Principal Scientist, Drug Product

Principal Scientist, Drug Product

In order to make an application, simply read through the following job description and make sure to attach relevant documents.

Principal Scientist, Drug Product

Apply locations Hopewell time type Full time posted on Posted 2 Days Ago job requisition id R27163

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description :

This role in the Manufacturing Science and Technology (MST) department supports BeiGene’s Drug Product Manufacturing Technology Transfer and support. Based in New Jersey (Hopewell), this role will be to lead the Hopewell drug product MST function to support technology transfer, validation, continued process verification, investigations, change management, and site startup of Hopewell internal drug product manufacturing activities. Reporting to the MST leadership, this role is responsible for managing the technical operations supporting both clinical and commercial manufacturing activities.

Leadership :

• Serve as MST DP SME and process lead for drug product, ensuring the materials, strategy, and documentation are in place.
• Collaborate with DP / SC / QC / QA to develop testing strategy for DP raw materials and in-process samples.
• Author and maintain process control strategy documents throughout the lifecycle of a program and maintain process risk assessment documents.
• Author PPQ protocols and reports. Oversee execution of PPQ and PPQ related activities.
• Support engineering teams on equipment selection, qualification, and startup activities.
• Monitor and CPV trend process performance, including input and output parameters.
• Responsible for technical transfer, validation, investigation, and technical support of aseptic manufacturing operations in Hopewell and CMOs. Collaborate with Drug Product Operations to establish robust and compliant manufacturing performance.
• Collaborate with Global DP MS&T and Technical Development to enable new DP filling capability at Hopewell Location.
• Provide technical support for Drug Product Operations. Provide input into operational metrics, budgeting, and planning.
• Establish a data and metrics driven culture. Relentlessly maintain alignment with other global manufacturing sites through shared knowledge, shared manufacturing data, shared manufacturing issues, and common solutions.
• Partner with GZ Technical Development to successfully transfer and validate HPW DP processes. Product scope includes parenteral vials and lyophilized products. Collaborate with Technical Development in investigating and resolving complex manufacturing issues at CMOs.
• Manage and coordinate global change ensuring stakeholder alignment. Assist in Regulatory filings and Health Authority site inspections to license and maintain BeiGene’s pipeline and product portfolio.

Essential Functions :

Preferred Skills / Experience :

Qualifications :

Physical Requirements :

Computer Skills : Familiarity with computer-based systems. Word, Excel, and PowerPoint a must.

Travel : International and domestic – periodically.

BeiGene Global Competencies :

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

Salary Range : $127,200.00 - $172,200.00 annually

BeiGene is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA / HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

J-18808-Ljbffr

Salary : $127,200 - $172,200