Kailera

Associate Director, Manufacturing and Development (Oral)

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Associate Director, Pharmacovigilance Scientist

The Associate Director, Drug Product at Kailera will lead drug product activities with external partners, focusing on manufacturing process development, clinical supply manufacture, and commercial preparedness for oral solid dosage forms. This role requires a strong understanding of drug product development throughout clinical stages. Key responsibilities include selecting and managing CDMOs, coordinating technology transfer, optimizing formulation and processes, and ensuring the quality and regulatory compliance of projects. The individual will collaborate extensively with internal cross-functional teams to advance novel therapies for obesity and related conditions, contributing to Kailera's mission to transform lives.

Senior Medical Director, Pharmacovigilance

<p class="my-4 text-gray-700 leading-relaxed">At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.</p><p class="my-4 text-gray-700 leading-relaxed">We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.</p><h3 class="text-xl md:text-2xl font-bold mt-8 mb-3 text-gray-800">What You’ll Do:</h3><p class="my-4 text-gray-700 leading-relaxed">The Associate Director, Drug Product will support drug product activities with external partners including manufacturing process development and optimization, clinical supply manufacture and commercial preparedness with a focus on oral solid dosage forms. The individual will have a working knowledge of drug product development throughout clinical development.</p><p class="my-4 text-gray-700 leading-relaxed"><em>Required location: San Diego, CA (onsite or hybrid 2-3 days per week).</em></p><h3 class="text-xl md:text-2xl font-bold mt-8 mb-3 text-gray-800">Responsibilities:</h3><ul class="list-disc list-inside my-5 pl-5 space-y-2 text-gray-700"><li class="leading-relaxed">Contribute to the selection, engagement, and management of CDMO’s, including assessment of capabilities, drafting requests for proposals, and providing recommendations based on selection criteria</li><li class="leading-relaxed">Coordinate technology transfer, formulation and process development, optimization, scale-up and manufacturing of clinical supplies, acting as Kailera’s person-in-plant for activities critical to program success</li><li class="leading-relaxed">Collaborate closely with internal cross-functional teams, including Drug Substance, Analytical Development, Supply Chain, Clinical, Quality Assurance, and Regulatory Affairs to ensure seamless progression of projects</li><li class="leading-relaxed">Review master batch records and executed batch records to ensure product quality</li><li class="leading-relaxed">Manage cGMP change controls and manufacturing deviations as necessary, working closely with Kailera’s quality group</li><li class="leading-relaxed">Lead initiatives to enhance manufacturing efficiency, reduce costs and improve product quality through experimental design with a focus on commercial preparedness</li><li class="leading-relaxed">Author, review, and update CMC specific documents to support worldwide regulatory submissions (i.e., IND, IMPD and NDA)</li></ul><h3 class="text-xl md:text-2xl font-bold mt-8 mb-3 text-gray-800">Required Qualifications:</h3><ul class="list-disc list-inside my-5 pl-5 space-y-2 text-gray-700"><li class="leading-relaxed">10+ years of experience in the pharmaceutical industry with a proven track record of technical expertise in unit operations common to solid oral dosage form (e.g., dry granulation, compression and film-coating)</li><li class="leading-relaxed">Extensive experience with management and oversight of activities at CDMO’s</li><li class="leading-relaxed">Strong troubleshooting skills with the ability to quickly provide input in a fast-paced environment</li><li class="leading-relaxed">Strong working knowledge of Excel, Word, PowerPoint</li><li class="leading-relaxed">Experience drafting CMC documents for regulatory filings</li><li class="leading-relaxed">Experience using quality systems such as Veeva to author and approve documents</li><li class="leading-relaxed">Excellent verbal, written and interpersonal skills</li><li class="leading-relaxed">Innovative team-player capable of working cross-functionally to achieve program goals</li><li class="leading-relaxed">Ability to travel up to 20% (domestic and international)</li></ul><h3 class="text-xl md:text-2xl font-bold mt-8 mb-3 text-gray-800">Preferred Qualifications:</h3><ul class="list-disc list-inside my-5 pl-5 space-y-2 text-gray-700"><li class="leading-relaxed">Experience in the GLP-1 space</li></ul><h3 class="text-xl md:text-2xl font-bold mt-8 mb-3 text-gray-800">Education:</h3><ul class="list-disc list-inside my-5 pl-5 space-y-2 text-gray-700"><li class="leading-relaxed">Bachelors Degree in Engineering, Pharmaceutical Sciences, Life Sciences or closely related field</li></ul><h3 class="text-xl md:text-2xl font-bold mt-8 mb-3 text-gray-800">Benefits of Working at Kailera</h3><p class="my-4 text-gray-700 leading-relaxed">In addition to traditional benefits, we provide enhanced offerings designed to support the well-being and financial security of our team members and their families.</p><ul class="list-disc list-inside my-5 pl-5 space-y-2 text-gray-700"><li class="leading-relaxed">Comprehensive health benefits and tax-advantaged savings accounts</li><li class="leading-relaxed">Flexible time off, 13 paid holidays, and a companywide year-end shutdown</li><li class="leading-relaxed">Monthly wellness stipend</li><li class="leading-relaxed">Generous 401(k) match</li><li class="leading-relaxed">Disability and life insurance</li></ul>

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Go guardian

Manager, Safety Support Specialists

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GoGuardian is seeking a passionate Manager, Safety Support Specialists to lead a 24/7 team of approximately 20 specialists. This critical role involves monitoring, evaluating, and responding to alerts related to student well-being, ensuring the safety of students. The manager will drive operational rigor with empathy, balancing human-centered decision-making with business judgment and legal understanding. Responsibilities include hiring, performance management, process improvement, and partnering with customers to enhance alerting systems and product experience, while also serving as an on-call escalation point.

At GoGuardian, we’re helping shape the future of digital learning by providing educators, students, and schools with tools to create equitable and engaging learning environments. Together, we build innovative solutions that empower students, deliver insights, encourage experimentation, and reduce inequity.We’re looking for passionate team members to join us!

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<h2 class="text-2xl md:text-3xl font-bold mt-10 mb-4 border-b pb-2 text-gray-800">What We Do</h2><p class="my-4 text-gray-700 leading-relaxed">At GoGuardian, we’re helping build a future where all learners are ready and inspired to solve the world’s greatest challenges. Our award-winning system of learning solutions is purpose-built for K-12 and trusted by school leaders to promote effective teaching and equitable engagement while helping empower educators to keep students safe.</p><h2 class="text-2xl md:text-3xl font-bold mt-10 mb-4 border-b pb-2 text-gray-800">What It’s Like to Work at GoGuardian</h2><p class="my-4 text-gray-700 leading-relaxed">We are an outcomes-focused learning company with a steadfast focus on improving learning environments, one classroom at a time. Working with us means joining a remote team of diverse, committed, mission-driven employees who are inspired by our vision, dedicated to our customers, and ready to roll up their sleeves. Guardians put their heads together to solve problems, learn together from experiments that fail, and stand together by their work with full accountability. We balance our diligence with an inclusive culture that invites everyone to bring their whole self to work. Join us and learn why “I love the people here” is one of the most frequent comments we hear from Guardians.</p><h2 class="text-2xl md:text-3xl font-bold mt-10 mb-4 border-b pb-2 text-gray-800">The Role</h2><p class="my-4 text-gray-700 leading-relaxed">We’re looking for a passionate, driven individual to be our Manager of the Safety Support Specialist team. This role carries the critical responsibility of leading a team of specialists who monitor, evaluate, and respond to alerts related to student well-being. You’ll manage a team of about 20 individuals supporting our customers 24 hours a day, 7 days a week, ensuring the safety of their students.</p><p class="my-4 text-gray-700 leading-relaxed">In this role, you’ll be responsible for driving operational rigor while leading with deep empathy for your team, our customers, and the students we serve. You’ll balance compassionate, human-centered decision-making with sound business judgment and a strong understanding of legal and policy frameworks. This position sits within Professional Services and Customer Success organization, which ensures our customers are fully supported and aligned toward our shared outcomes.</p><p class="my-4 text-gray-700 leading-relaxed">The ideal candidate cares deeply about students, educators, and the role our school systems play in supporting youth. They bring experience in building operational excellence without losing sight of empathy and ethical leadership. They understand how to make thoughtful decisions that balance emotional, operational, and legal perspectives especially in sensitive or high-stakes situations involving student safety.</p><p class="my-4 text-gray-700 leading-relaxed">This role requires a strong, self-led leader with experience managing teams, particularly in school or youth-focused environments that emphasize social-emotional well being. The leader will collaborate closely with cross-functional partners within the Customer Support organization, driving key performance indicators to ensure consistency, impact, and effectiveness in protecting students across the nation.</p><p class="my-4 text-gray-700 leading-relaxed">Because this team operates 24/7, this leader will also serve as an escalation point outside of normal business hours, including during on-call periods.</p><h2 class="text-2xl md:text-3xl font-bold mt-10 mb-4 border-b pb-2 text-gray-800">What You'll Do</h2><ul class="list-disc list-inside my-5 pl-5 space-y-2 text-gray-700"><li class="leading-relaxed">Hire, recruit and lead a high-performing team of Safety Support Specialists focused on monitoring, evaluating and responding to alerts from our Beacon product. This includes ensuring highly auditable support processes and operations that enable the success of each team member and the team overall.</li><li class="leading-relaxed">Build scalable solutions and process-driven approaches that do not rely on Standards of Practice that support the team and the cross-functional partner teams.</li><li class="leading-relaxed">Manage and evaluate the performance of each team-member to ensure they are performing against the most important Key Performance Indicators and accelerating toward the mutual goals of the individual and the company.</li><li class="leading-relaxed">Monitor, evaluate and understand the digital products that support your team and our Beacon product supporting our customers to identify opportunities for improvement and higher impact.</li><li class="leading-relaxed">Drive a spirit of continuous improvement, always looking for ways we can increase productivity, build better scalable systems and best support our customers in an effort to drive more impact by preventing self harm, threats and violence within our customers’ schools.</li><li class="leading-relaxed">Partner with customers to represent the needs of our customers, tracking trends within K–12 environments, evaluating customer feedback on our processes, and surfacing opportunities to strengthen our alerting systems and product experience.</li></ul><h2 class="text-2xl md:text-3xl font-bold mt-10 mb-4 border-b pb-2 text-gray-800">Who You Are</h2><ul class="list-disc list-inside my-5 pl-5 space-y-2 text-gray-700"><li class="leading-relaxed">An experienced leader who’s managed teams of 15+ members, with 3+ years of experience demonstrating a proven track record to hire, recruit and build high-performing teams.</li><li class="leading-relaxed">A leader who has experience with Customer Support operations, including staffing to demand trends and building contingency planning for customer needs that can spike and retract at times, unexpectedly.</li><li class="leading-relaxed">A compassionate, empathetic person who cares deeply about the safety of the youth in our school systems and has experience working in the social-emotional youth field.</li><li class="leading-relaxed">Eager to take initiative in a fast-paced, ever-changing, dynamic environment and to challenge the status-quo in order to innovate for 10x impact.</li><li class="leading-relaxed">Fueled by the ability to truly drive impact in protecting youth from self-harm and school-violence.</li><li class="leading-relaxed">Emotionally resilient enough to constantly evaluate and discuss these difficult topics.</li></ul><h2 class="text-2xl md:text-3xl font-bold mt-10 mb-4 border-b pb-2 text-gray-800">What We Offer</h2><ul class="list-disc list-inside my-5 pl-5 space-y-2 text-gray-700"><li class="leading-relaxed">Competitive pay, complete health insurance, 401(k) matching, and an employee equity plan.</li><li class="leading-relaxed">Flexible time off, paid holidays, paid parental leave, and a paid year-end holiday break.</li><li class="leading-relaxed">A robust catalog of benefits that support your professional growth and personal wellbeing, including work from home funds, fertility & adoption reimbursement, and more…</li></ul><p class="my-4 text-gray-700 leading-relaxed"><em>Plus the intangible:</em></p><ul class="list-disc list-inside my-5 pl-5 space-y-2 text-gray-700"><li class="leading-relaxed">A varied and challenging role in an innovative, global company.</li><li class="leading-relaxed">Supportive, driven colleagues who have your back and share your passion.</li></ul><p class="my-4 text-gray-700 leading-relaxed">The typical base salary range for this position is $110,000- $115,000 per year. The range displayed on this job posting reflects the minimum and maximum target for new hire base pay for this position and your pay will be determined by a variety of factors, including your primary work location, skills, qualifications and experience. Additional benefits information is listed on our careers page.</p><p class="my-4 text-gray-700 leading-relaxed">Please share this with your friends or co-workers who may be interested in working! We have multiple openings and are always looking for talented people.</p><p class="my-4 text-gray-700 leading-relaxed">is an equal opportunity employer and makes employment decisions on the basis of merit and business needs. does not discriminate against employees, applicants, interns or volunteers on the basis of race, religion, color, national origin, ancestry, physical disability, mental disability, medical condition, pregnancy, marital status, sex, age, sexual orientation, military and veteran status, registered domestic partner status, genetic information, gender, gender identity, gender expression, or any other characteristic protected by applicable law.</p><p class="my-4 text-gray-700 leading-relaxed">Job Applicant Privacy Policy is located <a href="https://www.goguardian.com/policies/job-applicant-privacy-notice" target="_blank" rel="noopener noreferrer" class="text-blue-600 hover:text-blue-800 hover:underline transition-colors duration-200"><strong>here</strong></a></p><p class="my-4 text-gray-700 leading-relaxed">.</p><p class="my-4 text-gray-700 leading-relaxed">#BI-Remote</p>

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This assessment gives us an idea of your C++ skills- Companies that evaluate this skillset in interviews: Rockstar Games, Ubisoft, Mayhem Studios, etc.- 10 Multiple Choice questions- Average time to complete: 7 to 10 minutes

Let's assess your Data Structures! - This assessment gives us an idea of your problem solving skills using DSA- Companies that evaluate this skillset in interviews: MPL, LILA Games, GSN Games, etc.- 10 Multiple Choice questions

Data Structures and Algorithms

Let's assess your Programming Patterns! ????- This assessment gives us an idea of your code architecture skills- Companies that evaluate this skillset in interviews: Dirtcube, PTW, Playshifu, etc.

Programming Patterns

Let's assess your OOPs skills! ????- This assessment gives us an idea of your fundamental OOPS concepts and Solid principles skills- Companies that evaluate this skillset in interviews: Hitwicket, GSN Games, Tomo Club, etc.

Object Oriented Programming

Let's assess your Unity Skills ????- This assessment gives us an idea of your Unity fundamentals- Companies you can apply for after taking this assessment: Godspeed games, Salvation Games, nCore Games, etc.