Serán BioScience

CDMO offering drug formulation & manufacturing

Quality Control Scientist 1/2 - In-Process Control

Regulatory & Quality (Life Sciences)Updated on Nov 13

Full-timeBend, OR, USA

About the Job

Requirements

Proven analytical instrumentation experience, preferably high-performance liquid chromatography, with at least 1–2 years in a current good manufacturing practice pharmaceutical industry laboratory.
Ability to communicate effectively and maintain productive relationships with coworkers, clients, and external contacts.
Ability to follow detailed written and oral instructions.
Ability to collaborate and work in cross-functional teams.
Strong organizational skills and attention to detail.
Ability to multitask and adjust priorities in a fast-paced environment while maintaining focus and managing disruptions or unexpected needs.
Strong analytical and problem-solving skills.
Ability to accept feedback from a variety of sources and constructively manage conflict.
Ability to prioritize tasks and keep leadership apprised of performance against timelines.
Proficiency with Microsoft Office Suite or related software.
Bachelor’s degree in a scientific discipline or related field.
At least 3 years of dedicated laboratory experience and 2 years of good manufacturing practice experience.
Ability to attend work consistently and predictably in person.
Ability to sit or stand for prolonged periods at a desk and work on a computer, and to stand or sit for prolonged periods while monitoring laboratory equipment.
Ability to lift up to 15 pounds at times.

Responsibilities

Adhere to Standard Operating Procedures, current good manufacturing practices, the Quality Manual, and company policies.
Perform routine extractions for dissolution, assay, and impurities testing.
Perform routine testing using analytical equipment, including KFC, dissolution apparatus, water activity equipment, and Fourier-transform infrared spectroscopy.
Conduct appearance testing, raw materials sampling, solution preparation, and pH measurements.
Draft stability tables, set up stability studies, and log in samples and standards.
Clean the laboratory and glassware and dispose of analytical waste appropriately.
Participate in process improvement and other non-routine projects.
Conduct peer review of routine testing at management’s discretion.
Perform hypothesis testing or investigative work for out-of-specification results under management and subject matter expert guidance.
Train and mentor staff on established processes and procedures.
Provide cross-functional support to other Quality Control teams.
Perform other related duties as assigned.

Desired Qualifications

Experience with Empower.

Serán BioScience is searching for an experienced Quality Control Scientist II to support an extended manufacturing schedule. This role would support all testing functions for Quality Control, primarily focused on in-process control lab methods to ensure manufacturing excellence. The Scientist II needs to exhibit experience and confidence within a cGMP laboratory with proficiency in analytical equipment operations and data record management.

The swing shift is a consistent weekly schedule of four 10-hour shifts, Monday - Thursday from 2:00 pm - 1:00 am. A shift differential of 10% of base salary will be applied. Salary is commensurate with experience.

Duties and Responsibilities

Adheres to Standard Operating Procedures, cGMPs, Quality Manual, and company policies
Performs routine extractions for dissolution, assay, and impurities testing
Performs routine testing using analytical equipment including but not limited to KFC, dissolution apparatus, water activity, FTIR, etc.
Conducts appearance testing, raw materials sampling, solution preparation, and pH measurements
Drafts stability tables, sets-up stability studies, logs-in samples and standards
Cleans lab and glassware and disposes of analytical waste appropriately
Participates in process improvement and other non-routine projects
Conducts peer review of routine testing at the discretion of management
Performs hypothesis testing or investigative work for OOS results under management and SME guidance
Trains and mentors staff on established processes and procedures
Demonstrates cross-functional support capabilities with other QC teams
Responsibilities may increase in scope to align with company initiatives
Performs other related duties as assigned

Required Skills and Abilities

Proven analytical instrumentation experience (preferably HPLC) with at least 1-2 years in a cGMP pharmaceutical industry laboratory
Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the Company
Follow detailed written and oral instructions
Demonstrated ability to collaborate and work in cross-functional teams
Strong organizational skills and attention to detail
Multitasks and adjusts priorities in a fast-paced environment, while maintaining focus and managing disruption and/or unexpected needs
Strong analytical and problem-solving skills
Accepts feedback from a variety of sources and constructively manages conflict
Ability to prioritize tasks and to keep leadership apprised of performance to timelines
Experience with Empower preferred
Proficient with Microsoft Office Suite or related software

Education and Experience

Bachelor’s degree in a scientific discipline or related field
Minimum of 3 years of dedicated lab experience
Requires 2 years of GMP experience

Physical Responsibility

Prolonged periods of sitting or standing at a desk and working on a computer.
Prolonged periods of standing or sitting while monitoring laboratory equipment.
Must be able to lift up to 15 pounds at times.
Adheres to consistent and predictable in-person attendance.

Benefits

Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.

Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Benefits Summary:

Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.

The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701

About the Company

Serán BioScience

CDMO offering drug formulation & manufacturing

Serán Bioscience is a contract development and manufacturing organization that helps pharmaceutical companies develop and manufacture drugs. It offers preformulation, formulation and dosage-form development, spray drying and particle engineering, plus cGMP manufacturing and analytical quality control. It relies on flexible, client-tailored services and a broad technical toolkit to support a range of clients from startups to large pharma. Its goal is to enable efficient, compliant drug development and production with rigorous quality standards.

Company size: 51-200
Company stage: Growth Equity (Venture Capital)
Total funding: $200M
Headquarters: Bend, OR
Founded: 2016

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