Freelance/Contract Principal Analytical Consultant

ProPharma; Berlin; Hybrid; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

ProPharma seeks an Analytical Consultant to drive the analytical strategy for a pegylated enzyme program. The role requires SME-level expertise and leadership across project teams, with hands-on SEC-HPLC development for Phase 3 registrations.

Ideal candidates hold a PhD or MSc with substantial industry experience, fluent English, and a proven track record in supporting unlicensed medicines toward FDA registration. The position offers remote but emphasizes hybrid collaboration as needed.

Qualifikationen

• PhD in a scientific discipline or MSc with substantial project experience.
• Proven SME in analytical development for pegylated enzyme therapies.
• Hands-on SEC-HPLC method development experience (Phase 3).
• 10–15 years of industry experience; longer possible.
• Fluent in English.

Aufgaben

• Design, implement and manage the analytical strategy for a pegylated enzyme program.
• Provide SME guidance across the project and cross-functional teams.
• Lead and support SEC-HPMC method development and validation for Phase 3.
• Assess analytical risks and develop mitigation strategies.
• Contribute to project/scientific team discussions with sound guidance.
• Support the client as needed.

Kenntnisse

Analytical development

SEC-HPLC

English fluency

FDA registration support

Ausbildung

PhD in a scientific discipline

MSc with substantial project experience

Tools

SEC-HPLC instrumentation

Jobbeschreibung

Analytical Consultant – Pegylated Enzyme Therapeutic Program

We are currently partnering with a Biological group that urgently seeks a Principal/Senior level Analytical Consultant to support a key project on a remote basis. The project involves a pegylated enzyme protein program requiring SME level expertise.

Key Responsibilities

• Design, implement and manage the analytical strategy for a pegylated enzyme therapeutic program.
• Work across the team as an SME to provide key guidance across the project.
• Lead and support SEC-HPMC method development and validation for Phase 3 registration activities.
• Assess analytical risks and develop mitigation strategies to support program objectives.
• Key participation within project/scientific teams and offer sound advice/guidance on analytical development strategies.
• Overall support the client as and when directed.

Required Skills & Qualifications

• Ideally educated to a PhD level in a scientific discipline or at least a MSc with substantial experience linked to the project.
• Must have a proven SME level in analytical development in the above area.
• Hands‑on experience of SEC-HPLC method development is a must at Phase 3.
• 10‑15 years experience overall working in the industry (more would also be suitable).
• Proven track record in supporting unlicensed medicines through troubleshooting phases to FDA registration.
• Fluent in English.
• Can perform the project as set out in the above job description.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us – whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in‑person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.