Head of Physical & Chemical Lab

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

General

·  Performance of physical and chemical package material testing, excipients testing, product stability, release and in-process control testing and necessary trending analysis under Lean lab management.

·  Performance of testing in accordance with cGMP regulations and Roche/Genentech standards and China GMP requirement.

·  Supporting manufacturing operations by timely completion of package material testing and excipients testing.

·  Continuous improvement of processes and technology, in collaboration with ASAT, to drive right first time and efficiencies

·  Ensuring test methods are validated according to relevant cGMP and pharmacopeias in collaboration with ASAT.

·  Supporting investigations due to OOS, OOT, OOE and other production-related issues.

Technical and Functional

 Implement GMP compliance with global GMP standards and China GMP requirement

·  Provide QC staff with technical guidance on test methods and relevant procedures.

·  Ensure timely generation and reporting of test results in support of manufacturing operations.

·  Ensure that data, documentation and laboratory processes are in a constant state of regulatory compliance and inspection readiness.

·  Ensure system, computer, change control and analytical data is reviewed, evaluated and approved against established criteria.

·  Ensure all laboratory operations including test execution, review and data documentation follow cGMP procedures.

·  Collaborate with Lab Support to ensure calibration and maintenance of laboratory equipment and systems.

·  Direct QC Staff in the timely resolution of issues, including discrepancies, investigations and implementation of CAPAs.

·  Escalate any potential quality issues revealed during QC testing or processing of products, especially quality or regulatory issues with the potential to affect product quality or regulatory compliance.

·  Support regulatory inspections and partner audits.

·  Provide QC technical support and oversight to CMO activities

·  Approve protocols and reports (e.g. third-party QC labs, MSAT or QC studies, etc.).

·  Support testing requirement for counterfeit product and special requirement Marketing & BU as well as regulatory compliance requirement from China authority.

·  Build the collaboration between Roche Lab and government lab to support routine product release and trouble shooting.

·  Review and approve analytical record and analytical report

·  Attend quality meeting to support decision making of quality issue

·  Manage the lab operation cost to meet the annual department budget

Leadership and People Management

 ·  Lead and manage all aspects of people processes - organization, staffing, and talent management, performance management to meet strategic and operational objectives. Direct staff in setting operational objectives and business goals for their respective areas of responsibility.

·  Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term. Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.

· As a leader within the Quality Control team, drive network activities and alignment, cross functional planning, and decision making.

· Engage in proactive measures to promote a positive safety culture while ensuring all applicable Safety, Health and Environment requirements are fulfilled in alignment with corporate policy and local legal requirements.

· Embody PT lean principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning.

Education/Qualifications
Bachelor’s Degree (biology, microbiology, biochemistry, chemistry or other relevant discipline is preferred)
 Graduate or higher-level Degree is preferred
 7 or more years’ work experience in the pharmaceutical or related industry
 4 or more years’ people management experience
 3 or more years’ quality, compliance or other relevant experience in the pharmaceutical industry

Job Required Competencies
 Strong knowledge of analytical laboratory operations in support of commercial manufacturing.
 Strong knowledge of compendia test methods (e.g.ChP, USP, EP, JP) for Pharmaceutical Industry
 Expert knowledge of cGMP relevant to the pharmaceutical industry

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.