Analytical Lead QC – Protein Analytics / Chemical Analytics (f/m/d)

Celonic Group; Heidelberg; Sur place; EUR 110 000 - 160 000; Plein temps

Résumé du poste

Celonic Group in Heidelberg, Germany, seeks an Analytical Lead QC Protein Analytics / Chemical Analytics (f/m/d) to own analytical activities, ensuring high scientific standards, quality, and on-time delivery. You will lead analytical efforts across optimization, transfer, validation, and troubleshooting with strong autonomy.

You will report to the Team Manager QC Chemical Analytics and act as a technical leader without direct people management, collaborating with cross-functional teams and

Qualifications

• MSc, PhD, or equivalent degree in Biology, Biotechnology, Chemistry, Chemical Engineering, or related field.
• 8+ years of relevant experience in pharma/biotech/CDMO analytics.
• Strong experience in analytical development, transfer, validation, and cGMP activities.
• Experience with analytical methods lifecycle, validation principles, ICH/Pharmacopeia guidelines.
• Ability to lead complex analytical activities and coordinate cross-functional work.
• Excellent planning, organization, and stakeholder management.
• Fluent German and English communication skills.

Responsabilités

• Lead analytical activities including optimization, transfer, validation, and troubleshooting, ensuring methods are fit-for-purpose.
• Provide scientific and technical expertise in analytical methods, technologies, and experimental strategies.
• Ensure cGMP compliance, data integrity and rigorous documentation across activities.
• Identify risks and drive solutions related to analytical performance, deviations, and timelines.
• Lead the implementation and transfer of analytical technologies across Celonic sites.
• Collaborate with project teams, SMEs, external partners, and client-facing teams.
• Share expertise and develop technical capability through coaching and knowledge sharing.
• Promote continuous improvement, safety, and compliance within Analytical Services.

Connaissances

HPLC methods

Analytical development

Data integrity

cGMP compliance

Analytical problem-solving

Formation

MSc/PhD in Biology/Chemistry/Biotech

Description du poste

Celonic is a \"Pure Play\" Biologics Contract Development Manufacturing Organization (CDMO). Celonic’s mission is to help its customers, primarily small to large Biotech Companies, bring life- saving and improving drugs effectively to the market using innovative, \"next generation\" bioprocessing technologies. Celonic has a state-of-the-art Biologics Development and Innovation Center in Basel, Switzerland (headquarters), and clinical and commercial GMP manufacturing facilities in Heidelberg, Germany. At present, more than 500 highly qualified employees work at Celonic's. Due to the expansion of the company, Celonic is looking for committed and qualified employees.

THE POSITION

As Analytical Lead QC Protein Analytics / Chemical Analytics (f/m/d), you will take ownership of analytical activities within your assigned area, ensuring high scientific standards, quality, and on time delivery. You will lead and coordinate analytical activities across optimization, transfer, validation, and troubleshooting, providing scientific and technical expertise to ensure robust, fit for purpose analytical solutions in line with cGMP and analytical lifecycle requirements. Acting with a high degree of autonomy, you will serve as a key interface between QC-Chemical Analytics, project teams, client facing functions, and external partners. You will also contribute to the implementation and transfer of innovative analytical technologies across Celonic sites, supporting knowledge sharing and technical excellence.

You will report directly to the Team Manager QC Chemical Analytics and operate as a technical leader without direct people-management responsibility.

YOUR RESPONSIBILITIES

• Lead analytical activities including optimization, transfer, validation, and troubleshooting, ensuring methods are scientifically sound and fit-for-purpose.
• Provide scientific and technical expertise in analytical methods, technologies, and experimental strategies, supporting complex analytical challenges by problem-solving and decision-making.
• Ensure cGMP compliance, data integrity, and scientific rigor across analytical activities, documentation, data evaluation, and reporting, including the preparation and review of protocols, SOPs, reports, and other technical documents.
• Identify risks and proactively drive solutions related to analytical performance, deviations, documentation, timelines, and other operational challenges.
• Lead the implementation and transfer of analytical technologies across Celonic sites and functions, ensuring effective knowledge transfer and successful technical implementation.
• Collaborate across functions, working closely with project teams, SMEs, support functions, external partners, and client-facing teams to align analytical activities with project and business priorities.
• Share expertise and develop technical capability by coaching and training colleagues, supporting knowledge sharing, and continuously developing expertise in emerging analytical technologies and approaches.
• Promote a culture of continuous improvement, innovation, safety, and compliance within Analytical Services.

JOB REQUIREMENTS

• MSc, PhD, or equivalent degree in Biology, Biotechnology, Chemistry, Chemical Engineering, or a related scientific discipline.
• 8+ years of relevant experience in pharmaceutical, biotechnology, CDMO, or a comparable analytical environment.
• Strong practical experience in analytical development, method optimization, transfer, validation, and cGMP-regulated activities.
• Strong practical experience in analytical methodology ( HPLC (RP, SEC, AEX), CE, Photo-spectrometry, PAGE, IEF)
• Strong knowledge of analytical method lifecycle, validation principles, European Pharmacopoeia, ICH guidelines, and CMC / regulatory expectations.
• Proven ability to lead complex analytical activities, solve challenging analytical problems, and coordinate work across functions and organizational boundaries.
• Strong experience with analytical documentation and data evaluation, combined with a high level of scientific rigor and attention to data integrity.
• Excellent planning, prioritization, organizational, and stakeholder-management skills, with the ability to work autonomously and manage competing priorities.
• A collaborative and agile mindset, with the ability to influence through technical expertise and sound scientific judgment rather than formal authority.
• Excellent communication skills and fluent German and English

WHY CELONIC?

• Make a difference by directly impacting patients lives
• Biologics is an attractive, high growth sector with professional development
• Offers a multinational and diverse workplace
• Proud to be a pioneer in \"Next Generation\" manufacturing technologies
• Family owned: Entrepreneurial, and short communication lines
• Heidelberg is a great place to live, play and work in the center of Europe