Senior Scientist - Solid Oral Dosage Development Lead

QTC Recruitment; Zuid-Holland; On-site; EUR 150,000 - 190,000; Full time

Benefits offered by this job

15% performance bonus

8.33% holiday allowance

30 vacation days

Pension plan

Job summary

QTC Recruitment seeks a senior CMC Lead to direct drug product development for a portfolio of small molecule therapies. You will lead process development, scale-up, validation, and tech transfer, while coordinating with CMOs for clinical and commercial batches.

You will ensure compliance with cGMP and EMA/FDA/ICH standards, shape packaging strategies, and contribute to regulatory submissions. Strong leadership and English proficiency are essential.

Qualifications

• PhD or MSc in pharmaceutical sciences, chemistry, or chemical engineering.
• Over 10 years of industry experience in pharma/biotech with 5+ years in small molecule development.
• Experience managing outsourced CMOs for clinical and commercial production.
• Solid command of cGMP and EMA/FDA/ICH guidelines.
• Excellent written and spoken English.

Responsibilities

• Independently lead process development, scale-up, validation and tech transfer for small molecule drug products.
• Drive primary and secondary packaging design solutions.
• Manage external CMOs for development, manufacturing and validation across clinical and commercial batches.
• Represent DP/FP expertise within cross-functional CMC teams and align strategy with development goals.
• Author and present scientific reports and regulatory documentation.
• Mentor junior scientists and support knowledge transfer.
• Stay current on EMA, FDA and ICH regulatory requirements and trends.
• Write and review development reports and CMC dossier sections (IMPD/IND/NDA/MAA).

Skills

cGMP

Regulatory knowledge

Outsourced manufacturing

Project management

Education

PhD in Pharmaceutical Sciences

MSc in Chemical Engineering

Job description

QTC Recruitment seeks a senior CMC Lead to direct drug product development for a portfolio of small molecule therapies. You will lead process development, scale-up, validation, and tech transfer, while coordinating with CMOs for clinical and commercial batches.

You will ensure compliance with cGMP and EMA/FDA/ICH standards, shape packaging strategies, and contribute to regulatory submissions. Strong leadership and English proficiency are essential.