Job Details

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 Drug Product Manufacturing site in New Jersey (Hopewell). This role will lead the site drug product MST function to support technology transfer, validation, continued process verification, investigations, change management and manufacturing startup. Reporting to the MST leadership, this role is responsible for managing the technical operations supporting both clinical and commercial manufacturing activities.**Essential Functions:*** Serve as MST DP Subject Matter Expert (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 related activities* Support engineering teams on equipment selection, qualification, and start up activities.* Establish CPV program for process performance* 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.* 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 Technical Development to successfully transfer Drug Product processes including final formulation, parenteral vials and lyophilized products.* Lead investigations and resolve complex manufacturing issues.* Manage and coordinate global change ensuring stakeholders alignment. Assist in Regulatory filings and Health Authority site inspections to license and maintain BeOne's pipeline and product portfolio.**Required Education/Experience:*** BA/BS or higher in science, biochemistry, biotechnology, biology, chemical engineering and/or related discipline.* Expert level knowledge in Drug Product aseptic filling operation including, isolators, lyophilizers, and automated inspection.* Expertise in late stage/commercial biopharmaceutical Drug Product technology transfer, process characterization and process validation.* Experience leading execution of PPQ activities, including authoring protocols and reports.* Leading investigations and CAPA for major deviations.* Experience with CPV and lifecycle process improvements.* 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.**Preferred Skills/Experience*** Facility Start-Up* Commissioning, Qualification & Validation* Equipment and/or Process Design* Quality Risk Assessments* Health Authority Interaction/Audits* OE and/or LEAN Methodologies* Distributed Control system / Control Systems* Deviation Assessments / Investigations* SAP, LIMS, CMMS, Veeva**Professional Experience*** Minimum of 8+ of experience working in Biopharmaceutical DP process development or manufacturing experience**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 at least 40 hours/week (on-site).* 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.**Computer Skills:** Familiarity with computer-based systems. Word, Excel, and PowerPoint a must.**Other Qualifications:** Health authority inspections (FDA, EMA, ICH regulations and guidelines). Execution and optimization of controlled procedures. Technical and business writing. Business process development.**Travel:** International and domestic – periodically.Global CompetenciesWhen 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.* Fosters Teamwork* Provides and Solicits Honest and Actionable Feedback* Self-Awareness* Acts Inclusively* Demonstrates Initiative* Entrepreneurial Mindset* Continuous Learning* Embraces Change* Results-Oriented* Analytical Thinking/Data Analysis* Financial Excellence* Communicates with ClaritySalary Range: $141,500.00 - $191,500.00 annuallyBeOne 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 ...@beonemed.com.#J-18808-Ljbffr