General Description:

Establish a stability program in Quality Control for clinical and commercial phase biologics products in accordance to FDA/EU regulations, applicable International Regulations and BeiGene processes and procedures. Oversee and manage stability studies to deliver scientifically sound GMP test data in accordance to predefined protocols. Oversee the Quality Control sample management program. Develop and implement quality control processes and procedures and support regulatory compliance inspections. Ensure the efficient and effective day to day running of the stability and sample management programs.

Essential Functions of the job :

• Establish and manage the QC stability program for clinical and commercial phase biologics products.

• Ensure timely completion of stability testing and generation of stability reports in support of regulatory submissions.

• Author stability study protocols and reports that are compliant with FDA/EU and ICH requirements.

• Establish, update, implement, and enforce Quality Control procedures and specifications consistent with cGMP, regulations, appropriate compendia, and BeiGene policies and standards.

• Coordinate with sample management and the testing laboratories to ensure stability time points are pulled and tested within the acceptable timeframes in accordance with approved study protocols.

• Create trend reports and assess study data to identify data anomalies, out-of-trends, and out-of-specifications.

• Lead laboratory investigations for data anomalies, out-of-trends, and out-of-specifications. Ensure appropriate CAPAs are implemented to prevent recurrence.

• Oversee the QC sample management program, including management of stability samples, on-test samples, retention samples, reference standards, and critical reagents.

• Manage the issuance and reconciliation of QC test records.

• Issue Certificates of Analyses (COA) to support batch disposition of manufactured products.

• Participate in internal and external GMP audits, as needed.

• Ensure all QC activities are performed in accordance with GMP regulations, company SOPs and Health and Safety policies.

• Managing, motivating, coaching and mentoring direct reports, to higher levels of management capability.

• Undertaking any other duties, either for this department or any other department within the business, which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood.

Core Competencies, Knowledge and Skill Requirements

• Scientific degree (ideally pharmacy, pharmaceutical sciences, chemistry or related).

• Minimum of 8 years’ experience in biological drug product quality control in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required.

• Minimum of 5 years’ experience in management, with training and knowledge of Data Integrity Guidance and Data Management Systems utilized in a Quality operations.

• Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.

• Wide knowledge of analytical methods and electronic systems (LIMS, SAP) used in QC Lab.

• Extensive knowledge with stability trending and associated software application tools.

• Strong leadership/team management skills and experience.

• Credible and confident communicator (written and verbal) at all levels.

• Strategic thinker with the ability to influence at a senior level.

• Highly customer focused.

• Strong analytical and problem solving ability.

• Excellent project management skills.

• Hands-on approach, with a ‘can do’ attitude.

• Ability to prioritize, demonstrating good time management skills.

• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.

• Self motivated, with the ability to work proactively using own initiative.

• Committed to learning and development.

• Highly Desirable:

• Good IT skills e.g. Microsoft Office (Word, Excel and Outlook)

Significant Contacts

• Interacts with all levels of BeiGene employees;

Supervisory Responsibilities:

• Manage direct reports from QC

Computer Skills:

• Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)

Education Required:

Bachelor or above of Science Degree in a related scientific discipline

Travel:

• Must be willing to travel approximately 10%

• Ability to work on a computer for extended periods of time

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.