Head of BioTechnique

About the Company

BioTechnique is a sterile injectable full-service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we offer formulation and compounding, fill-finish, and lyophilization services for a wide variety of liquid injectables. BioTechnique leverages our team’s expertise to create process designs tailored to our clients’ needs.

With operations spanning the globe and a multicultural team, BioTechnique is passionate about bringing together the best talent to form something truly special. We believe in coaching and developing the next generation of industry leaders, offering tools for growth and a supportive environment to nurture your career and future.

About the Role

The Head of BioTechnique will oversee end-to-end operational performance across manufacturing, quality, supply chain, logistics, and customer-facing execution. This role ensures continuous inspection readiness, regulatory compliance, and reliable delivery to customers. Reporting to the CEO, you will translate strategic objectives into disciplined, execution-ready operating models that support growth while meeting the highest standards of quality, safety, and compliance.

Responsibilities

• Operational Leadership & Execution: Align policies and procedures for drug manufacturing, warehousing, logistics, and supply chain with business growth and scalability. Establish standardized, scalable operating models to 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 GMP and regulatory inspection readiness. Work closely with Quality Assurance to ensure adherence to 21 CFR Parts 210/211, FDA, and global regulatory requirements. Monitor regulatory changes and adapt processes accordingly. Lead operational responses to regulatory inspections, customer audits, and quality events, ensuring timely remediation. Implement and sustain robust quality systems, deviation management, CAPAs, risk assessments, and change control.
• 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. 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 approaches, and automation to improve efficiency and reliability. Drive continuous improvement 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: Establish capacity planning and capital investments, including facility expansion, equipment, and workforce scaling to meet demands. Perform analysis and present data-driven investment and resource recommendations to the CEO for alignment and approval.
• Risk Management & Business Continuity: Identify, assess, and mitigate operational risks including quality, EHS, cybersecurity, and supply chain continuity. Ensure robust business continuity and contingency plans are in place to protect customer supply.
• Financial & P&L Accountability: Ensure the organization’s P&L meets goals and aligns with overall company business strategies. Review budgets, monitor expenses, and optimize resource allocation. Support growth initiatives through disciplined operational execution while maintaining product quality and safety. Collaborate with finance and accounting teams to achieve financial goals.
• Leadership, Talent & Organizational Readiness: Build a high-performing manufacturing organization by developing talent and strengthening technical and leadership capabilities. Drive a culture of training, accountability, and continuous improvement.
• Business Development: Lead business development for the site by identifying, pursuing, and securing new clients and product opportunities aligned with site capabilities and strategic growth objectives. Demonstrate strong commercial and client-partnership leadership to build a qualified pipeline, shape winning proposals, negotiate value-based agreements, and convert opportunities into sustainable, long-term revenue.

Requirements

• Bachelor’s degree in a relevant field (e.g., Business Administration, Engineering, Pharmacy).
• Proven experience as Head of Operations or similar leadership role in pharmaceutical manufacturing.
• Strong understanding of sterile injectables, logistics, and drug development.
• Familiarity with digital technologies, data analytics, and Industry 4.0 concepts.
• Excellent communication, negotiation, and problem-solving skills.
• Ability to thrive in a fast-paced, dynamic environment.

Benefits

• Medical, Dental, and Vision: PSC pays 100% of qualifying employee medical premiums and 50% for qualifying dependents.
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability, and more.
• 401(k) and 401(k) matching.
• Paid Time Off: PTO, sick time, and paid holidays.
• Education Assistance.
• Pet Insurance.
• Fitness Benefits: Membership discounts and perks at qualifying gyms (e.g., Anytime Fitness, 24-Hour Fitness).
• Financial Perks and Discounts.