Associate Director, Drug Product Manufacturing

Job Description

Promega is seeking a visionary and mission-driven Director of Drug Product Manufacturing to architect and lead our in-house, FDA-compliant encapsulation, bottling, and packaging capabilities. This role is a transformational leadership opportunity-establishing Promega as a center of excellence in oral solid dose manufacturing, beginning with psilocybin-based therapies and expanding to other emerging small molecules.

This leader will shape both infrastructure and culture-designing future-ready, tech-integrated GMP systems that embody our operational values and support long-term therapeutic access through Usona. A critical component of this role will involve the strategic application of AI, not as a buzzword, but as a pragmatic tool to optimize manufacturing, strengthen quality systems, and ensure inspection readiness.

This is a rare opportunity to build something foundational and lasting-a model of modern, digitally enabled drug product operations that reflects the integrity and innovation at the heart of Promega and Usona.

JOB OBJECTIVE : The Associate Director, Drug Product Manufacturing will architect and lead our in-house, FDA-compliant encapsulation, bottling, and packaging capabilities. This leader will shape both infrastructure and culture-designing future-ready, tech-integrated GMP systems that embody our operational values and support long-term therapeutic access through Usona. A critical component of this role will involve the strategic application of AI as a pragmatic tool to optimize manufacturing, strengthen quality systems, and ensure inspection readiness.

CORE DUTIES :

1. Lead and execute the strategy for in-house drug product manufacturing, focused on scalability, compliance, and speed-to-readiness.

2. Serve as technical and operational lead for facility design, cleanroom layout, and GMP flow optimization.

3. Create and maintain detailed project plans, timelines, and budgets.

4. Select and qualify equipment (e.g., capsule fillers, bottling systems, blister packaging), with attention to both current and future therapeutic needs.

5. Oversee commissioning, qualification (IQ / OQ / PQ), process validation, and PPQ batches to support NDA filings.

6. Contribute to CMC content, coordinate submission-ready documentation, and collaborate with regulatory on dossier content.

7. Integrate AI tools into daily operations-for predictive maintenance, deviation trending, and continuous process verification.

8. Implement and steward data management and data governance frameworks that ensure all Drug Product Manufacturing data is captured with high-quality metadata, structured for machine actionability, and maintained according to FAIR principles (Findable, Accessible, Interoperable, Reusable).

9. Lead technology transfer from CDMOs, focusing on digital capture of process knowledge and seamless scale-up.

10. Hire and develop a cross-functional team spanning drug product ops, formulation, validation, and QA.

11. Facilitate cross-departmental communication specifically around risks and mitigation strategies.

12. Collaborate with IT, Engineering, and Quality to deploy MES, eBRs, and data-integrity-compliant systems.

13. Partner with Promega Quality, IT, and Operations to design and implement drug-product systems that integrate with our Quality Management System and digital infrastructure.

14. Manage risk in development and transfer projects using structured risk management techniques.

15. Ensure cGMP, DEA, and ISO13485 compliance across all processes; act as SME during regulatory inspections.

16. Oversee process safety evaluations for drug product operations, including handling of excipients and residual API.

17. Collaborate with Analytical Development and Quality Control teams to transfer and verify analytical methods.

18. Apply Quality by Design (QbD) principles to formulation and process development.

19. Embed continuous learning, digital curiosity, and collaborative innovation into team culture.

20. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.

21. Embracing and being open to incorporating Promega's 6 Emotional & Social Intelligence (ESI) core principles in daily work.

22. Understands and complies with ethical, legal and regulatory requirements applicable to our business.

KEY QUALIFICATIONS :

1. Bachelor's or advanced degree in Engineering, Life Sciences, Pharmacy, or related field.

2. 10+ years of leadership in FDA-regulated drug product manufacturing (oral solid dose required).

3. End-to-end experience with encapsulation, bottling, and validation of manufacturing systems.

4. Familiarity with capsule-filling platforms such as Harro Hofliger or equivalents.

5. Demonstrated ability to apply AI and digital tools to real-world manufacturing challenges.

6. Proven success in tech transfer, team leadership, and GMP inspection preparedness.

7. Proficient in operating a computer and phone, using Microsoft Office applications, and adapting to emerging technologies relevant to the role.

PREFERRED QUALIFICATIONS :

1. Experience with blister packaging, particularly for EU / EMA markets.

2. Track record working with controlled substances and DEA-licensed operations.

3. Leadership in greenfield or facility expansion projects.

4. Proficiency with MES, eBRs, and quality-driven automation tools.

PHYSICAL DEMANDS :

1. Ability to stand, walk, bend, and lift up to 25 lbs.

2. Must be able to work in cleanroom environments for extended periods.

3. Personal Protective Equipment (PPE), including gowning, gloves, masks, and eye protection, may be required depending on task-specific needs.

4. May require occasional evening or weekend work to support operational readiness or validation timelines.

At Promega, we are committed to building a diverse workforce that reflects the communities we serve and creating a culture where everyone belongs. As an Equal Opportunity Employer, we welcome and encourage applications from all backgrounds, ensuring that employment decisions are made fairly and equitably.