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 global analytical development and QC strategy across the pipeline.
Oversee GMP operations, regulatory submissions, and FDA/CVM interactions.
Build and scale the AD organization, managing methods, stability, and outsourcing.
Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs. It is a well-funded startup with teams of scientists, veterinarians, engineers, operators, and creatives.
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.
Lead strategic engineering and construction activities for large capital projects valued at $50+ MM in continuous thermoplastics manufacturing.
Manage project scope, design, construction, budget, schedule, and quality from initiation to completion across US sites.
Provide technical stewardship, drive process optimization and automation, and mentor project teams and direct reports.
Sika is a worldwide specialty chemicals company developing systems and products for construction, transportation, and industrial manufacturing. With approximately 33,000 employees and operations in over 400 factories globally, Sika fosters an entrepreneurial culture focused on safety, sustainability, and employee empowerment.
Design and optimize manufacturing processes for pharmaceutical and biotech facilities, including PFDs, material and energy balances.
Develop P&IDs, utility systems, and equipment specifications while ensuring cGMP compliance and regulatory requirements.
Lead process engineering workstreams, collaborate with clients and multidisciplinary teams, and support automation and facility improvements.
They are a partner company providing process design and engineering solutions for pharmaceutical and biotechnology manufacturing facilities. They work with multidisciplinary teams and offer remote flexibility, focusing on cGMP-compliant and innovative engineering.
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.
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.
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.
Lead medical writing for one or more clinical programs and drive content strategy for clinical and regulatory documents.
Author and manage high-quality clinical study protocols, investigator's brochures, clinical study reports, and global regulatory submissions.
Collaborate cross-functionally, mentor direct reports, and incorporate process improvements to support R&D needs.
Deciphera is a biopharmaceutical company dedicated to developing innovative medicines for people living with cancer. They value diversity and offer a competitive compensation and benefits package, fostering a culture of collaboration and professional growth.
Serve as drug product technical leader for formulation, process development, scale-up, and technology transfer via external CDMOs.
Apply Quality by Design principles to define CQAs, CPPs, and robust control strategies for inhaled dry powder products.
Lead CMC submissions, regulatory interactions, and commercial readiness activities including PPQ and PAI support.
Pulmovant is a Roivant-backed clinical-stage biotechnology company focused on developing inhaled therapies for pulmonary diseases. It operates as a lean, collaborative team within the Roivant family, advancing a first-in-class candidate for PH-ILD through Phase 3 development.
Lead analytical development and control strategy for sterile injectable/parenteral products from development through commercialization.
Define analytical CMC strategies and regulatory submissions, including NDA Module 3 content and specifications.
Oversee stability programs, method lifecycle management, and external CDMO and contract laboratory execution.
Kailera is a biopharmaceutical company advancing novel therapies for obesity and related conditions. The company is an inclusive, team-oriented workplace with an entrepreneurial spirit focused on collaboration, integrity, and excellence.
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.
Oversee operational preparation and execution of regulatory submissions, ensuring technical compliance and timely delivery.
Manage routine submissions like INDs, CTAs, and health authority responses, while supporting complex filings and maintaining submission plans.
Compile, publish, and validate eCTD packages, coordinate submission delivery, and maintain accurate records in Veeva RIM.
A partner company of Jobgether, a pharmaceutical and biotechnology organization focused on developing innovative oncology therapies. The company values regulatory precision and operational efficiency across global programs, with a remote-first culture.
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.
Manage integrated CMC timelines and drive alignment across technical, clinical, and regulatory teams.
Coordinate CDMO/CMO deliverables, budgets, and regulatory submission milestones.
Facilitate cross-functional meetings, track risks and action items, and provide clear program visibility.
Pulmovant is a clinical-stage biotechnology company focused on developing treatments for pulmonary diseases, with a lead candidate for pulmonary hypertension associated with interstitial lung disease. As part of the Roivant family, it fosters a collaborative and innovative culture, leveraging resources to advance its pipeline.
Lead the planning, authoring, and delivery of regulatory documents for global development programs, health authority interactions, and marketing applications.
Develop strategic document plans and author complex submissions such as INDs, CTAs, IBs, CSRs, and briefing packages while ensuring ICH/GCP compliance.
Coordinate cross-functional teams, manage external vendors, mentor junior writers, and drive process improvements to maintain submission readiness.
The company is a biopharmaceutical organization focused on developing innovative therapies for patients with significant unmet medical needs. It operates as a remote, cross-functional team with a culture emphasizing regulatory excellence, collaboration, and career development.
Develop and maintain integrated project plans for global regulatory submissions, ensuring adherence to scope, timelines, budgets, and quality standards.
Act as the primary regulatory timeline contact across Clinical, Nonclinical, CMC, Quality, and Commercial functions, fostering collaboration and alignment.
Identify and mitigate project risks, prepare teams for agency meetings, and lead responses to regulatory queries from global health authorities.
Centessa Pharmaceuticals is a clinical-stage company developing orexin receptor 2 agonists for narcolepsy and other sleep-wake disorders. As a wholly owned subsidiary of Eli Lilly and Company, it shares a culture of caring and impact with over 50,000 employees.
Execute component-level data analysis and process insights using chemical and biochemical engineering principles.
Develop data management workflows to ensure integrity and traceability of manufacturing data for regulatory submissions.
Build knowledge management systems to capture organizational knowledge and champion a knowledge-sharing culture.
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect against bacterial diseases. The company is guided by core values such as rethinking convention and leading with heart, fostering an inclusive and collaborative culture.
Review and evaluate complex chemistry prompts and technical queries.
Explain chemical reactions, mechanisms, and structures clearly.
Provide expert-level feedback during AI-moderated sessions.
Terac is building the world's largest pool of vetted human experts for AI. Researchers, AI labs, and product teams use Terac to recruit, screen, and pay study participants across industries, languages, and skill sets.
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.