Job Description

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

We are seeking a dedicated CQ Manager Drug Linker
to lead the commissioning and qualification of a specialized chemical synthesis and conjugation facility. This role is critical in ensuring that all systems used in linker synthesis and conjugation processes comply with GMP standards and regulatory expectations. You will oversee complex chemical and bioconjugation equipment, coordinate with EHS and Engineering teams on containment and safety requirements, and ensure seamless integration with downstream processes. This is a highly visible role where your expertise ensures safe, compliant, and efficient manufacturing of high-potency drug substances.

Key Responsibilities

• Lead CQV activities for chemical synthesis equipment, conjugation reactors, chromatography systems, solvent handling systems, and lab-scale GMP equipment.
• Develop and execute CQ deliverables: URS, risk assessments, IQ/OQ/PQ, commissioning documentation.
• Ensure compliance to GMP and safety guidelines for highly potent materials.
• Coordinate with EHS on engineering controls, containment, and facility flow.
• Work closely with Process Chemistry, QA, EHS, Engineering, and external vendors.
• Maintain audit-ready documentation for regulatory inspections.

Required Qualifications

• Degree in Chemical Engineering, Chemistry, or related discipline.
• 10+ years CQV experience in chemical synthesis, conjugation, or ADC environments preferred.
• Knowledge of containment requirements, solvent-based systems, and GMP requirements.
• Strong technical understanding of linker synthesis and conjugation processes is a plus.

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.