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Reporting to the Vice President, General Manager of U.S. Manufacturing, Hopewell, NJ., this position plays a leading role in driving process robustness, technology transfer and process troubleshooting. This position involves close collaboration with the CMC, Process Development, Manufacturing, Quality Control, Quality Assurance and Regulatory groups. This position requires advanced technical expertise in mammalian cell culture processes, protein purification, formulation, filling and packaging. A deep understanding of protein product quality attributes associated scientific areas and advanced data analysis skills. Of equal importance is the ability to lead and develop report.

Essential Functions of the Job:

+ Leading, mentoring and development of staff is a critical part of the responsibility.

+ Recognizing and rewarding strong performance.

+ Managing poor performance.

+ Grow & develop the team.

+ Set direction and inspire.

+ Effective communication with team members and stakeholders.

+ Provide oversight and guidance for technology transfers.

+ Drive tech transfer schedule commitments.

+ Provide scientific leadership for the site and company with the aim to ensure steady product supply, process robustness and a focus on cost of goods reduction.

+ Scale-up through technology/process transfer to clinical and commercial manufacturing.

+ Ensure accurate and complete documentation of any scientific experimental plans, data and reports.

+ Uphold all cGMP standards for process qualification, deviation investigations and all related documentation.

+ Utilize fundamental engineering principles relevant to bioprocess unit operations for scale-up and technology transfer.

+ Participate in and support on-site supervision and management of contract manufacturers as required by BeOne.

Technical/Skills Required:

+ Process and Equipment knowledge related to cell culture, purification and fill-finish as well as analytical instruments commonly used in biopharmaceutical labs and manufacturing.

+ Experienced in Process Scale up, Tech transfer, solving manufacture related issue, and with project management skill.

+ Experienced in regulations, guidelines of FDA, ICH, PDA.

+ Direct experience with regulatory audits (FDA, etc)

Supervisory Responsibilities:

+ Leading, mentoring and developing staff is a critical aspect of the role.

+ Broad knowledge of drug development, CMC, MST, preclinical and clinical requirements.

+ Experience in effectively managing scientific groups and projects.

+ Demonstrated effective communication, oral and written, in a multi-disciplinary, project-driven work environment.

+ Demonstrated skill in leading project teams tasked with resolving complex production related issues.

+ Familiarity with EMA and FDA regulatory requirements for process development submissions.

Other Qualifications:

+ BS in Chemistry, Biochemistry, Pharmaceutics, Pharmaceutical Science, Chemical or Biomedical Engineering, or related scientific discipline and 12+ years of relevant experience.

+ MS or PhD and 8+ years of relevant experience required.

+ Experienced in raw material characterization, biological manufacturing upstream, downstream and drug product manufacturing development and production operations at various scales.

+ Familiarity with EMA and FDA regulatory requirements for process development submissions.

Travel:

+ Some travel may occur because of duties assigned to the role. This will not be extensive, perhaps a few times per calendar year.

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.