BeOne Medicines
Senior Director, Manufacturing Science and Technology
BeOne Medicines, Hopewell, New Jersey, us, 08525
Senior Director, Manufacturing Science and Technology Join to apply for the
Senior Director, Manufacturing Science and Technology
role at
BeOne Medicines Senior Director, Manufacturing Science and Technology 1 day ago Be among the first 25 applicants Join to apply for the
Senior Director, Manufacturing Science and Technology
role at
BeOne Medicines Get AI-powered advice on this job and more exclusive features. 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.
Do you have the right skills and experience for this role Read on to find out, and make your application.
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.
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.
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 Clarity
Salary Range: $203,800.00 - $273,800.00 annually
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.Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionManagement and Manufacturing Referrals increase your chances of interviewing at BeOne Medicines by 2x Sign in to set job alerts for “Senior Director Manufacturing” roles. Branchburg, NJ $190,000.00-$225,000.00 1 week ago General and Operations, Director (Site Management)Senior Director Facilities and EngineeringSenior Director, Facilities and Engineering Edison, NJ $115,000.00-$135,000.00 4 days ago Manager / Director – CMC Regulatory and Manufacturing OperationsSenior Director, Regulatory CMC (Chemistry, Manufacturing, and Controls) East Brunswick, NJ $85,000.00-$115,000.00 1 month ago Operations Director OB/GYN/MFM - FT - Day - Capital Health Medical GroupDirector, Congress Innovation, Operations and Capabilities New Jersey, United States $87,500.00-$87,500.00 2 days ago Director, Utility Operations & Engineering Newtown, PA $73,695.00-$96,928.00 4 days ago Director, Medical Information and Operations, US (f/m/d) New Jersey, United States $128,000.00-$238,000.00 1 day ago Senior Manager, Development to Launch AnalyticsAssociate Director, Site IT and Manufacturing Systems Lead We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Senior Director, Manufacturing Science and Technology
role at
BeOne Medicines Senior Director, Manufacturing Science and Technology 1 day ago Be among the first 25 applicants Join to apply for the
Senior Director, Manufacturing Science and Technology
role at
BeOne Medicines Get AI-powered advice on this job and more exclusive features. 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.
Do you have the right skills and experience for this role Read on to find out, and make your application.
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.
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.
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 Clarity
Salary Range: $203,800.00 - $273,800.00 annually
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.Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionManagement and Manufacturing Referrals increase your chances of interviewing at BeOne Medicines by 2x Sign in to set job alerts for “Senior Director Manufacturing” roles. Branchburg, NJ $190,000.00-$225,000.00 1 week ago General and Operations, Director (Site Management)Senior Director Facilities and EngineeringSenior Director, Facilities and Engineering Edison, NJ $115,000.00-$135,000.00 4 days ago Manager / Director – CMC Regulatory and Manufacturing OperationsSenior Director, Regulatory CMC (Chemistry, Manufacturing, and Controls) East Brunswick, NJ $85,000.00-$115,000.00 1 month ago Operations Director OB/GYN/MFM - FT - Day - Capital Health Medical GroupDirector, Congress Innovation, Operations and Capabilities New Jersey, United States $87,500.00-$87,500.00 2 days ago Director, Utility Operations & Engineering Newtown, PA $73,695.00-$96,928.00 4 days ago Director, Medical Information and Operations, US (f/m/d) New Jersey, United States $128,000.00-$238,000.00 1 day ago Senior Manager, Development to Launch AnalyticsAssociate Director, Site IT and Manufacturing Systems Lead We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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