Senior Director, Manufacturing Science and Technology

BeOne Medicines; Hopewell (NJ); On-site; USD 203,000 - 274,000; Full time

Job summary

BeOne Medicines is seeking a Senior Director of Manufacturing Science and Technology to lead process engineering efforts, mentor staff and ensure regulatory compliance in biopharmaceutical manufacturing. This strategic role involves collaboration across multiple departments to reinforce product quality and drive innovation.

Benefits

Comprehensive benefits package including Medical, Dental, Vision

401(k) and FSA/HSA options

Discretionary equity awards for all employees

Employee Stock Purchase Plan

Qualifications

• 12+ years of relevant experience in biopharmaceutical manufacturing.
• Experience in regulatory audits and compliance.
• Strong leadership and communication skills.

Responsibilities

• Leading and mentoring staff in manufacturing science.
• Overseeing technology transfers and ensuring process robustness.
• Driving compliance and documentation in cGMP standards.

Skills

Process and Equipment knowledge

Process Scale up

Project management

Problem-solving

Education

BS in Chemistry, Biochemistry, Pharmaceutics, or related field

MS or PhD

Job description

Senior Director, Manufacturing Science and Technology

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Senior Director, Manufacturing Science and Technology

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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.

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 level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management and Manufacturing

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