Manager, Senior Manager – Scientist CMC Analytical Development

Job not on LinkedIn

🔥 0 minutes ago

🇧🇪 Belgium – Remote

⏰ Full Time

🟠 Senior

👔 Manager

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Follow up on execution of the agreed commercial supply plan for outsourced QC testing with CMC commercial and Global supply teams • Receive external CoA and CoC documents and author internal specification documents for bulk drug substance and drug product • Follow up on change controls, deviations, and OOS investigations related to QC activities at external vendors • Support OOE/OOT release and stability investigations, including root-cause investigations and impact assessments • Participate in argenx investigation teams during interactions with external CMOs, providing expert QC input • Monitor stock levels and distribution of critical reagents and reference standards across QC laboratories • Follow up on shipments and support timely replenishment of critical reagents in accordance with regulatory submissions • Follow reference-standard trending and stability programs and author retest-date statements • Maintain the complete product-quality data repository using control charts for analytical critical quality attributes • Follow up on annual stability trending within the approved shelf life • Follow up on analytical-method lifecycle activities, transfers, protocols, reports, and performance trending across QC sites • Contribute to technical and strategic CMC discussions and review CMC Module 3 sections supporting global submission plans

🎯 Requirements

• Master in chemistry, pharmaceutical sciences, bio-engineering, or another discipline within pharmaceutical/biotechnology sciences • Strong technical expertise in biological drug substance and drug product manufacturing • Experience with analytical method development and validation • Experience with process validation • Good understanding of statistics • Fluent in English, written and spoken • Thorough knowledge and experience with GMP • In-depth knowledge of ICH and GMP regulations • Ability to work independently within the assigned field and support others • Ability to keep abreast of relevant scientific and technical developments • Ability to work in detail while maintaining the overall project goal • Strong technical expertise combined with project management skills • Ability to communicate effectively with internal and external stakeholders • Flexible, quality-conscious, well-organized attitude • Ability to operate in a dynamic, fast-growing biotech environment with challenging timelines • Team player able to build effective relationships with internal and external stakeholders

🏖️ Benefits

• Reasonable accommodation for individuals with disabilities • Benefits and privileges of employment • Occasional domestic and international travel opportunities