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Hopewell, Virginia, 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:
Supporting Product commercialization for BeOne, the Senior Manager Packaging Engineering will have a main focus on our Hopewell, NJ manufacturing site, and responsible for commercial packaging qualification for drug substance, drug product, primary container/closure and final product presentations by:
Utilization of standard processes in commercial development and lifecycle management of BeOne products in alignment with the overall manufacturing/packaging capability of BeOne operations at the Hopewell site as well as globally.
Serving as the technical packaging lead in cross-functional teams including packaging site, supply chain, commercial, regulatory, finance, clinical, quality as well as across BeOne to commercialize products that create a successful patient experience.
Assisting in the development of annual goals and strategic direction for the packaging organization aligning with the company overall strategy.
Supporting product launches, tech transfers, and global expansion initiatives at our Hopewell site with packaging expertise.
Ensure all packaging systems, equipment and processes comply with global regulatory requirements (e.g., FDA, EMA, etc.).
Essential Functions of the Job:
Technical Support for the BeOne Hopewell, NJ, directing the design, supporting process, qualification, documentation and implementation of commercial packaging and thermal shipping solutions aligning with the product strategy including:
Manage package development documents (technical drawing, specification, technical assessment, development protocol and report) utilizing the Veeva system.
Develop and execute risk assessment, qualification plan, protocol, and summary report related to component qualification, packaging line testing, and temperature-controlled shipping system.
Support HPW site in commercial launch and after launch efforts, packaging line qualification, pack design and specification, artwork, MBR development, process improvement, and troubleshooting.
Technical support for ongoing packaging activities at the Hopewell site, including process troubleshooting and support for new equipment initiatives.
The pursuit of packaging technologies that will drive innovation and gain efficiency in packaging operations.
Lead commercial packaging engineering activities in market launches and projects to meet predefined timeline and budget.
Manage and execute change controls and deviations related to packaging.
Author regulatory documents in support of product applications or provide regulatory filing and submission support.
Accomplish goals within a team first environment and with respect for all members.
Deliver progress reports and presentations ensuring that management is aware of the current status, progress, and future needs of projects and the organization.
Identify and ensure area of responsibility complies with the most current standards and company policies.
Education and Experience Required:
Bachelor’s degree or and 7 years of Engineering experience or Master’s degree and 5 years of Engineering experience,
Demonstrated experience leading teams, projects, programs or directing the allocation of resources preferably within the biotech, pharmaceutical, CRO, industry.
Supervisory Responsibilities:
Possibly intern supervision
Computer Skills: Proficient in Microsoft Office applications (Word, Excel, and Outlook), ERP Systems.
Other Qualifications: Understands comprehensive global pharmaceutical regulatory requirements (e.g. GMP, GDP). Due to global nature of company early morning or evening meetings may be required.
Travel: Up to 20%
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.
