Analytical Biochemistry - all genders

Sanofi US; Frankfurt; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading biopharma company in Frankfurt is seeking an Analytical Lead to coordinate analytical activities for biologics. The role requires overseeing bioassays, representing the analytical function in product teams, and developing analytical control strategies. Candidates should have at least 5 years of experience in biopharmaceutical development and a related advanced degree, with proficiency in English. A competitive benefits package is offered.

Leistungen

High-quality healthcare

Paid family leave

Childcare benefits

Qualifikationen

• 5+ years’ experience in development and manufacturing of biopharmaceutical products.
• Fluency in English, verbally and in writing.

Aufgaben

• Coordinate experiments at external suppliers for bioassays.
• Represent the analytical function in technical product teams.
• Lead analytical control strategy specification and comparability activities.

Kenntnisse

Experience with Bioassays

Regulatory requirements knowledge

cGMP knowledge

Interpersonal collaboration

Proactive problem-solving

Ausbildung

PhD or Master in Science

Jobbeschreibung

About the job

Analytical Lead, will serve as a member of Technical Product Team(s) for a product or a portfolio of products and will be responsible for overseeing, leading and coordinating execution of analytical activities for late stage and commercial biologics. Additionally, you will coordinate and follow-up on Insulin-bioassays running at external suppliers.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main responsibilities

• Coordinate and follow-up on experiments at external suppliers for bioassays

• Serve as the primary contact for assigned product / product family for the MSAT Global Analytical function. Represent Global MSAT Analytical in CMC/technical product teams, maintain thorough knowledge of assigned product(s), ensure execution of analytical work within MSAT and externally to support characterization, comparability, investigations, and process development.

• Responsible for development of analytical control strategy specification setting, risk assessment and comparability activities related to new product introduction, process changes, tech transfer, etc. as appropriate.

• Lead / oversee ALCM activities, internally and externally/outsourced as applicable, including assay development, transfer, SME support for assigned product(s).

• Provide input to regulatory dossiers, provide responses to questions from authorities

About you

• Experience: 5+ years’ experience in development and manufacturing of biopharmaceutical products, preferably in analytical sciences. Chemical engineering or Pharmacist

• Soft and technical skills:

  • Experience with Bioassays, development, regulatory requirements, dossier writing, cGMP knowledge, HA regulations

  • Actively making decisions to drive related decision-making processes

  • Enjoying collaboration in interdisciplinary teams and being open and winning with

  • with people

  • Self-employed, organizational and purposeful

  • Ability to present and present even complex contexts accurately and comprehensibly

  • Anticipate risk and bring about proactive, effective and innovative solutions

• Education: PhD or Master in Science (University), Chemistry, Biochemistry, Biotechnology, Chemical engineering or Pharmacist

• Languages: Fluency in English, verbally as well as in writing

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Benefit from a well-thought-out benefits package that rewards your contribution and commitment.

• We take care of you and your family with a wide range of health and social such as high-quality healthcare, numerous prevention programs and coverage for long-term illness. Our 14-week paid family leave for both parents is outstanding as well as a wide range of childcare benefits.

Progress and discovery are at the heart of our work. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com.