Jobs at Serán BioScience, LLC

Develops, optimizes, validates, and transfers analytical methods for small-molecule drug products and APIs in a GMP laboratory. Performs HPLC, dissolution, KF, and related testing; troubleshoots studies; generates data for CMC decisions; prepares regulatory-ready reports and protocols; identifies out-of-trend results; and collaborates with QC, QA, process development, project management, and clients. Provides analytical development subject-matter expertise, technical leadership, project updates, and process improvement recommendations.

Leads enterprise application deployment projects from planning through post-production support, including SAP S/4HANA implementations, cutover planning, testing, change governance, risk mitigation, vendor coordination, and stakeholder communications. Develops project plans, documentation, and readiness assessments while supporting data migration, system configuration reviews, training, and issue resolution. The role coordinates cross-functional teams and drives efficient, minimally disruptive technology implementations.

Oversee the proposal pipeline for new customers and projects, coordinating with business, technical, project management, and scheduling teams. Translate client needs into project scopes, timelines, costs, and pricing while ensuring proposal accuracy and quality. Support client discussions, RFI and RFP responses, sales efforts, proposal templates, costing templates, and continuous process improvement.

Lead daily operations of a commercial QC laboratory ensuring timely GMP-compliant analytical testing, product release, stability testing, investigations (OOS/OOT), audits/inspections readiness, staffing, training, and continuous improvement while partnering with Manufacturing, Supply Chain, Analytical Development, and QA.

The Senior Engineer will support the process development of pharmaceutical drug products, lead projects, communicate technical information, and collaborate across teams to meet milestones.

The Quality Assurance Associate supports quality systems in a GMP facility, managing programs, audits, and documentation. Responsibilities include training oversight, risk analyses, internal audits, and supporting quality improvement initiatives.

The Senior Process Engineer at Seran will lead the development and optimization of spray drying processes, ensuring compliance with GMP and collaborating with cross-functional teams.

The Account Manager will expand Seran's drug manufacturing portfolio by managing client relationships, guiding them through project execution, and ensuring alignment with company capabilities. Responsibilities include opportunity identification, agreement negotiation, and collaboration across teams.

The Project Manager at Seran Bioscience manages drug projects from initiation to completion, ensuring effective communication and coordination between clients and internal teams across various phases.

The Senior Scientist will develop and scale-up pharmaceutical processes, design experiments, and collaborate with other experts while mentoring teams and managing work plans.

The QA Engineer will review and approve validation of lifecycle activities, ensure compliance, support audits, and manage multiple projects.

The Director of Business Development drives customer growth, builds client relationships, manages proposals, and provides strategic market insights while collaborating with internal teams.

The Senior Scientist will lead analytical characterization and method development for pharmaceutical products, ensuring scientific rigor and managing projects while collaborating with cross-functional teams.

Manage capital projects from renovation to ground-up construction for pharmaceutical facilities. Lead multidisciplinary teams, manage contractors, budgets, schedules, project controls, safety, contracts, and stakeholder communications while ensuring cGMP and regulatory compliance.

Support QC environmental monitoring and microbiology testing for pharmaceutical manufacturing: perform viable/non-viable and utility testing, cleaning verification, trend data analysis, write protocols/reports/investigations/CAPAs, maintain lab practices and cGMP compliance, coordinate sampling, and participate in continuous improvement and cross-functional initiatives.

The Director of Quality Engineering oversees validation and assurance programs, ensuring compliance with FDA and international regulations while leading cross-functional teams and managing Quality Engineering initiatives.

The EHS Specialist will manage environmental health and safety programs, ensure regulatory compliance, lead audits, conduct training, and support the overall safety culture in the organization.

Lead QA operations overseeing clinical manufacturing, warehouse, raw material and drug product disposition. Manage QA team, approvals (investigations, CAPAs, SOPs, batch records), ensure cGMP compliance, support audits/inspections, and drive continuous improvement and cross-functional quality oversight.