Job DescriptionThe Head of BioTechnique 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 BioTechnique 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 resource recommendations to the CEO for alignment and approvals.
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
- Demonstrate organization P&L meets the goals and fully aligned with overall company business strategies
- Review budgets, monitor expenses, and optimize resource allocation.
- Support growth initiatives through disciplined operational execution, maintaining product quality and safety.
- Collaborate with finance and accounting teams to achieve financial goals.
Leadership, Talent & Organizational Readiness
- Demonstrated ability to build a high-performing manufacturing organization by developing talent, 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 that align with site capabilities, capacity, and strategic growth objectives.
- 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.
BenefitsOffering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
- Medical, Dental, and Vision - PSC pays 100% of all 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
- PTO, Sick Time, and Paid Holidays
- Education Assistance
- Pet Insurance
- Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more)
- Financial Perks and Discounts
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