Senior Engineer – Drug Substance Manufacturing

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:

The preferred candidate will possess technical expertise in commercial-scale monoclonal antibody (mAb) production, supporting Upstream or Downstream manufacturing operations and their related systems and equipment. The primary objective is to support the start-up and licensure of BeiGene’s newest drug substance production facility in Hopewell, NJ.

The Senior Engineer role is responsible for providing subject matter expertise to develop scalable, robust, and controlled cGMP-ready processes to ensure a successful facility, equipment, and process start-up; improve process control, yield, and product quality and/or productivity. This will include supporting high-impact, cross-functional teams to execute technology transfers, troubleshoot process and equipment defects, perform deviation/investigation root cause analysis and impact assessments, support regulatory inspections, and author change records.

The duties of the role will be principally engaged in two major phases:

• Support and execute the design, start-up, validation, and licensure of BeiGene’s first biopharmaceutical facility in the United States.
• Support all activities required to enable reliable and compliant execution of DS and DP cGMP operations (deviation evaluation, process monitoring, change management), drive process optimization, and enable the technology transfer of new products to the facility.

Essential Functions of the job:

• Proactively identifies, shares, and implements improvement opportunities that support BeiGene’s vision and mission.
• Statistical analysis, modelling, testing, and system optimizing are essential skills honed through experience, proficiency with finding challenges and solving them through technology and innovation.
• Leverage strong interpersonal and collaboration skills to develop and sustain a positive rapport with internal and external stakeholders throughout all phases of facility and equipment design, FAT, commissioning, and start-up.
• Scale-up through technology/process transfer to clinical and commercial manufacturing.
• Review CMC sections and ensure the accuracy of submissions.
• Effective communication with team members and stakeholders is a must.
• Participate in and support on-site supervision and management of contract manufacturers as required by BeiGene.
• Any other assignment as is determined by supervisor.

Physical Requirements:

• Must be able to stand for long periods, up to 8 to 10 hours/day.
• Must be able to reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently.
• Must be able to work scheduled 40 hours with the ability to work overtime as needed.
• Must be comfortable in working in varying temperatures.
• Frequent lifting, pushing, pulling, and carrying.  Ability to lift up to 40 lbs.
• Regular reaching, bending, stooping, and twisting.
• Repetitive motion and substantial movement of the wrists, hands, and/or fingers.
• Environment requires dedicated gowns, depending on area.
• Work with hazardous materials and chemicals.
• Willing to work any shift.

Qualifications:

• BS or MS in pharmaceutical Science, Engineering, or advanced scientific discipline.
• Minimum of 5+ years of process engineering experience in a commercial biopharmaceutical facility.
• Process and equipment knowledge related to cell culture operations from vial thaw through bulk filtration, as well as analytical instruments commonly used in biopharmaceutical labs and manufacturing.
• Experience with vendor management, including selection and qualification
• Technical Transfer experience, including equipment qualification and process validation
• Experience working on project teams tasked with resolving complex production related issues 
• Previous experience with deviation and change management systems
• Strong interpersonal and teamwork skills
• Strong self-management and organizational skills
• Oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization, and in a multi-disciplinary, project-driven work environment
• Possesses a working knowledge on relevant biopharma FDA regulations, (FDA, EMA, ICH, PDA)
• Broad knowledge of drug development, CMC, preclinical and clinical requirements