Analytical Lead QC – Biological Analytics (f/m/d)

Celonic Group; Heidelberg; On-site; EUR 120,000 - 160,000; Full time

Job summary

Celonic is a Biologics CDMO with Basel HQ and Heidelberg facilities. We are seeking an Analytical Lead QC - Biological Analytics to own analytical activities, drive optimization, transfer, validation and troubleshooting, and ensure cGMP-compliant, robust, fit-for-purpose solutions across the lifecycle.

You will report to the Team Manager QC Biological Analytics, act as a technical leader without direct people management, collaborate with project teams, SMEs and external partners, and help

Qualifications

• MSc or PhD in biology, biotech, chemistry or related field.
• 8+ years in pharma/biotech/CDMO environments.
• Expert in analytical development, transfer, and validation.
• Experience with analytical methods (Cell-based assays, ELISA, Endotoxin, qPCR).
• Strong knowledge of ICH, European Pharmacopoeia, and CMC expectations.
• Excellent German and English communication.
• Proven ability to coordinate cross-functional teams.

Responsibilities

• Lead analytical activities across optimization, transfer, validation and troubleshooting.
• Provide scientific expertise in analytical methods and tech strategies.
• Ensure cGMP compliance, data integrity, and documentation quality.
• Identify risks and drive solutions with timelines and prioritization.
• Implement and transfer analytical technologies across sites.
• Collaborate with project teams, SMEs, and external partners.
• Coach colleagues and promote knowledge sharing.
• Foster continuous improvement, safety, and compliance.

Skills

Analytical leadership

Cross-functional collaboration

Regulatory understanding

Data integrity

German & English fluency

Education

MSc/PhD in Biology/Biotech/Chemistry

8+ years in pharma/biotech/CDMO

Tools

Cell-based assays

ELISA

Endotoxin assays

qPCR

Job description

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 - Biological 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-Biological 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 Biological 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 (Cellbased Assays, ELISA, Endotoxin Assays, qPCR)
• 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