Teva Senior Director Global MS & Sterile Biopharmaceutical Products 

United States, New Jersey 

87648994

Process Optimization and scale-up

• Support process development, optimization, and scale-up of sterile and biologics manufacturing processes.
• Work collaboratively with internal teams to design robust manufacturing systems, ensuring they meet performance, scalability, and quality standards.
• Implement process improvements, new technologies, and innovations in the sterile and biopharmaceutical production lines.

Regulatory Compliance and Risk Management

• Ensure manufacturing processes meet all regulatory requirements (FDA, EMA, ICH, GMP, etc.) and industry best practices.
• Conduct risk assessments for sterile and biologic product manufacturing and implement mitigation strategies.
• Support Preparation of technical reports and documentation to support regulatory filings and inspections.

Technology Transfer

• Oversee the technical transfer of manufacturing processes from R&D to commercial scale.
• Support technology transfer between internal and external manufacturing sites.
• Develop and maintain best practices for the transfer of sterile and biologic processes to different global locations.

Launches and commercialization

• Lead the MS&T efforts in the launch and commercialization of new biologic and sterile products, ensuring smooth transitions from R&D to production at global manufacturing sites.
• Collaborate with cross-functional teams, including R&D, Quality, Regulatory, and Supply Chain, to ensure timely and compliant commercialization of products.
• Oversee the preparation and review of technical documentation, ensuring all regulatory and quality standards are met for launch
• Ensure that manufacturing processes are scalable and reproducible during commercialization, addressing any process challenges that may arise.
• Provide technical support for initial production runs, managing the scale-up process, troubleshooting, and process optimization to guarantee product quality and supply continuity.
• Support the development and implementation of launch strategies for global markets, working closely with regional teams to align manufacturing processes with market requirements.

Collaboration and Stakeholder Engagement

• Work cross-functionally with R&D, Quality Assurance, Supply Chain, and Operations teams to ensure the seamless delivery of biologics and sterile products.
• Provide technical leadership in troubleshooting and resolving manufacturing issues.
• Support the global MS&T team in creating and executing strategies that ensure high-quality and reliable supply.

Training and Knowledge Sharing

• Provide training and guidance to junior team members and site operations teams in the areas of sterile and biologic product manufacturing.
• Act as a subject matter expert (SME) for sterile and biologic products across global manufacturing sites.
• Promote the sharing of best practices and new innovations to foster continuous improvement across the organization.

Continuous Improvement and Innovation

• Lead continuous improvement initiatives and incorporate cutting-edge technologies to improve product quality, efficiency, and cost.
• Foster a culture of innovation within MS&T through the application of novel technologies and methodologies (e.g., automation, advanced analytics).
  

• Bachelors Degree is required.
• Master’s or Ph.D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, or a related field is preferred.
• Minimum of 10 years of experience in Manufacturing Science and Technology, with a strong focus on sterile products (injectables, biologics, etc.) in a GMP environment.
• Prior experience in managing or overseeing technology transfers across regional manufacturing sites is required.
• Proven expertise in biopharmaceutical manufacturing processes such as cell culture, fermentation, purification, sterile fill-finish, and packaging.
• Extensive knowledge of sterile product technologies, including aseptic processing, validation, and cleanroom environments is required.
• Expertise in process design, process validation, and process optimization.
• Familiarity with modern technologies such as single-use systems, automation, and continuous processing.
• Advanced understanding of regulatory requirements and industry guidelines (FDA, EMA, ICH, GMP).
• Proven ability to lead cross-functional teams and collaborate with stakeholders at all levels.
• Strong communication, presentation, and training skills, with the ability to convey complex technical information to diverse audiences.
• Ability to work in a fast-paced, global environment with multiple stakeholders.
• Willingness to travel internationally as required.

Preferred Qualifications:

• Experience with biologic product lifecycle management.
• Expertise in analytical techniques for biologics and sterile product testing.
• Prior experience in managing or overseeing technology transfers across global manufacturing sites.
  

We offer a competitive benefits package, including:

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.