Jobs at Serán BioScience, LLC

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.

Leads analytical method development, optimization, validation, transfer, and lifecycle management for small-molecule drug products in a GMP environment. Performs testing using HPLC, GC, dissolution, water content, and water activity methods; supports QC laboratories, OOS/OOT investigations, discrepancy reports, and CMC decision-making. Prepares regulatory-ready documentation, collaborates cross-functionally, mentors teams, provides technical leadership, and drives analytical strategy and process improvements.

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.

Oversee pharmaceutical quality assurance activities in a GMP facility, including supplier quality, internal and vendor audits, regulatory and client audit support, quality risk management, quality agreements, CAPA, investigations, change management, and continuous improvement. Author, review, and approve quality documents while administering quality systems and ensuring compliance with FDA and EMA expectations.

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.

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 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.

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.

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.