Director of Process Development

Vintti is a staffing agency dedicated to boosting the economic efficiency of US companies. We provide access to a diverse range of skilled Latin American professionals, allowing businesses to build robust teams without the traditional high costs associated with domestic hiring. Our model supports companies in maximizing their resources, driving innovation, and achieving sustainable growth.

The Director of Process Development is responsible for leading and overseeing the creation, optimization, and implementation of new processes within an organization. This role involves strategizing to enhance efficiency, quality, and performance across various departments. The Director collaborates with cross-functional teams to ensure that processes align with business goals and regulatory standards. Additionally, they monitor industry trends and technological advancements to keep the company competitive. By fostering innovation and continuous improvement, the Director of Process Development plays a crucial role in driving the organization's long-term success and sustainability.

- Master's degree or Ph.D. in Chemical Engineering, Biochemistry, Biotechnology, or a related field
- Minimum of 10 years of experience in process development within the pharmaceutical, biotechnology, or a related industry
- Demonstrated experience in leading and managing a team of scientists and engineers
- Strong knowledge of manufacturing processes, process validation, and scale-up techniques
- Proven track record of successful project management, including timeline and budget management
- Comprehensive understanding of industry standards and regulatory requirements (e.g., FDA, EMA)
- Proficiency in data analysis and process optimization methodologies
- Excellent problem-solving skills and the ability to troubleshoot complex process issues
- Strong leadership and mentoring skills
- Exceptional communication and collaboration abilities
- Experience with risk assessment and process control strategies
- Familiarity with current technological advancements and best practices in process development
- Ability to develop and maintain standard operating procedures (SOPs)
- Experience in equipment and materials sourcing and vendor management
- Strong documentation and reporting skills
- Dedication to continuous improvement and operational excellence
- Strategic planning and alignment of process development goals with organizational objectives
- Ability to work in a fast-paced, dynamic environment and manage multiple projects simultaneously

- Oversee and manage all process development activities and projects
- Design, implement, and optimize manufacturing processes
- Lead and mentor process development team members
- Collaborate with cross-functional teams to ensure cohesive project execution
- Conduct and review risk assessments and ensure regulatory compliance
- Develop and manage project timelines, resource allocation, and budgets
- Analyze process data and identify improvement areas
- Develop and implement effective process control strategies
- Review and approve process validation and qualification protocols
- Troubleshoot and resolve process issues, implementing corrective actions
- Report project status, progress, and risks to senior management
- Stay updated on technological advancements and industry best practices
- Develop and maintain standard operating procedures (SOPs)
- Ensure efficient scale-up of new processes from pilot to full production
- Interface with vendors and external partners for equipment and materials sourcing
- Maintain thorough documentation of all process development activities
- Drive continuous improvement initiatives for cost reduction and quality enhancement
- Engage in strategic planning to align process development goals with organizational objectives

The ideal candidate for the role of Director of Process Development will be an accomplished leader with a Master's degree or Ph.D. in Chemical Engineering, Biochemistry, Biotechnology, or a related field, backed by at least 10 years of industry experience, specifically within pharmaceuticals or biotechnology. They will possess proven expertise in managing and mentoring a team of process development scientists and engineers, demonstrating robust leadership, strategic planning, and project management skills. This candidate will showcase a deep understanding of manufacturing processes, process validation, and scale-up techniques, with a comprehensive knowledge of industry standards and regulatory requirements such as FDA and EMA. Their proficiency in data analysis and process optimization will be matched by their exceptional problem-solving capabilities and technical acumen. The ideal candidate will exhibit strong communication abilities, capable of excellent collaboration with cross-functional teams, and bringing innovative solutions to the table. Their commitment to quality and compliance, coupled with a dedication to continuous improvement and operational excellence, will set them apart. They will be highly organized, able to manage multiple projects effectively, and have a proactive, results-oriented approach. With strong negotiating and vendor management skills, they will effectively source equipment and materials to support process development activities. Their high level of integrity, adaptability in a fast-paced environment, and the ability to inspire and mentor their team will make them an invaluable asset to the organization.

- Oversee and manage all process development activities and projects.
- Design, implement, and optimize manufacturing processes to improve efficiency and quality.
- Lead a team of process development scientists and engineers.
- Collaborate with cross-functional teams including R&D, manufacturing, quality assurance, and regulatory affairs.
- Conduct risk assessments and ensure compliance with industry standards and regulations.
- Develop project timelines, allocate resources, and ensure adherence to schedules and budgets.
- Analyze process data and trends to identify areas for improvement.
- Develop and implement process control strategies.
- Review and approve process validation and qualification protocols.
- Troubleshoot process issues and implement corrective actions.
- Report on project status, progress, and potential risks to senior management.
- Stay current with technological advancements and industry best practices.
- Develop and maintain standard operating procedures (SOPs).
- Mentor and train team members on best practices and new techniques.
- Ensure efficient scale-up of new processes from pilot to full production.
- Interface with vendors and external partners to source equipment and materials.
- Maintain thorough documentation of all process development activities and findings.
- Drive continuous improvement initiatives focused on cost reduction and product quality enhancement.
- Engage in strategic planning to align process development goals with organizational objectives.

- Strong leadership and management skills
- Strategic and analytical thinking
- Excellent problem-solving abilities
- High level of technical proficiency in process development
- Effective communication and interpersonal skills
- Ability to mentor and inspire a team
- Strong attention to detail
- Adaptability in a fast-paced environment
- Strong commitment to quality and compliance
- Highly organized with excellent project management skills
- Innovative mindset with a drive for continuous improvement
- Collaborative approach to working with cross-functional teams
- Proactive and results-oriented
- Strong decision-making capabilities
- Ability to manage and prioritize multiple projects
- Dedication to achieving operational excellence
- High level of integrity and professionalism
- Strong negotiating and vendor management skills
- Effective in strategic planning and execution
- Commitment to staying current with industry trends and advancements

- Competitive salary range of $150,000 to $200,000, depending on experience and qualifications
- Comprehensive health benefits, including medical, dental, and vision insurance
- Retirement savings plan with employer matching contributions
- Flexible work schedule with options for remote work
- Generous paid time off (PTO) and holidays
- Professional development opportunities, including training programs and conferences
- Tuition reimbursement for relevant courses and certifications
- Employee wellness programs, including gym memberships and mental health resources
- Stock options or equity participation plans
- Performance-based bonuses and incentives
- Relocation assistance for eligible candidates
- Company-sponsored events and team-building activities
- Paid parental leave and family-friendly policies
- Life and disability insurance
- Employee assistance programs (EAP)
- Opportunities for career growth and advancement within the company
- Collaborative and inclusive work environment
- Access to cutting-edge technology and state-of-the-art facilities
- Recognition and reward programs for outstanding performance
- Company car or transportation allowance for senior roles