POSITION

At Roche, over 90,000 colleagues are working together and doing what patients need next.  Our ambition is to deliver novel therapeutics, diagnostic solutions and insights to patients with game changing clinical benefits.  China Innovation Center of Roche is seeking a Group Leader and (Senior) Principal Scientist of Biologics CMC group with a keen interest and deep knowledge in drug discovery and development, who will contribute to development of the site Biologics Chemistry, Manufacturing and Control (CMC) strategy, from pre-entry into humans through early development (possibly up to phase two).  This colleague will also lead cross-functional Technical Development Team(s) in developing and implementing project CMC strategies and CMC development activities associated with biologics clinical drug candidates.  This leader will catalyze effective collaborations with Discovery, Pharma Technical Development (PTD), other Roche global/Roche China functions and external CRO/CDMO partners.

RESPONSIBILITIES

• Lead the Biologics CMC group to deliver CICoR biologics CMC projects; drive planning and operational excellence of early development CMC projects; manage seamless collaboration with QC, QA, RA, PTD, etc. to deliver biologics CMC projects.
• Development of CICoR site antibody Chemistry, Manufacturing and Control (CMC) strategy covering pre-entry into humans through early development.
• Accountable to coordinate and to prioritize if necessary all available resources (internal and external) to address site biologics portfolio needs.
• As a CMC project lead, accountable for design and execution of project CMC development strategies that include cell line development, cell banking, USP, DSP, formulation, drug product configuration, process engineering, quality controls, and regulatory submissions; execute effective risk mitigation strategies.
• As a CMC project lead, ensure alignment of project CMC strategy with clinical, toxicology, pharmacology, regulatory, marketing/commercial strategies, timelines and corporate goals.
• As a CMC project lead, accountable for all project planning, scheduling, resourcing and reporting for the team.
• Represents the Biologics CMC on the project team, with stakeholders across company and when interacting with external business partners; ensures excellent information flow between team members, to functional management, and to governance committees to ensure transparency, informed decision making, and optimal alignment of all technical deliverables with the project strategy and Clinical Development plan.
• Represents projects to Senior Management and company governance committees and contributes to key business justifications requiring corporate approvals.
• Participate in due diligence effort for potential license-in opportunities.
• Align with Discovery to ensure consistency between Discovery and CMC strategies

CANDIDATE PROFILE

Qualification and experience

The candidate qualifications include a PhD in biology, biotechnology, chemical engineering or related field, along with significant and current knowledge and experience in LM CMC. The candidate ideally is an experienced people leader and needs to have at least 8 years of CMC experience in a pharmaceutical biotechnology industry setting.  The candidate is ideally an expert in cell line development, or USP or DSP but should have a broad knowledge and experience in end to end LM CMC.  Candidates must have a proven track record in CMC and/or product development and evidence of scientific accomplishments.  Proven track record of managing complex matrix organization and cross-functional programs.  Experience in LM CMC regulatory area including IND filing is a plus.

Competencies

This position requires excellent leadership, communication, collaboration, strategic thinking, decision making skills, negotiating skills, influencing skills, and manage matrix organization and complex projects.  The ideal candidate will have demonstrated competence in the following areas:

• Scientific expertise: This candidate should be well recognized in the field with consistent publications in top-tier journals, and presentations at key scientific conferences.  He/she has a strong track record in cell line development and bioprocess development, with recent experience as a biologic CMC lead in a preclinical or clinical setting.  He/she also has excellent knowledge in antibody lead optimization, analytical development, QC, QA, and ideally, CMC development of Mab, bispecific/multi-specific antibodies and antibody SM conjugates.
• Leadership: An effective leader of direct lines as well as matrix teams, who cares the development of his reports and is an excellent motivator and coach.
• Collaboration: The candidate is highly collaborative, internally and in partnerships with external organizations.  He/she seamlessly interfaces with disease areas and global functions and is a part of a strong global research and development network.  He/she embraces humility, responsibility and curiosity.  The role requires an exceptional leader with a desire to work with peers and partners in order to meet goals.
• Communication: Exceptional communication skills for navigating and seeking opportunities within our internal and external networks.
• Agile and innovative mindset: Always ready to step out of the box for creating and exploring new ideas.  Yet is results driven.  The candidate we seek is energized by challenges, is not afraid of taking risks.  The candidate always takes full ownership and responsibilities.