Head of BioTechnique

Head Of Bio Technique

Bio Technique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we provide formulation and compounding, fill-finish, and lyophilization services for a wide variety of liquid injectables. Bio Technique utilizes our team's expertise to create a process design for our clients' products that best suits their needs. The Experience With operations spanning the globe and featuring a multi-cultural team, Bio Technique is passionate about bringing the best and brightest together in an effort to form something truly special.

When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered a compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At Bio Technique, it's about more than just a job—it's about your career and your future.

Your Role The Head of Bio Technique will play a critical role in overseeing the end-to-end operational performance across manufacturing, quality, supply chain, logistics, and customer-facing execution. This role ensures continuous state of inspection readiness, consistent regulatory compliance, and reliable delivery to customers. Reporting to the CEO, the Head of Bio Technique Operations translates strategic objectives into disciplined, execution-ready operating models that support growth while meeting the highest standards of quality, safety, and compliance.

Operational Leadership & Execution Align policies and procedures related to drug manufacturing, warehousing, logistics, and supply chain management with business growth, scalability, and operational performance. Establish standardized, scalable operating models that support reliable execution, capacity planning, and on-time delivery Develop and implement strategies to optimize production processes, quality control, and inventory management. Collaborate with department heads to ensure seamless coordination across all functions.

Audit Readiness, Quality & Compliance Maintain continuous state of GMP and regulatory inspection readiness across all operational areas. Work closely with Quality Assurance to ensure adherence to 21 CFR Parts 210/211, FDA, and applicable global regulatory requirements. Monitor changes in regulations and adapt processes accordingly Lead operational responses to regulatory inspections, customer audits, and quality events, ensuring timely and effective remediation.

Implement and sustain robust quality systems, deviation management, CAPAs, risk assessments, and change control in operations.

Customer & Business Support Serve as a senior operational interface for customers, supporting audits, performance reviews, issue resolution, and continuous improvement initiatives Ensure customer commitments related to quality, service levels, timelines, and cost are consistently met or exceeded. Align operational capabilities with customer onboarding and lifecycle management requirements. Build strong relationships with clients, suppliers, and partners. Represent the organization in industry forums, conferences, and networking events.

Operational Excellence & Continuous Improvement Leverage lean, digitalization, risk based and automation to improve efficiency and reliability. Drive continuous improvement initiatives using data, KPIs, and performance metrics focused on quality, delivery, cost, and compliance. Report performance to executive leadership. Foster a culture of accountability, standard work, and right-first-time execution Capacity, Capital & Infrastructure Planning Ability to establish capacity planning & capital investments, including facility expansion, equipment, and workforce scaling to meet demands.

Perform consistent and effective analysis, and present data-driven investment and…