Senior MSAT Manager API (m/f/d)

CHEPLAPHARM Arzneimittel GmbH; Berlin, Frankfurt, Greifswald; Remote; EUR 85,000 - 140,000; Full time

Benefits offered by this job

Flexible working models

30 days holiday

Pension provision

Discount platform

Job summary

CHEPLAPHARM Arzneimittel GmbH seeks a Senior Technical Expert to drive complex technology transfer programs and MSAT initiatives, ensuring high-quality execution from planning to implementation.

Responsibilities include on-site GMP compliance assessments, review of critical documentation, and collaboration with external service providers to deliver compliant products and processes in an international setting.

Qualifications

• Master's degree in a related scientific discipline plus 5+ years in pharma/biotech MSAT/tech transfer, manufacturing or technical operations.
• Experience in API development or manufacturing is preferred.
• Strong GMP/regulatory knowledge and international experience.
• Excellent communication and stakeholder management in a matrix environment.

Responsibilities

• Lead complex technology transfer projects from planning through implementation.
• Perform on-site technical compliance assessments and verify regulatory adherence.
• Review and maintain GMP-relevant documentation for product/process transfers.
• Provide expert guidance on pharmaceutical technical matters across medicinal and non-medicinal products.
• Coordinate cross-functional projects and manage external service providers.

Skills

GMP knowledge

Regulatory expertise

Project management

Cross-functional leadership

Communication skills

Problem solving

Education

Master's degree in Pharmacy

Master's degree in Biotechnology

Master's degree in Life Sciences

Master's degree in Chemical Engineering

Job description

What makes your day with us special:

Leading Complex Technology Transfer Programs
You ensure the successful technical execution of technology transfer projects and MSAT initiatives, driving projects from planning through implementation while maintaining the highest quality standards.

Ensuring Technical Compliance Excellence
You perform on-site technical compliance assessments and verify that all activities meet internal requirements as well as applicable international regulatory standards.

Managing Critical Technical Documentation
You review, approve, and maintain technical documentation required for product and process transfers, ensuring accuracy, consistency, and compliance throughout the project lifecycle.

Acting as a Senior Technical Expert
You provide expert guidance on pharmaceutical and technological matters, supporting both medicinal and non-medicinal products and helping teams navigate complex technical challenges.

Driving Regulatory Compliance and Leading Technical RFQ Activities
You ensure adherence to relevant international regulations and industry standards, contributing to the successful delivery of compliant products and processes. You take ownership of the technical evaluation and contribution to Request for Quotations (RFQs), providing expert input to support business development opportunities.

Collaborating with External Service Providers
You act as the primary technical contact for external service providers involved in technology transfer projects, building strong partnerships and ensuring successful project delivery.

Maintaining GMP-Critical Documentation
You create, review, and continuously improve GMP-relevant documentation, including SOPs, risk assessments, specifications, manufacturing instructions, packaging instructions, and validation documents.

Managing Cross-Functional Projects
You coordinate complex projects across multiple functions and departments, aligning diverse stakeholders and ensuring project milestones are achieved on time and in scope.

What sets you apart:

Academic Background and Pharmaceutical Industry Experience
You hold a Master's degree in Pharmacy, Biotechnology, Life Sciences, Chemical Engineering, or a related scientific discipline. You bring more than 5 years of relevant professional experience within the pharmaceutical or biotechnologyindustry, ideally within MSAT, technology transfer, manufacturing, or technical operations and Experience in API.

Proven Project Management Expertise
You have successfully managed complex, long-term projects involving multiple stakeholders, changing priorities, and cross-functional collaboration.

Technical Knowledge and Problem-Solving Skills
You possess strong technical expertise and enjoy analyzing complex challenges, evaluating alternative solutions, and driving practical, sustainable outcomes.

GMP and Regulatory Expertise and Outstanding Communication Skills
You demonstrate a thorough understanding of GMP requirements, pharmaceutical regulations, and industry best practices within an international environment. You confidently engage with stakeholders at all organizational levels and are skilled at influencing, negotiating, and building strong professional relationships.

Matrix Leadership Capabilities
You have experience leading cross-functional teams and projects in a matrix environment, driving results through collaboration, influence, and expertise rather than direct authority.

Proactive and Independent Mindset
You take ownership of your responsibilities, make sound decisions, and thrive in dynamic environments where flexibility and initiative are essential.

What we offer you besides the job:

Corporate culture & internationality
A growing company with a diverse, open working environment and employees from around 40 countries.
Flexible working models & work-life balance
Individually customisable working models, including the option to work from another EU country for up to two months per year. Working time account with compensatory time off and 30 days of holiday.
Individual benefits & pension provision
Flexible benefits budget, e.g. for increased company pension provision, fitness and health offers or subsidies for travel and meal costs.
Discounts & additional benefits
Access to the corporate benefits platform with discounts at hundreds of partner companies.
Further development & team culture
Internal and external training courses tailored to personal goals, as well as company and team events to strengthen cohesion and celebrate successes together.