannot replace shared understanding.
Make development knowledge visible, challenge assumptions and align both teams before scale up.
If every meeting is an escalation, the partnership model needs attention.
Clear ownership, timely decisions and active collaboration turn meetings into coordinated action.
A booked GMP slot is not proof of programme readiness.
Process, equipment, methods, materials, documentation and supporting evidence need to be ready together.
External partners deliver best when they operate as one integrated network.
Integrate CDMOs, testing labs and specialist contributors around shared priorities, clear interfaces and one coordinated plan.
Senior Technical Operations leadership, scaled to programme needs.
Add experienced direction and coordination without building the full organisation too early.
Let's talk about the next inflection point in your programme.
A 30 minute conversation to understand where you are and where senior technical operations judgement could change the trajectory.
info@devineedge.co.uk