Associate Principal Scientist Analytical Project Lead 12 months fix-term contract 80-100%

Lonza Group Ltd.; Basel; Vor Ort; Vertraulich; Vollzeit

Zusammenfassung

Lonza Group Ltd. in Basel seeks a senior analytical chemist to lead discussions with customers and SMEs across the DPS Analytics groups. You will ensure milestones are tracked in planning tools and oversee timely delivery of analytics projects and SOWs.

A strong background in analytical method development within GMP contexts is essential. You will shape strategies for analytical programs, maintain molecule knowledge, and drive regulatory-ready data packages while collaborating across matrix

Qualifikationen

• PhD degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field.
• Work experience in analytical development and/or QC, preferably with cGMP experience.
• Very good working knowledge in all relevant analytical techniques.
• Experience with parenteral dosage forms and protein analytics.
• Ability to interpret complex analytical data.
• Capability to work independently and in a team environment.
• Excellent communication, reporting and scientific skills.
• Experience with analytical lifecycle for biotechnology products, CMC requirements for regulatory filings and working in a matrix organization highly desired.
• Excellent knowledge of written and spoken English.

Aufgaben

• Lead analytical discussions with customers and interface with SMEs across DPS Analytics groups
• Ensure project timelines and deliverables are visible and maintained in planning tools
• Oversee delivery of analytical milestones by liaising with DPS Analytics execution groups
• Support Project Leads with analytical SOWs and engage with SMEs and amendments team
• Set up strategy for DPS analytical programs: control strategy, specs, lifecycle, platform methods
• Maintain knowledge of molecules and method strategy, industry trends
• Manage development and evaluation of analytical methods and technologies to support formulation development and Drug Product testing
• Adhere to cGMP regulations as required

Kenntnisse

Analytical chemistry

Biochemistry

cGMP experience

Data interpretation

Team collaboration

English proficiency

Ausbildung

PhD in Analytical Chemistry

Tools

HPLC

CE

UV-Vis

pH measurement

Osmolality

Visual inspection

Jobbeschreibung

What you will get:

• An agile career and a dynamic work culture
• An inclusive and ethical workplace
• Compensation programs that recognize high performance

What you will do:

• Lead analytical discussions with customers and interface with subject Matter Experts (SME) representing all DPS Analytics groups
• Ensure project timelines and deliverables are visible and maintained in relevant planning tools
• Oversee delivery of analytical milestones by liaising with relevant DPS Analytics executional groups
• Support Project Leads with analytical SOWs and engage with SMEs as well as amendments team as required
• Set-up strategy for DPS analytical programs: Control strategy, specifications, analytical method lifecycle, platform methods/ product-specific methods
• Maintain up-to-date knowledge of assigned molecules as well as method strategy, industry issues/trends and pharmacopeia
• Manage development and evaluation of analytical methods and technologies to support formulation development and Drug Product testing (GMP and non-GMP, specifically including HPLC and CE purity methods, content by UV, color, clarity and opalescence, pH, osmolality, extractable volume, CCI, visual inspection).
• Contribute to the design and set up of analytical development processes across DPS
• Adhere to cGMP regulations as required

What we are looking for:

• PhD degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field
• Work experience in analytical development and/or QC, preferably with cGMP experience
• Very good working knowledge in all relevant analytical techniques
• Experience with parenteral dosage forms and protein analytics
• Ability to interpret complex analytical data
• Capability to work independently and in a team environment
• Excellent communication, reporting and scientific skills
• Experience with analytical lifecycle for biotechnology products, CMC requirements for regulatory filings and working in a matrix organization highly desired
• Excellent knowledge of written and spoken English

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow.

Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together.

Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table.

At Lonza, we value diversity and are committed to creating an inclusive environment for all employees.

If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.