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.

1/21/2022
Environmental, Health, and Safety Specialist I

Our Operations Department seeks an Environmental, Health, and Safety Specialist I to play an critical role in maintaining industry standards throughout the development and manufacturing process. Under the supervision of the EH&S Manager, the EH&S Specialist I will plan, implement, and coordinate safety programs, requiring application of science/engineering principles and technology, to prevent or correct unsafe environmental working conditions. Successful candidates will demonstrate strong attention to detail and the ability to communicate effectively.  

Duties / Responsibilities  

  • Maintain and apply knowledge of current EHS policies, regulations, and industrial processes.
  • Apply broad knowledge of methods, precedents, and standards to significantly diverse and intense work complexities.
  • Recommend process and product safety features that will reduce employees' exposure to chemical, physical, and biological work hazards.
  • Assist in planning, coordinating, and executing engineering projects.
  • Execute the investing process that examine or assess the functionality, practicability, activity, and patterns of the engineering structures, elements, and instruments.
  • Manage the hazardous waste program.
  • Inspect facilities, machinery, and safety equipment to identify and correct potential hazards, and to ensure safety regulation compliance.
  • Develop EHS Management tools for tracking inspection findings, incidents, and near misses.
  • Investigate industrial accidents, injuries, or occupational diseases to determine causes and preventive measures.
  • Work to improve efficiencies through waste elimination and process improvements.
  • Confer with other personnel to resolve design or operational problems.
  • Interpret industrial hygiene sampling result and recommend controls to limit employee exposure.
  • Compile, analyze, and interpret statistical data related to occupational illnesses and accidents.
  • Communicating with Supervisors, Peers, or Subordinates — Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
  • Participate in pre-job planning and verification of controls/safeguards before new, high risk, and non-standard work begins.
  • Deliver EHS Training and facilitate workshops to onsite teams.

Required Knowledge/Skills/Abilities 

  • General knowledge of safety and hazardous waste regulations.
  • Knowledge of pharmaceutical manufacturing operations.
  • Strong understanding of HAZCOM, Respiratory Protection, Forklift Safety, and EHS inspections.
  • Excellent verbal and written communication skills.
  • Excellent interpersonal skills.
  • Excellent organizational skills and attention to detail.
  • Excellent time management skills with a proven ability to meet deadlines.
  • Strong analytical and problem-solving skills.
  • Ability to prioritize tasks and to delegate them when appropriate.
  • Ability to function well in a high-paced and at times stressful environment.

Education and Experience 

  • Bachelor’s degree in a scientific or engineering field
  • At least two years related experience required, preferably in a CDMO environment

Physical Requirements  

  • Prolonged periods of sitting at a desk and/or working on a computer
  • Wear safety and personal protective equipment for prolonged periods.
  • Requires brief periods of physical exertion such as climbing ladders, crouching, or lifting moderately heavy objects (15-25 lbs).

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 "Environmental, Health, and Safety Specialist I" in the email subject line.) 

1/13/2022
Principal Scientist / Engineer

Serán is searching for a Principal Scientist / Engineer to lead a team in Dosage Form Development. The role requires a combination of technical expertise and managerial / leadership skills to allow the team to collectively deliver high quality results on client projects. In addition to oversight of client-facing deliverables, the successful candidate will develop processes and training to improve transfer of process and formulation information into the GMP manufacturing environment.

The Principal Scientist / Engineer will also have the opportunity to expand and improve the technical capabilities, work streams, and capacity of the dosage form offering of the rapidly growing company. Importantly, the candidate will be expected to strategically balance improvements between development, clinical, and commercial manufacturing areas. A strong knowledge of the industry combined with a passion for collaboration will be required for this endeavor.

Supervisory Responsibilities

  • Manage daily activities of direct reports
  • Mentor direct reports

Duties / Responsibilities

  • Train and provide technical expertise to direct reports
  • Make project-level decisions that integrate technical considerations with business considerations
  • Drive prioritization across multiple projects
  • Expand and improve company capabilities for clinical and commercial manufacturing
  • Recruit team members and build team structures
  • Manage interfaces with different groups within the organization

Required Knowledge/Skills/Abilities

  • Expertise in formulation and process scale-up strategies for dosage form development
  • Expertise in unit operations for dosage form manufacturing
  • Fluent application of fundamental scientific and engineering concepts to guide decision-making where appropriate
  • Effective teaching and mentoring techniques
  • Proactive and effective communication skills

Education and Experience

  • Degree in pharmaceutical science, chemical engineering, mechanical engineering, chemistry, bioengineering, or closely related field
  • Minimum of 12 years of industrial experience in dosage form development with a Bachelor’s or Master’s degree. Minimum of 8 years of industrial experience with a PhD.

Physical Requirements

  • Prolonged periods of sitting at a desk and working on a computer.

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 "Principal Scientist / Engineer" in the email subject line.)  

 

1/13/2022
Maintenance and Calibration Supervisor

Our Operation Department seeks a Maintenance and Calibration Supervisor to play a crucial role in maintaining specialized equipment for the manufacturing of tablets, capsules and spray drying dispersion for the use of clinical FDA trials. Specifically, this role is responsible for coordinating, prioritizing, assigning, tracking, and overseeing all maintenance and calibration activities of production equipment and systems supporting manufacturing processing. Preference will be given to candidates with pharmaceutical industry experience to best inform decisions and provide direction for the assurance of product quality and manufacturing efficiency.  

Supervisory Responsibilities  

  • Recruits, interviews, hires, and trains new technicians 
  • Oversees daily workflow of Maintenance and Metrology Department 
  • Effectively communicates objectives and defines success metrics  
  • Assists in prioritizing technician’s daily tasks 
  • Provides constructive and timely performance evaluations  
  • Performs other supervisory related duties as assigned 

Duties / Responsibilities  

  • Responsible for managing the site calibration and maintenance programs for manufacturing equipment and facility support systems using the Computerized Maintenance Management System (CMMS) 
  • Applies expert knowledge to ensure company compliance to meet industry standards for all calibration aspects, including record keeping and labeling requirements.  
  • Coordinates contractor services for calibration, repairs, and service of equipment 
  • Manages and directs all process equipment maintenance activities including installation, modification, calibration, repairs, and preventative maintenance in accordance with cGMP compliant maintenance processes 
  • Direct maintenance personnel in best practices and ensures effective preventative and corrective maintenance to prioritize minimal disruption to operation schedule 
  • Ensures OOTs are effectively managed and closed promptly
  • Works closely with engineers to ensure the calibration specifications are appropriate for manufacturing processes support
  • Utilizes a Maximo Computerized Maintenance Management System (CMMS) to create E-datasheets, run reports, and ensure complete inductions were executed  
  • Communicates on behalf of the maintenance and calibration programs and responds effectively to inquiries prompted through internal and external compliance audits

Required Knowledge/Skills/Abilities 

  • Must have a broad knowledge of Pharmaceutical GMP and FDA & EMA regulations
  • Proven experience performing instrument calibrations 
  • Excellent verbal and written communication skills 
  • Excellent interpersonal and collaborative teamwork skills 
  • Excellent organizational skills and attention to detail 
  • Excellent time management skills with a proven ability to meet deadlines 
  • Strong analytical and problem-solving skills 
  • Ability to perform technical instrument troubleshooting 
  • Ability to prioritize tasks and to delegate them when appropriate 
  • Ability to function well in a high-paced and at times stressful environment 
  • Proficient with Microsoft Office Suite or related software 

Education and Experience 

  • Bachelor’s degree in engineering or facilities management, or equivalent experience as it pertains to the essential job functions 
  • A minimum of 5+ years as lead or supervisor experience within GMP/ISO regulated manufacturing environment 
  • Knowledge or experience in CDMO environment preferred 
  • Advanced knowledge of equipment maintenance and calibration systems   
  • Experience with Computerized Maintenance Management System (CMMS)   

Physical Requirements  

  • Prolonged periods of sitting at a desk and working on a computer.  
  • Must be able to lift 15 pounds at times.  

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 "Maintenance and Calibration Supervisor" in the email subject line.)  

1/13/2022
Operations Specialist I

Our Operation Department seeks an Operations Specialist I to play an integral role in maintaining specialized equipment for the manufacturing of tablets, capsules and spray drying dispersion for the use of early phase clinical FDA trials. 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. 

Duties / Responsibilities  

  • Operate specialized machinery to manufacture pharmaceutical products 
  • Works closely and communicates effectively with operations team  
  • Develops Good Manufacturing Practice (GMP)  
  • Follow strict standard operating procedures (SOP) 
  • Safely handle hazardous materials  
  • Weighs, measures, subdivides, and disposes of components 
  • Completes documentation, including logbooks and batch production and control records 
  • Cleans tools and equipment after use 
  • Maintains equipment 
  • Ability to remain in Tyvek suit for extended periods of time 

Required Knowledge/Skills/Abilities 

  • Mechanical aptitude 
  • Strong verbal and written communication skills  
  • Strong organization skills and attention to detail  
  • Proficient math and problem-solving skills  
  • Strong time management skills with ability to meet deadlines  
  • Ability to prioritize and ask for assistance to delegate tasks when appropriate  
  • Ability to focus in a fast-paced environment with shifting priorities  
  • Proficient with Microsoft Office Suite or related software  

Education and Experience 

  • Bachelor’s degree in chemistry, physics, engineering, or related scientific discipline will be prioritized, but not required 
  • Previous GMP experience not required, but preferred  

Physical Requirements  

  • Prolonged periods of sitting or standing while monitoring equipment 
  • Must be able to lift up to 25 pounds regularly, and up to 50 pounds occasionally  
  • Swing shift and weekend schedule with the possibility of 12-hour shifts  

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 "Operations Specialist I" in the email subject line.)  

1/13/2022
Operations Technician

Our Operation Department seeks an Operations Technician I to play an integral role in maintaining specialized equipment for the manufacturing of tablets, capsules and spray drying dispersion for the use of early phase clinical FDA trials. Adhering to strict standard operating procedures (SOP) and following good manufacturing practices (GMP) are required. Successful candidates will demonstrate strong attention to detail and focus within a fast-paced work environment with experience in teamwork, self-discipline, and proactive communication to ensure collective goals are achieved. Training available on-site. Those exhibiting successful candidate characteristics without pharmaceutical experience are encouraged to apply.    

Duties / Responsibilities  

  • Operate specialized machinery to manufacture pharmaceutical products 
  • Works closely and communicates effectively with operations team  
  • Comply with Good Manufacturing Practice (GMP)  
  • Follow strict standard operating procedures (SOP) 
  • Safely handle hazardous materials  
  • Weighs, measures, subdivides, and disposes of components 
  • Completes documentation, including logbooks and batch production and control records 
  • Cleans tools and equipment after use 
  • Maintains equipment 
  • Ability to wear a full Tyvek suit for extended periods of time 

Required Knowledge/Skills/Abilities 

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

Education and Experience 

  • High school diploma or equivalent  
  • Coursework or experience in chemistry or manufacturing field preferred  

Physical Requirements  

  • Prolonged periods of sitting or standing while monitoring equipment  
  • Must be able to lift up to 25 pounds regularly, and up to 50 pounds occasionally  
  • Swing shift and weekend schedule with the possibility of 12-hour shifts  

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 "Operations Technician" in the email subject line.)  

1/13/2022
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.)

1/13/2022
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.)

1/10/2022
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.

Duties/Responsibilities: 

  • Develop and execute analytical methods. 
  • Analyze and interpret data 
  • Participate in cross-functional teams 
  • Communicate key results both internally to the teams and externally to clients

Require Skills/Abilities 

  • Expertise in data analysis  
  • Good verbal, written and technical communication skills 
  • Excellent organizational skills and attention to detail
  • Strong analytical and problem-solving skills
  • Proficient with Microsoft Office Suite or related software 

Education / Experience 

  • Candidates must possess a degree in chemistry or related discipline
  • Candidates of all degree levels are encouraged to apply
  • Preference given to candidates with a background in analytical chemistry and materials characterization with experience working in a laboratory setting

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.)

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

 

 

1/5/2022
Laboratory Technician

Our Quality Control Department seeks a Laboratory Technician to play a critical role in supporting the ongoing sample testing performed by the Quality Control lab in support of good manufacturing practices (GMP) and customer satisfaction. This role requires strong attention to detail and focus within a fast-paced work environment. Successful candidates will demonstrate strengths in teamwork, self-discipline, and proactive communication to ensure collective goals are achieved. Those with limited lab experience are still encouraged to apply.   

Duties / Responsibilities   

  • Conducts appearance testing, solution preparation and pH measurements 
  • Supports raw materials sampling 
  • Logs-in samples and standards
  • Perform routine equipment, laboratory, and instrument maintenance  
  • Clean lab glassware and disposes of solvent 

Required Knowledge/Skills/Abilities 

  • Excellent verbal and written communication skills.  
  • Excellent interpersonal and internal customer service skills.  
  • Excellent organizational skills and attention to detail.  
  • Excellent time management skills with a proven ability to meet deadlines.  
  • Strong analytical and problem-solving skills.  
  • Ability to work as a team.   
  • Ability to prioritize tasks and to delegate them when appropriate.  
  • Ability to function well in a high-paced and at times stressful environment.  
  • Proficient with Microsoft Office Suite or related software.  

Education and Experience 

  • High school diploma with laboratory experience.  
  • Bachelor’s degree or coursework in chemical engineering, chemistry, materials science, or related field preferred.  
  • Those with limited lab experience are still encouraged to apply.   

Physical Requirements  

  • Prolonged periods of sitting at a desk and working on a computer  
  • Must be able to lift up to 15 pounds regularly, and up to 30 pounds occasionally  

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 "Laboratory Technician" 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.