The Role
Leads end-to-end CDMO operations across sterile injectable manufacturing, quality, supply chain, logistics, customer execution, and business development. Ensures GMP and regulatory inspection readiness, operational scalability, capacity planning, continuous improvement, risk mitigation, business continuity, and P&L performance. Partners with customers, suppliers, department heads, and the CEO to achieve reliable delivery, quality, compliance, financial targets, and sustainable growth while building a high-performing manufacturing organization.
Summary Generated by Built In
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 provide formulation and compounding, fill-finish, and lyophilization services for a wide variety of liquid injectables. BioTechnique 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, BioTechnique 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 BioTechnique, it’s about more than just a job—it’s about your career and your future.
Your Role
The 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.
Benefits
Offering 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
Equal Opportunity Employment Statement
PSC is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.
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Skills Required
- Bachelor's degree in a relevant field such as Business Administration, Engineering, or Pharmacy
- Proven experience as Head of Operations or in a 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
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The Company
What We Do
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support. To date, PSC Biotech Corporation now serves 1000 clients in more than 35 countries worldwide through professional services consulting, cloud-based software solutions, pharmaceuticals contract manufacturing, life science investment consulting, and metrology services. PSC Biotech Corporation has six unique divisions within the parent company – each representing one of our areas of expertise: PSC Biotech, PSC Software, BioTechnique™, PSC Partners, PSC Metrology and PSC Investments. Additionally, PSC Asia and PSC Biotech Ltd represent PSC Biotech Corporation in Asia and Europe, respectively. Together, these divisions enable us to meet the ever-changing needs of our clients with a commitment to excellence and superior quality.
