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Hopewell, New Jersey, United States
Onsite
BeOne 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 BeOne’s Small Molecule Manufacturing Plant, currently in the design phase. The position serves as the site Subject Matter Expert (SME) for Oral Solid Dose (OSD) manufacturing and provides technical leadership for facility design, equipment selection, and start-up activities. It is responsible for leading technology transfer, lifecycle validation, and technical support for commercial manufacturing. Reporting to the Sr. Director of MST, this onsite role is based at BeOne’s U.S. Manufacturing Site in Hopewell, NJ.
Essential Functions of the Job:
Small Molecule expertise in OSD manufacturing processes, including wet granulation, drying, blending, tablet compression and coating.
Familiarity with API manufacturing processes and specifications.
Excellent technical writing skills, including authoring technology transfer plans, validation protocols/reports, Comparability Studies, and regulatory filing documents.
Regulatory Health Authority experience such as inspections and/or Regulatory Submission, and correspondence.
Investigate root causes of major deviations for cGMP manufacturing, and implement CAPA for major deviations
Work with counterparts in Process Development, Process Sciences, Manufacturing, Quality, and CMC Project Management. to facilitate technology transfer and project success.
Expertise in late stage/commercial Drug Product technology transfer, process characterization and process validation.
Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing.
Ability to work both independently and as part of a team.
Ability to function in a fast-paced dynamic team environment and balance prioritize multiple projects
Excellent troubleshooting skills and ability to solve complex technical issues. Ability to compile, analyze and interpret data; Ability to write routine reports and correspondence.
Strong interpersonal and communication skills, verbal and written. Ability to speak effectively before groups of customers. Ability to communicate in a dynamic environment.
Supervisory Responsibilities:
Bachelor’s degree and 10+ years of pharmaceutical industry experience required
Master’s degree and 7+ years of pharmaceutical experience preferred
7+ years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.
Ability to hire, train and develop a technical team to support facility start-up, technology transfer and commercial pharmaceutical manufacturing
Ability to build departmental processes and procedures in support of life cycle validation and technical support.
Cross-functional collaboration experience with key stakeholders including Manufacturing Operations, Quality Assurance/ Control (QA/QC), Facilities and Engineering (F&E) and Regulatory Compliance/ Regulatory Affairs.
Project Leadership experience in fast-paced, complex environments with tight time and cost controls.
Experience leading complex investigations, identification of root causes, and implementation of corrective actions.
Technology Transfer leadership experience with new product introduction or commercial life cycle products.
Life Cycle validation leadership, including Process Design, Process Qualification, and Continued Process Verification.
Collaborate with Global CMC, MS&T and Technical Development to enable new DP manufacturing capabilities at Hopewell Location.
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.
Computer Skills:
Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
Statistical software application experience preferred (JMP, minitab, etc)
Other Qualifications:
Six sigma green/black belt preferred
Travel: Up to 10%
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
BeOne 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 BeOne Medicines 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. BeOne 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.