Process Development Specialist – Small Molecule API

Process Development Specialist – Small Molecule API Join to apply for the

Process Development Specialist – Small Molecule API

role at

Cpl .

Location:

Swords, Co. Dublin

Contract Type:

Permanent

Note:

This position is

onsite , and

relocation support is provided .

The Opportunity We are seeking a

highly skilled and motivated Process Development Specialist

to join our dynamic CDMO environment.

In this

technical leadership role , you will lead the

development, optimization, and scale-up

of robust, safe, and cost-effective

small molecule API processes

from clinical to commercial manufacturing.

You will collaborate closely with

R&D, Technology Transfer, Quality, SHE, Process Engineering, Manufacturing , and external clients to ensure right-first-time delivery of projects.

Key Responsibilities

Lead end-to-end

API process development

from lab to GMP manufacturing.

Design and execute

experiments

to improve process robustness, yield, purity, and sustainability.

Apply

Quality by Design (QbD)

and statistical tools such as

DoE , risk assessment, and multivariate analysis.

Identify and mitigate potential

scale-up or safety risks , including thermal and exothermic hazards.

Provide

technical leadership

and mentor development chemists.

Author and review

technical and quality documentation .

Support

new project proposals

and contribute to client technical discussions.

Champion and implement

new technologies

(PAT, automation, AI tools, sustainability).

Lead

cost reduction

and

process efficiency

initiatives.

Ensure full compliance with

cGMP, EH&S , and electronic lab notebook systems.

Foster a culture of

safety, collaboration, and technical excellence .

Qualifications

PhD in Organic Chemistry

or closely related field

8–12 years’ experience

in small molecule API process development (CDMO experience preferred).

Key Skills & Attributes

Deep technical expertise in

organic synthesis

and process development.

Strong analytical and problem-solving mindset.

Proven track record in

GMP and regulatory environments .

Excellent communication and collaboration skills with internal and external stakeholders.

Experience mentoring team members and managing client relationships.

Proficiency in

ELNs

and data management systems.

Proactive, innovative, and results-driven attitude.

What We Offer

Excellent opportunities for

career growth and professional development .

Competitive salary

and

annual bonus

linked to company performance.

Private healthcare ,

pension scheme , and

education support programs .

A collaborative, innovation-driven culture where your ideas matter.

Seniority level Not Applicable

Employment type Full-time

Job function Research, Science, and Manufacturing

Industries Pharmaceutical Manufacturing and Chemical Manufacturing

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