Source Job

• Own drug substance technology transfer, MSAT, and manufacturing oversight for CDMO partners.
• Lead process validation, commercialization, and lifecycle management for peptide DS manufacturing.
• Build and develop high-performing teams while ensuring cGMP compliance and regulatory readiness.

Kailera Therapeutics is a biopharmaceutical company developing novel therapies for obesity and related conditions. The company fosters an entrepreneurial, team-oriented culture focused on collaboration, integrity, and excellence and is expanding its team.

• Lead CMC workstream planning across multiple development programs, from technical development through regulatory submission.
• Build integrated CMC timelines in Smartsheet and coordinate with CDMO partners on tech transfers and manufacturing.
• Manage risks, budgets, and cross-functional technical operations teams to drive decisions and ensure on-time delivery.

Kailera is a biopharmaceutical company developing novel therapies for obesity and related conditions. It fosters an entrepreneurial, team-oriented culture and is committed to building an inclusive workplace.

• Provide strategic and operational leadership across multiple clinical programs, translating development strategy into strong execution.
• Oversee clinical trial planning, budgets, CRO/vendor relationships, and cross-functional collaboration to ensure quality and accountability.
• Lead and develop a small Clinical Operations team while remaining hands-on in a fast-paced biotech environment.

Deciphera, a member of Ono Pharmaceutical Co., Ltd., is a biopharmaceutical company focused on discovering, developing, and commercializing new medicines for cancer, neurologic, and autoimmune diseases. The company fosters an inclusive culture valuing curiosity, creativity, and shared accountability, empowering employees to drive breakthroughs.

• Leverage pharmaceutical manufacturing expertise and AI knowledge to drive innovation in regulated production environments.
• Assess manufacturing processes, identify bottlenecks, and develop AI-driven solutions for efficiency and compliance.
• Advise senior stakeholders on AI opportunities, regulatory readiness, and implementation strategies.

Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. They use technology to streamline the application process, but the size and culture are not specified.

• Oversee contract development and manufacturing organizations for drug substance process chemistry activities, focusing on late-stage and validation.
• Author and manage RFP documents, support regulatory submissions, and provide technical expertise for manufacturing scale-up and troubleshooting.
• Interface proactively with CMC team members and communicate process chemistry strategies effectively across departments.

BridgeBio pioneers a 'moneyball for biotech' approach, pooling projects and early-stage research from academia to reduce risk and develop life-changing medicines for rare diseases. The company fosters a culture of curiosity and experimentation, empowering teams to push boundaries and achieve the impossible.

• Lead the strategy, planning, execution, and maintenance of safety databases and outsourced PV activities.
• Oversee collection, evaluation, and reporting of safety data from clinical trials, shaping the safety governance framework.
• Manage PV vendor contracts, quality/compliance for ICSR case processing, and mentor PV operations associates.

MapLight Therapeutics is a clinical stage biotech company focused on drug discovery for central nervous system disorders. It is a growing organization that values open dialogue and mutual respect while developing novel therapies for psychiatric symptoms.

• Direct and manage a team of Project Directors and Project Managers in global project delivery.
• Provide leadership and oversight for clinical programs and act as primary escalation point for sponsors.
• Optimize profitability, manage resources, and ensure compliance with quality standards and regulations.

Precision Medicine Group provides clinical research and project management services for global clinical trials. The company promotes a culture centered on quality, people, clients, and performance.

• Set the pharmacy operational excellence strategy and lead cross-functional transformation initiatives.
• Partner with internal teams and vendors to align priorities and deliver measurable business impact.
• Ensure regulatory compliance and build scalable PBM operating models for end-to-end pharmacy experience.

Oscar is a health insurance company built around a full stack technology platform with a focus on serving members. Founded in 2012, it emphasizes authenticity and belonging in its culture.

• Lead global CMC regulatory strategy for the portfolio, including Phase 3 readiness and launch planning.
• Serve as the company's lead CMC voice with FDA, EMA, and other global health authorities.
• Build, lead, and develop a high-performing CMC Regulatory team as the company scales.

Kailera Therapeutics is a biopharmaceutical company developing novel therapies for obesity and related conditions. The company has an entrepreneurial, team-oriented culture and is passionate about creating an inclusive workplace.

• You will serve as the senior contracting leader for the Bloomington site, providing strategic oversight of customer contracts, quality agreements, supplier contracts, and contracting operations.
• You will partner closely with site leadership and business functions to support growth, ensure contractual and regulatory compliance, manage risk, and drive operational excellence.
• You will lead negotiation of complex customer agreements and supplier contracts, and develop a team of contracting professionals.

Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization (CDMO) that partners with pharmaceutical and biotech companies to bring sterile injectable products to market. The company emphasizes quality and continuous improvement, with a strong focus on cGMP manufacturing and support services.

• Own the Field Excellence operating model nationally, including cadence, standards, tools, and escalation protocols.
• Serve as the single operational partner to the VP Sales, managing territory, IC questions, and business review preparation.
• Manage and develop two Directors of Field Excellence and ensure launch readiness across all geographies.

Summit Therapeutics is a biopharmaceutical oncology company focused on improving quality of life and resolving serious unmet medical needs through clinical studies. The company is building its commercial infrastructure for a first US launch, with a mission-driven culture emphasizing integrity, collaboration, and commitment to people.

• Lead formulation and process development for inhaled dry powder products through scale-up and commercialization.
• Apply Quality by Design principles and statistical tools to ensure product quality and regulatory compliance.
• Collaborate with cross-functional teams and external CDMO partners to deliver CMC milestones and regulatory submissions.

Pulmovant is a biotechnology company developing inhaled dry powder therapies for serious pulmonary diseases. It is a lean, collaborative organization focused on bringing innovative treatments to patients with significant unmet medical needs.

• Lead program-level and portfolio-level planning and execution of CMC development for multiple small-molecule assets.
• Own detailed CMC project plans and risk registers, partnering with internal and external teams for on-time, within-budget delivery.
• Serve as primary point of contact for external CDMOs across China, EU, and US, overseeing manufacturing and documentation timelines.

Enveda is a clinical-stage, AI-enabled biotech company discovering medicines four times faster than the industry standard. The company recently raised $311M in Series E funding and has been recognized as one of America's Best Startup Employers and a Top 100 Most Loved Workplace.

• Own CMC end-to-end for a trispecific TCE program from discovery handoff to IND, including timeline, budget, and quality.
• Run competitive CDMO selection across US, European and Chinese vendors, then negotiate and manage the chosen partner.
• Author Module 3, build the pre-IND briefing package, and represent CMC in agency meetings.

Shennon Biotechnologies is developing precision immunotherapies for solid tumors using an integrated platform that profiles millions of single-cell interactions in a single experiment. The company values collaboration, ownership and authenticity and is based in San Francisco.

• Lead end-to-end global supply chain operations across clinical trial and commercial spaces, ensuring uninterrupted product availability and robust inventory levels.
• Collaborate with regulatory partners and distribution vendors to manage drug product shelf life, resupply, and shipping deadlines.
• Build and maintain relationships with manufacturing and packaging partners, while identifying risks and implementing mitigation strategies.

Compass Pathways is a biotechnology company dedicated to unlocking new treatment options in mental health care, with a focus on developing COMP360 psilocybin for treatment-resistant depression and PTSD. The company is headquartered in London, UK, with a US office in New Jersey, and leads the world's largest classic psychedelic clinical program.

• Lead and coach a team of more than 50 direct and indirect reports to ensure strong service performance and professional development.
• Oversee daily patient service center operations, ensuring compliance with SLAs, industry regulations, and privacy requirements.
• Monitor KPIs, analyze operational data, and implement improvements to enhance efficiency, service quality, and patient experience.

Our partner is a company in the regulated healthcare space, dedicated to delivering efficient and compliant patient support programs. They foster an inclusive, high-performing culture and manage a large team of over 50 direct and indirect reports.

• Own CMC strategy and execution across the full portfolio, spanning drug substance, drug product, device/combination products, and oral solid dose formulations.
• Lead process development, scale-up, technology transfer, and regulatory submissions for CMC and device sections to support global filings.
• Build and mentor a high-performing CMC and device engineering organization while partnering cross-functionally with Regulatory, Quality, Clinical, and Commercial teams.

Kailera Therapeutics is a late clinical-stage biotechnology company advancing a pipeline of GLP-1-based therapies for obesity and related conditions, including injectable and oral candidates in global trials. The company fosters an entrepreneurial, team-oriented culture focused on collaboration, integrity, and excellence as it scales toward commercial launch.

• Develop and execute the Quality practice's long-term growth strategy, expanding service offerings for biotech and pharma clients.
• Build and scale a high-performing Quality organization with strong P&L ownership and delivery excellence.
• Serve as a trusted advisor to executive leadership teams, providing strategic GxP quality leadership and oversight.

Syner-G accelerates breakthrough science and delivery of life-enhancing therapies through expertise, insight, consulting and management skills. The company was recently honored with BioSpace's "Best Places to Work" 2026 award for the third consecutive year, fostering a culture of growth, learning, and reward.

• Lead the development and implementation of an integrated Quality Management System (QMS) covering GxP activities across GMP and GCP functions.
• Oversee key quality processes including deviations, CAPA, change control, document control, training, risk management, and computerized system validation.
• Drive regulatory inspection readiness, including Pre-Approval Inspections, and establish quality metrics, dashboards, and continuous improvement initiatives.

This pharmaceutical and biotechnology company is preparing for commercialization of an innovative treatment. It is a growing organization focused on building scalable quality systems, fostering a culture of quality ownership, continuous improvement, and regulatory compliance.

• Serve as CMC regulatory expert, developing global submission strategies and assessing regulatory risks for development and commercial programs.
• Lead preparation and review of CMC submission content including CTD Module 2 and Module 3 sections, and support regulatory filings from IND to MAA.
• Guide CMC lifecycle management, regulatory authority interactions, and monitor emerging regulations to inform client strategies.

Opus Regulatory is a specialist consultancy providing experts in Regulatory Strategy, CMC, Labeling, and Ad Promo to biotech and pharmaceutical clients. Their team is made up of biopharmaceutical leaders and innovators focused on delivering the highest level of regulatory consulting service.