Senior Scientist – Oral Solid Dosage Development (Small Molecules)

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

Our client is an international biopharmaceutical organization focused on developing and bringing to market novel treatments for rare and ultra-rare genetic and immunological conditions. The company is patient-driven at its core, pairing strong scientific capability with genuine commercial partnerships to translate research into therapies that reach the people who need them. As the pipeline and manufacturing footprint continue to grow, the organization is looking to add a critical senior scientific hire to its CMC group.

About the Role

In this role, you will serve as the internal expert and Lead on drug product and final product manufacturing for the client's portfolio of small molecule compounds. Responsibilities span leading process development, scale-up, validation and technology transfer, along with shaping packaging approaches for both primary and secondary formats. You will coordinate closely with external manufacturing partners (CMOs) to guide products from early clinical phases through commercial launch, working as part of a broader Chemistry, Manufacturing & Controls function.

Key Responsibilities

• Independently lead advanced development, scale-up, validation, and process transfer studies for small molecule drug products.
• Drive design and implementation of primary and secondary packaging solutions.
• Manage external CMOs for development, manufacturing, and validation of clinical and commercial batches.
• Represent DP/FP expertise within cross-functional CMC teams, aligning strategy with overall development goals.
• Plan, prioritize, and deliver work within timeline and budget.
• Author and present scientific reports, technical documentation, and stakeholder updates.
• Support knowledge transfer and mentor junior scientists.
• Contribute to business development activities by assessing manufacturing implications.
• Own and manage complex deviations, CAPAs, and change controls to timely, compliant resolution.
• Troubleshoot manufacturing challenges with science-driven solutions.
• Stay current on EMA, FDA, and ICH regulatory requirements and industry trends.
• Write and review development reports, validation documentation, and CMC dossier sections (IMPD, IND, NDA/MAA).
• Act as subject matter expert in interactions with regulatory authorities on complex questions.

Your Profile

• You hold a PhD or MSc in a relevant scientific field such as Pharmaceutical Sciences, Chemistry, or Chemical Engineering,
• Upwards of ten years of industry experience in pharma or biotech, at least five of which involve hands‑on work in small molecule drug product development.
• You have a demonstrated history of managing outsourced manufacturing partners across both clinical and commercial-scale production.
• Project management exposure is a plus, and familiarity with other drug modalities beyond small molecules would be an added advantage.
• You bring solid command of cGMP practice and international regulatory frameworks (EMA, FDA, ICH), particular strength in solid oral dosage form development, and strong written and spoken English.

What's on Offer

• A competitive annual salary with a 15% performance bonus, 8.33% holiday allowance, a minimum of 30 vacation days, and an excellent pension plan — within an organization dedicated to advancing treatments for rare disease patients worldwide.