Careers at Serán

Serán is currently seeking motivated pharmaceutical professionals. If you would like to join us, we invite you to submit your resumé and a brief cover letter for consideration to careers@seranbio.com.

Serán Bioscience, LLC provides custom formulation, process development and clinical manufacturing services for the pharmaceutical and biotech industries. Challenging projects and our drive to deliver on clients’ timelines make for a fast-paced, collaborative and rewarding work environment. Serán is located on the eastern slopes of the Cascade mountains in Bend, Oregon, affording our employees unique options for recreation and relaxation outside of work.

11/22/2021
Engineer I

Our Development Department seeks an Engineer I to play an integral role in identifying and implementing creative solutions to meet our client’s goals. Collaborating within an interdisciplinary team, this position will work to develop and scale-up pharmaceutical manufacturing processes. This role requires strong hands-on laboratory skills and the ability to apply fundamental scientific principles to solve problems. Successful candidates will demonstrate strengths in data collection, analysis, and proactive communication to ensure collective goals are achieved.

Duties/Responsibilities

  • Work independently on experiments using basic laboratory skills while following written protocols
  • Work in a team to execute pharmaceutical unit operations with direction
  • Develop experimental plans with direction from team leaders
  • Collect, analyze, and summarize data with direction from team leaders
  • Develop skills in data analysis and reporting internally and to clients
  • Develop operating procedures and guidelines for process equipment
  • Perform routine equipment, laboratory, and instrument maintenance

Required Knowledge/Skills/Abilities

  • Strong verbal and written communication skills
  • Strong organization skills and attention to detail
  • Strong analytical and problem-solving skills
  • Strong time management skills with ability to meet deadlines
  • Ability to prioritize and delegate tasks when appropriate
  • Ability to enjoy a fast-paced environment with shifting priorities
  • Proficient with Microsoft Office Suite or related software

Education and Experience

  • Bachelor’s or Master’s degree in chemical engineering, chemistry, bioengineering, mechanical engineering, materials science, physics, or closely related field.
  • Demonstrated research experience is desirable.

Physical Requirements

  • Prolonged periods of sitting at a desk and working on a computer
  • Must be able to lift up to 25 pounds regularly, and up to 50 pounds occasionally

 

 

10/13/2021
IT Manager

Job Summary:

  • Implements IT projects and solutions and supports business computer systems, networks, and users.
  • Emphasis on help desk management and deploying, managing, and supporting laboratory informatics in a GMP environment.

Supervisory Responsibilities:

  • Manages help desk ticketing and IT support workflow.
  • Coordinates and supervises technical support efforts with external IT vendors.
  • Manages IT inventory and supplies.

Duties/Responsibilities:

  • Deploys, manages, and supports IT solutions in business and analytical laboratory environments.
  • Helps define IT infrastructure strategy, architecture, and processes.
  • Collaborates with IT support contractors.
  • Hardware and software installation and configuration for client workstations, servers, and network infrastructure.
  • Supports end users and systems.
  • User administration.
  • Accurately follows IT and regulatory standard operating procedures as required.
  • Performs other IT-related duties as assigned.

Required Knowledge/Skills/Abilities:

  • Windows Server and Active Directory configuration and administration.
  • Skill in administration of Microsoft Exchange, SharePoint, and related Microsoft 365 services.
    Firm grasp of IT infrastructure and operations best practices.
  • Excellent working knowledge of servers, desktop computer systems, network and systems administration, data storage systems, logical security, and mobile devices.
  • Ability to understand and adhere to IT and pharmaceutical (GMP) industry regulations on electronic records, networks, and systems.
  • Excellent interpersonal and customer service skills.
  • Strong analytical and problem-solving skills.
  • Strong supervisory and leadership skills.
  • Strong project management skills.
  • Ability to prioritize tasks and delegate when appropriate.
  • Ability to learn and adapt to new IT-related technologies.
  • Recommended knowledge of laboratory informatics systems such as Agilent CDS, Waters, Thermo-Fisher, etc.

Education and Experience

  • Bachelor’s degree in Information Technology, Computer Science, Information Systems, or related field, or equivalent IT-industry certification and/or experience.
  • Minimum two years related experience required.
  • Experience leading and managing IT projects and deploying IT infrastructures across various technologies.
  • Recommended experience in laboratory informatics implementation and support.

 

If you are interested in joining the Serán team, we invite you to submit your resumé and a brief cover letter for consideration to careers@seranbio.com. (Please include "IT Manager" in the email subject line.)

10/5/2021
Project Manager

The Project Manager (PM) with Seran Bioscience plays a crucial role in the CMO lifespan of a drug. In this role, you work closely with clients to manage a project from initiation, through formulation and development, manufacturing, and beyond completion. You will need excellent collaboration, communication, management, organization, and planning abilities. You will be responsible for managing project timelines, influencing, and supporting the internal teams, and for reporting regular updates directly to clients. Each project lifespan can be broken into 6 unique phases for which the PM is responsible: Initiation, Planning, Execution, Coordination, Monitoring, and Closing.

The PM responsibilities at each of these phases is as follows:

  • 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 agendas, and timelines.
  • Owns the overall project timeline, schedule, and resources. Ensures internal teams are well informed on project timelines and goals, helps facilitate information transfer within internal teams.
  • Maintains consistent and accurate communication with the client via regularly scheduled and ad-hoc updates.
  • Prepares internal teams and client for upcoming project needs or internal team project transfers
  • Communicates project execution to the client and schedules regular meetings, both internal and external, to review the execution of each project phase with the technical team.
  • Onboards projects into our QADC system, works closely on a regular basis with QA to ensure cGMP quality compliance throughout project lifespan.
  • Oversees and influences across departments to coordinate program support as needed.
  • Manages timeline, budget forecasting, resource planning, project meetings, document tracking, and owns the overall project progress. Communicates risk internally and externally. Ensures project milestones are communicated and met.
  • Acts as primary point of contact for external resources and client queries.
  • Schedules and coordinates project meetings both internally and externally.
  • Oversees, coordinates, and tracks shipments of all project/client materials.
  • Other duties as assigned.

This role requires at minimum a Bachelor’s degree, with an emphasis in chemistry, biology, engineering, materials science, physics or a closely related field preferred. 3-5 years of relevant experience is desired. The Project Manager is responsible for relaying critical project status and technical updates to Serán’s clients and needs to have highly developed communication and writing skills.

If you are interested in joining the Serán team, we invite you to submit your resumé and a brief cover letter for consideration to careers@seranbio.com. (Please include "Project Manager" in the email subject line.)

9/13/2021
Operations Technician

We currently are seeking entry-level Operations Technicians to join Serán’s expanding GMP clinical manufacturing team. The manufacturing team plays a critical role in bringing novel therapeutics to patients with unmet clinical needs.  Responsibilities include, but are not limited to, equipment setup, staging of materials, and the disassembly and cleaning of equipment in accordance with standard operating procedures. The Operations Technician will assist in daily, weekly, monthly, and quarterly cleaning of processing rooms and the manufacturing facility.  There is potential for Technicians who highly perform and thrive in the GMP environment to be further trained and expand their responsibilities to include participation in the execution of complex manufacturing processes.  The Operations Technician must be able to work in a clean room environment while wearing personal protective equipment and occasionally assist with the movement of heavy materials and equipment.

The role of the Operations Technician at Serán demands an appreciation for and commitment to safety, precision, and quality.  The successful candidate is someone who thinks like an owner and approaches his/her work with exceptional attention to detail and accountability.  Individuals who thrive in a team setting and possess a passion for patient health are encouraged to apply.

 

If you would like to join the Serán team, we invite you to submit your resumé and a brief cover letter for consideration to careers@seranbio.com. (Please include "Operations Technician" in the email subject line.)

9/13/2021
Operations Specialist I

We currently are seeking an entry-level Operations Specialist I to join Serán’s expanding GMP clinical manufacturing team.  The manufacturing team plays a critical role in bringing novel therapeutics to patients with unmet clinical needs.  Operations Specialists are responsible for cleaning, assembling, and system testing equipment; dispensing activities, execution of complex manufacturing processes in a clean room environment, and ultimately becoming a Subject Matter Expert on intricate equipment and processes. The role of an Operations Specialist I at Serán demands an appreciation for and commitment to safety, precision, teamwork, and quality.

The successful candidate must have a mechanical aptitude and be able to work while wearing appropriate personal protective equipment and occasionally assist with the movement of heavy materials and equipment. Prior GMP experience is not required.  Recent college graduates with Bachelor of Science degrees are encouraged to apply.  The successful candidate is someone who thrives in a collaborative team setting, approaches their work with exceptional attention to detail and accountability, and has a passion for patient health.

 

If you would like to join the Serán team, we invite you to submit your resumé and a brief cover letter for consideration to careers@seranbio.com. (Please include "Operations Specialist I" in the email subject line.)

9/27/2021
Analytical Scientist

Serán seeks to hire an Analytical Scientist to join an interdisciplinary team working to develop and manufacture pharmaceutical drug products. The analytical scientist will be expected to develop and execute analytical methods, analyze and interpret data, participate in cross-functional teams, and to communicate key results both internally and externally to Serán’s clients. The ideal candidate will demonstrate excellent laboratory technique, problem-solving and organizational skills, and attention to detail. Expertise in data analysis and technical communication are also highly valued skillsets for this role. Both entry level and experienced candidates are encouraged to apply.

Candidates must possess a degree in chemistry or related discipline. Candidates of all degree levels are encouraged to apply. A background in analytical chemistry and materials characterization and experience working in a laboratory setting is preferred.

If you would like to join the Serán team, we invite you to submit your resumé and a brief cover letter for consideration to careers@seranbio.com. (Please type "Analytical Scientist" in email subject line.)

9/13/2021
Validation Engineer

Serán is seeking a Validation Engineer who is responsible for managing, scheduling, and executing qualification and validation activities. The successful candidate will support all facets of the validation life cycle including design, operation, continuous improvement and decommissioning.

 

Job Responsibilities

Develop and manage system lifecycle documentation consisting of User Requirements (URS), Functional and Design Specifications, Testing Protocols (Cx/IQ/OQ/PQ), Traceability Matrix, Qualification Summary Reports, Change Control, and Risk Assessments.

Assist with the generation and maintenance of SOPs and supporting documents.

Work with cross-functional teams to troubleshoot equipment, process, and validation issues.

Perform job responsibilities in compliance with applicable GMP regulations and guidelines as applied to the fields of Systems Qualification, Cleaning, and Process Validation.

Ensure equipment is released for GMP use within agreed-upon timelines following qualification and cleaning activities.

Perform investigations, CAPAs, change requests, and engineering projects.

 

Position Requirements

Minimum of a bachelor’s degree, preferably in a scientific discipline. Equivalent experience may be considered in lieu of degree.

3+ years previous GMP experience with background in the Pharmaceutical, Biotech, Chemical, Validation, or QA industry.

Must have a broad knowledge of Pharmaceutical GMP and FDA and international regulations.

General understanding of change control, CAPA programs, investigation and root cause analysis, and good documentation practices.

Must be organized and manage work responsibilities while working independently with minimal oversight. Time and project management skills with the ability to multi-task are essential.

 

If you would like to join the Serán team, we invite you to submit your resumé and a brief cover letter for consideration to careers@seranbio.com. (Please include "Validation Engineer" in the email subject line.)

9/13/2021
Quality Assurance Associate

As a Quality Assurance (QA) Associate, you will be responsible for supporting the day-to-day activities of the QA department at Serán.  Our Good Manufacturing Practice (GMP) facility currently manufactures clinical-stage pharmaceutical products, with plans to manufacture commercial batches in 2023. Tasks include production record review, analytical data review, internal QA document review, and support of the production floor.  Additional responsibilities include assisting in the maintenance of the electronic Quality Management System (QMS), conducting risk analyses and investigations, and participating in audits/inspections.

Job responsibilities include, but are not limited to:

  • Implementation and continuous improvement of the company’s quality systems
  • Document authorship, review, and approval of SOPs, batch production and quality control (QC) records, certificates of analysis, method validations, and equipment qualifications
  • Oversight of investigations
  • Corrective and preventative actions (CAPA) program management
  • Support of internal audits, client audits and regulatory inspections, as needed

Position requirements:

  • Minimum of a bachelor’s degree, preferably in a scientific discipline
  • 2+ years previous GMP, QC or QA experience
  • Knowledge of GMP and FDA regulations for clinical trial materials; commercial knowledge is desirable but not required
  • General understanding of change control procedures, CAPA program, investigation and root cause analysis, and good documentation practices
  • Strong written communication skills, attention to detail, and an ability to perform in a dynamic work environment
  • Competency in Microsoft Office applications

If you would like to join the Serán team, we invite you to submit your resumé and a brief cover letter for consideration to careers@seranbio.com. (Please include "Quality Assurance Associate" in the email subject line.)

Serán is a growing, science-focused company committed to its clients and dedicated to solving complex problems.  Our collaborative environment provides curious and motivated professionals the opportunity to explore new challenges and deepen their skills while being mentored by a team of industry experts.

If you would like to join us, we invite you to submit your resumé and a brief cover letter to careers@seranbio.com. Please include the name of the position in the email subject line.

 


Serán BioScience, LLC is an Equal Employment Opportunity employer. We celebrate diversity and do not discriminate based on race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability status, or any other applicable characteristics protected by law.