Biochemist - CMC Mangement Biopharmaceutical Products (m/f/d)

Beschreibung

Passion for Innovation. Compassion for Patients.

Daiichi Sankyo and its 16,000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In Europe, we focus on two areas: In the cardiovascular space, our strong portfolio of medicines reflects our long-standing commitment and shows that we care for every heartbeat; in oncology our goal is to become a global pharma innovator until 2025 by providing novel therapies to patients across the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries. For more information: www.daiichi-sankyo.eu.

For our offices in Pfaffenhofen an der Ilm and/or Munich we are seeking highly qualified candidates to fill the position:

Senior Manager CMC Management (m/f/x)



The position:

The position Senior Manager CMC Management includes knowledge-based coordination and management of multiple projects and related CMC development sub-teams to expedite successful biopharmaceutical product development and regulatory approvals. The qualified candidate will coordinate development strategies and operational plans across a portfolio of projects.

He/she will be mainly accountable for the management of late-stage pharmaceutical development activities in EU region, including tasks such as commercial product development, scale-up, tech transfer to external and internal manufacturing partners, clinical trial material production, process validation, and regulatory submission.

He/she ensures that these plans are aligned within the Global Pharmaceutical Technology (PT) function as well as the overall development and launch preparation plan. Furthermore, the Senior Manager CMC Management will represent EU regional CMC sub-teams within the global project teams. This requires both, strategic as well as operational focus and liaison with global peers and senior management.Roles and responsibilities:

• Matrix leadership and coordination of EU CMC development teams (EU CMC sub-teams) for drug development candidates in clinical-phase as well as life-cycle management and post-approval manufacturing expansions
• Responsible for the establishment of integrated global and regional CMC operational plans and overseeing their execution. This includes strong alignment with the involved subject-matter expert functions such as Drug Substance Development, Drug Product Development, Analytics, QP, Quality Assurance, Regulatory, Clinical supplies, and Supply Chain
• Provide project management and operational oversight of vendor (CXO) services, managing timelines, budgets and deliverables, and coordinating the input of technical and functional experts as required; CXO services covered include drug substance manufacturing, drug product manufacturing, and analytical testing
• Representation of CMC sub-teams on cross-functional drug development and life cycle management project teams
• Ensure alignment of CMC operational plans with overall project plans; facilitate the timely execution of drug development project plans through proactive management of operational interfaces between the CMC development team and other functions
• DSE representative in global Working Teams and initiatives to transform and optimize CMC Management, CMC Planning, and global PT function

Personal skills and professional experience:

• Ph.D. in biochemistry, biochemical engineering, pharmacy, or other discipline within biotech sciences with a minimum of 3 years pharmaceutical/CMC development and/or production experience, or a corresponding Master’s/Bachelor’s degree with a minimum of 5 years’ experience
• Strong experience and know-how in drug substance and drug product development, and/or production of biopharmaceuticals.
• Hands-on late-stage scale-up and production experience in monoclonal antibody production (downstream and/or upstream)
• Experience in quality assurance and change control management
• Experience in collaboration with CXOs
• Proven know-how to collaborate with functional representatives to anticipate and identify project risks and develop action and resolution plans
• Ability to work effectively with cross-functional stakeholders in a complex/evolving global environment
• Demonstrated matrix management skills and clear ability to influence and effectively align the team to progress project goals in a cross-functional environment
• Must be flexible in response to changing priorities due to various time zones (EU, US & Japan)
• Strong Microsoft Office working knowledge

The following is preferred:

• Experience in late-stage development (scale-up, tech transfer, process validation, post-approval change management, CMC regulatory strategy development and regulatory filings) of complex biopharmaceutics such as Antibody-Drug Conjugates or other new antibody formats

What we offer

• Excellent Benefits
• Work-Life Balance
• Growth and Development
• Health and Wellbeing Support