Okay, I've searched for Director-level Small Molecule Process Development roles in Thousand Oaks, CA, full-time positions within the pharmaceutical or biotech industry, requiring 10+ years of experience and leadership capabilities. I have found several relevant positions for you.

Sure. Here's the analysis:

Job Analysis:

The Director of Small Molecule Process Development at Amgen is a senior leadership role that centers on advancing robust, scalable drug substance manufacturing processes from research through commercialization for a broad synthetic portfolio, including small molecules and hybrid modalities like peptides and oligonucleotides. This role demands a deep technical expertise in synthetic organic chemistry, process development, regulatory compliance (GLP, GMP, ICH), and technology transfer. The candidate is expected not only to lead scientific innovation and operational execution but also to manage a team, develop future leaders, and align resources with organizational priorities. The role requires navigating complex scientific challenges, driving process optimization for regulatory submissions and manufacturing readiness, and maintaining cutting-edge awareness of industry trends and regulatory environments. Success here means delivering scalable, compliant processes that accelerate product launch timelines, building high-performing teams, and effectively collaborating cross-functionally across R&D, manufacturing, quality, and regulatory bodies, both internally and with external partners. The candidate will need strong decision-making autonomy while balancing multiple competing priorities and ensuring clear communication at all organizational levels.

Company Analysis:

Amgen is a pioneering biotech leader with a mission-driven culture focused on serving patients by developing innovative therapies in oncology, inflammation, general medicine, and rare diseases. This focus on serious illnesses and scientific innovation creates an environment that values collaboration, scientific rigor, and adaptability amid the evolving biotech landscape. The culture is award-winning, emphasizing continuous learning, inclusivity, and a commitment to impact, which means the Director must thrive in a fast-paced, mission-oriented setting that blends rigorous science with cross-functional teamwork. Positioned as both a market leader and innovator, Amgen supports employees with competitive benefits and career development opportunities, signaling a stable yet dynamic workplace. The Director role sits within a critical technical function, reporting to senior leadership, offering significant visibility and influence on upstream drug substance development and manufacturing strategy, and serving as a key contributor to Amgen's pipeline delivery. This alignment underlines the strategic importance of the position in scaling complex manufacturing processes to meet clinical and commercial demands while fostering scientific excellence within the team.

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

• Behavioral: Tell me about a time you had to lead a small molecule process development project under tight timelines. How did you prioritize and manage team resources?
• Behavioral: Describe how you have developed and coached junior scientists or process chemists to prepare them for leadership roles.
• Behavioral: Give an example of how you handled a significant cross-functional disagreement during a technology transfer or scale-up initiative.
• Behavioral: Share an experience where you had to adapt quickly to changing project priorities or unexpected regulatory challenges.
• Technical: Can you explain your approach to designing and optimizing a commercial synthetic process for a complex small molecule?
• Technical: How do you ensure compliance with GLP/GMP standards throughout process development and scale-up activities?
• Technical: What strategies do you use to integrate process characterization data into regulatory submissions like IND or NDA applications?
• Technical: Describe your experience leading technology transfers across internal or external manufacturing sites. What are key challenges and how do you mitigate them?
• Situational: Imagine one of your commercial process development projects faces unexpected impurities that jeopardize regulatory approval. How would you address this issue while maintaining timelines?
• Situational: If your team is struggling with cohesion and communication, what steps would you take to foster a collaborative and productive environment?
• Situational: Suppose senior management requests faster development timelines that may pressure quality or documentation rigor. How do you balance these demands?
• Company Fit/Motivation: What attracts you to Amgen’s mission and how does your professional philosophy align with serving patients through innovative biotech solutions?
• Company Fit/Motivation: How do you see yourself contributing to Amgen’s collaborative culture and advancing its drug substance technologies portfolio?
• Company Fit/Motivation: Given Amgen’s focus on inclusion and diversity, how have you fostered these values within your previous teams?
• Questions for Interviewer: How does this role interact with other departments like Quality, Regulatory Affairs, and Commercial Manufacturing on a day-to-day basis?
• Questions for Interviewer: What are the biggest current challenges facing the Small Molecule Process Development team, and what would success look like in the first year for this Director?
• Questions for Interviewer: How does Amgen support ongoing professional development and innovation within its Process Development leadership?