Okay, I've searched for Director roles in upstream process development located in Madison, WI within the biopharmaceutical industry, for full-time positions requiring 12+ years of experience and leadership expertise. I have found 42 positions for you.

Sure. Here's the analysis:

Job Analysis:

The Director of Upstream Process Development at Catalent is fundamentally hired to lead and advance the technical and strategic facets of cell culture process development for biologics manufacturing. This senior role demands deep scientific expertise in mammalian cell culture methods—particularly in developing scalable, reproducible, and efficient upstream processes for therapeutic proteins—coupled with strong leadership capabilities to guide a multidisciplinary team. The candidate will confront challenges such as optimizing complex bioreactor parameters, managing technology transfers to GMP production, maintaining rigorous compliance with global regulatory frameworks, and balancing competing priorities across multiple client projects. Success here requires not only mastery of technical tools like Design of Experiments (DoE), process analytical technologies, and single-use bioreactors, but also exceptional communication skills to translate complex scientific progress into actionable insights for clients and internal stakeholders. The role involves high autonomy and cross-functional collaboration, where the Director acts as both a subject matter expert and a strategic leader, driving innovation while ensuring timelines, budgets, and quality targets are met. The ability to navigate ambiguity, lead difficult technical conversations, and maintain focus under pressure is paramount. In the first 6–12 months, success would look like establishing robust process development pipelines, strengthening team capabilities, initiating or improving tech transfer protocols, and affirming client confidence through transparent, impactful technical leadership.

Company Analysis:

Catalent operates as a global CDMO powerhouse committed to accelerating drug development and manufacturing across pharma, biotech, and consumer health sectors. Its role as a market leader and innovator, empowered by expansive resources (40+ global sites and thousands of experts), sets a high bar for quality, scalability, and technological sophistication. The company’s culture emphasizes patient-first values, quality excellence, and compliance, which shapes the work environment as fast-paced yet mission-driven, requiring individuals who are both dynamic and detail-oriented. Catalent's Madison facility’s focus on cutting-edge single-use system biomanufacturing and integrated formulation/analytical services signals a technologically advanced, innovation-forward workplace. The Director role sits at a pivotal nexus within this complex organization, bridging research, development, manufacturing, quality assurance, and client services, indicating significant organizational visibility and influence. Given Catalent’s strategic growth priorities and commitment to launching numerous new products annually, this role is a critical growth and innovation driver, accountable for ensuring upstream processes not only support but speed product commercialization. The candidate must resonate with Catalent’s values of collaboration, accountability, and patient impact while thriving in a culture that values leadership development and continuous improvement.

Absolutely. Here are some mock interview questions that could come up:

• Behavioral: Tell me about a time when you had to lead a team through a challenging bioprocess development project under tight deadlines. How did you ensure both scientific rigor and timely delivery?
• Behavioral: Describe an instance where you had to communicate complex upstream process challenges to a non-technical client. What strategies did you use to ensure clarity and partnership?
• Behavioral: Can you share an experience where you faced conflicting priorities between client demands and regulatory compliance? How did you resolve it?
• Behavioral: Give an example of how you mentored a junior scientist or engineer to improve their technical or leadership skills. What was the outcome?
• Technical: How do you approach the design and execution of a Design of Experiments (DoE) study to optimize cell culture conditions for a new biologic candidate?
• Technical: What key parameters and considerations do you focus on when scaling up mammalian cell culture processes from bench to commercial scale?
• Technical: Explain how you would integrate advanced upstream technologies such as perfusion or continuous processing into an existing biomanufacturing pipeline.
• Technical: How have you ensured successful tech transfer of upstream processes into cGMP manufacturing environments in your previous roles?
• Situational: Imagine a situation where a newly developed upstream process is producing inconsistent product quality at pilot scale. How would you identify and resolve the root cause?
• Situational: Suppose a client requests a significant change late in the process development timeline that could impact regulatory submissions. How would you manage this request with your team and the client?
• Situational: If two cross-functional teams disagree on critical process parameters needed for manufacturing scale-up, how would you facilitate a resolution?
• Company Fit: What attracts you to Catalent and this role in particular, considering our mission and global presence?
• Company Fit: How do your personal values align with Catalent’s patient-first culture and commitment to quality and compliance?
• Company Fit: How do you handle the challenge of working in a dynamic, fast-paced environment while maintaining high standards of scientific and operational excellence?
• Questions for Interviewer: How does Catalent measure success for the Director of Upstream Process Development in the first year?
• Questions for Interviewer: Could you describe how this role collaborates with other departments such as manufacturing, quality, and business development?
• Questions for Interviewer: What are the company's current priorities or upcoming challenges for the Madison facility, and how would this role contribute to addressing them?