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Director, Quality Engineering & Computer System Assurance
Summary:
Serán BioScience seeks a Director, Quality Engineering & Computer System Assurance (CSA) to oversee and provide strategic and operational leadership for the organization’s validation, qualification, and computerized systems assurance programs. This role will support GMP manufacturing, laboratory, aEmployment Type: Full-time Exempt
Sample Management Associate
Summary:
Sample coordination and receipt from other departments for internal and external testing Manages QC sample inventory, including in-process, release, retain, and stability samples Ships samples to external Contract Testing Laboratories (CTL) Follows up with CTLs on testing and turnaround times to ensEmployment Type: Full-time Exempt
Facilities Custodian
Summary:
P erform s daily maintenance tasks to ensure the facilities are exceptionally clean and organized. Empt i es refuse containers. Disinfects, cleans, and maintains common employee areas, including restrooms and kitchens. Selects and uses appropriate PPE provided by C ompany . Removes, installs, cleansEmployment Type: Full-time Exempt
Senior Scientist
Summary:
Serán seeks a Senior Scientist to join the Analytical Sciences group to play a key role in analytical characterization and method development for novel pharmaceutical drug products. This role supports process and process development by serving as a technical leader within the laboratory, driving metEmployment Type: Full-time Exempt
Quality Control Scientist I
Summary:
Adheres to Standard Operating Procedures, cGMPs, Quality Manual, and company policies Performs routine testing using analytical equipment including but not limited to HPLC, GC, KFC, Disso, etc. Conducts appearance testing, raw materials sampling, solution preparation, and pH measurements Drafts stabEmployment Type: Full-time Exempt
Vice President of Quality
Summary:
Serán BioScience is searching for an experienced leader within pharmaceutical manufacturing to lead and support the Quality organization to continue to improve quality systems and compliance. The Vice President of Quality plays a pivotal role in ensuring the highest standards of quality and complianEmployment Type: Full-time Exempt
Quality Assurance Engineer
Summary:
Serán BioScience is expanding and looking for a Quality Assurance Engineer with industry experience to join at this exciting time. The QA Engineer will be part of a cross functional team that will be responsible for the review and/or approval of qualification/validation of all the lifecycle activitiEmployment Type: Full-time Exempt
Senior Process Engineer, Spray Drying
Summary:
System owner of commercial spray drying equipment, including solution preparation, spray drying, and secondary drying systems Assess and implement continuous improvements of spray dryer and associated unit operations Collaborate with other departments on strategy and schedules for spare parts, preveEmployment Type: Full-time Exempt
Quality Assurance Associate II/III (Swing Shift)
Summary:
Serán BioScience is searching for an experienced Quality Assurance Associate to aid in regulatory compliance for the manufacturing of oral solid dosage drug products. The primary responsibilities of this role will be to support the daily activities of Serán’s Quality Assurance department by ensurinEmployment Type: Full-time Exempt
Project Manager
Summary:
Manages 5-8 compounds simultaneously throughout the entirety of their program lifespan Serves as primary interface between the client and the Seran internal project team Facilitates information flow between internal teams and client for materials, shipments, documents, project updates, meeting agendEmployment Type: Full-time Exempt
Associate Project Manager
Summary:
The Associate Project Manager role with Seran Bioscience plays a crucial supporting role in the CMO lifespan of a drug. With this role, you work closely with clients to manage a project from initiation, through formulation and development, manufacturing, and beyond completion. You will need excellenEmployment Type: Full-time Exempt
Quality Assurance Engineer
Summary:
Serán BioScience is expanding and looking for a Quality Assurance Engineer with industry experience to join at this exciting time. The QA Engineer will be part of a cross functional team that will be responsible for the review and/or approval of qualification/validation of all the lifecycle activitiEmployment Type: Full-time Exempt
Director, Quality Engineering & Computer System Assurance
Summary:
Strategic Leadership Develops and implements the site strategy for Quality Engineering and Computer System Assurance(CSA) programs Supports the establishment governance structures for risk-based validation lifecycle management including planning, execution, maintenance, and periodic review Leads iniEmployment Type: Full-time Exempt
Account Manager, Commercial Manufacturing
Summary:
Identify, qualify, and pursue new commercial manufacturing opportunities for oral solid drug products Build and maintain a robust pipeline of prospects aligned with Serán’s technical capabilities and capacity strategy Conduct initial technical and commercial assessments to ensure strong project fitEmployment Type: Full-time Exempt
Quality Control Scientist I/II, Environmental Monitoring/Microbiology
Summary:
The Quality Control Scientist, EM & Microbiology will be responsible for maintaining the EM/Micro program at Serán BioScience. This role supports manufacturing through performing routine monitoring testing, utility testing, and cleaning process verifications testing. Work performed must be in accordEmployment Type: Full-time Exempt
Quality Assurance Engineer
Summary:
Serán BioScience is expanding and looking for a Quality Assurance Engineer with industry experience to join at this exciting time. The QA Engineer will be part of a cross functional team that will be responsible for the review and/or approval of qualification/validation of all the lifecycle activitiEmployment Type: Full-time Exempt
Scientist II
Summary:
Serán seeks a Scientist II to join the Analytical Sciences group to play a key role in the analytical characterization and method development of novel pharmaceutical drug products as an integral part of collaborative project teams. This role performs hands‑on testing, develops analytical protocols fEmployment Type: Full-time Exempt
Business Development Associate, Inside Sales
Summary:
Serán is expanding the Business Development team and is searching for a BD Associate dedicated to inside sales. This role will be responsible for the growth of Serán’s business through managing the lead generation and progression process. As part of the Business Operations team, the role will act aEmployment Type: Full-time Exempt
Principal Scientist (Process Definition and Scale-Up)
Summary:
The Principal Scientist, Development Project Lead will lead projects that scale up and define the processing space of oral solid pharmaceutical products as they advance into and through stage 1 of process validation. Success in this role also includes a smooth transfer of technical knowledge to theEmployment Type: Full-time Exempt
Quality Control Scientist I/II, Environmental Monitoring/Microbiology
Summary:
The Quality Control Scientist, EM & Microbiology will be responsible for maintaining the EM/Micro program at Serán BioScience. This role supports manufacturing through performing routine monitoring testing, utility testing, and cleaning process verifications testing. Work performed must be in accordEmployment Type: Full-time Exempt
Associate Director of Quality Assurance, Analytical and Client Services
Summary:
The Associate Director of Clinical Quality Assurance plays an integral role in fostering a culture of quality, efficiency, and excellence; ensuring that quality and compliance are integrated into the day-to-day operations and long-term Quality strategy. This position will provide strategic directionEmployment Type: Full-time Exempt
Cleaning Validation Engineer III, Manufacturing Science and Technology
Summary:
The Cleaning Validation Engineer III oversees the equipment Cleaning Program, supporting equipment cleaning and verification of cleanliness while ensuring compliance with GMP standards. Near-term work is focused on clinical manufacturing, but the engineer positions the program for future success inEmployment Type: Full-time Exempt