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Scientist II/III (Cleaning Validation)

Serán BioScience is searching for an experienced Scientist to help develop and maintain Cleaning Validation within the Analytical Development Department. This position will be responsible for drafting, executing, and finalizing validation protocols, and providing technical support for cleaning validations and swab recovery studies. Ideal candidates will have a strong chemistry background with several years of relevant experience. While all levels of experience are encouraged to apply, preference will be given to candidates with experience developing and implementing cleaning validation programs within a pharmaceutical manufacturing environment.


Duties and Responsibilities
  • Demonstrates knowledge performing analyses used to assess the swab recovery of active pharmaceutical ingredients
  • Fluently applies fundamental scientific principles to solve problems and guide decisions
  • Identifies opportunities for improvement and propose solutions
  • Follows written protocols to execute basic and advanced procedures such as analytical protocols, laboratory experiments, or manufacturing processes
  • Develops experimental protocols and templates with minimal guidance
  • Summarizes, reports, and analyzes data to draw conclusions, with guidance
  • Communicates technical information to internal teams
  • Communicates technical information to external partners, with guidance
  • Contributes to technical reports and presentations, with guidance
  • Adheres to consistent and predictable in-person attendance
  • Responsibilities may increase in scope to align with company initiatives
  • Other related duties as assigned


Required Skills and Abilities
  • Strong verbal and written communication skills
  • Demonstrated ability to collaborate and work in cross-functional teams.
  • Strong organizational skills and attention to detail
  • Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the Company.
  • Strong time management skills with a proven ability to meet deadlines
  • 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, including HPLC experience
  • Ability to prioritize tasks and to keep leadership apprised of performance to timelines
  • Accepts feedback from a variety of sources and constructively manages conflict
  • Proficient with Microsoft Office Suite or related software.


Education and Experience
  • BS in Chemistry or other related scientific discipline
  • Minimum of 2 years of relevant experience within the pharmaceutical development industry
  • GMP experience preferred, but not required


Physical Requirements
  • Prolonged periods of sitting or standing at a desk and working on a computer
  • Prolonged periods of sitting or standing in laboratory environment
  • Must be able to lift up to 15 pounds regularly and 25 pounds occasionally
  • Motor skills for basic laboratory operations


Compensation correlates to skills and experience presented by selected candidate. Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.


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.

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Average salary estimate

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$90000K

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What You Should Know About Scientist II/III (Cleaning Validation), Serán Bioscience

Are you passionate about shaping the future of pharmaceutical manufacturing? Serán BioScience in Bend, Oregon, is on the lookout for a talented Scientist II/III specializing in Cleaning Validation to join our dynamic Analytical Development Department. You'll be at the forefront of developing and maintaining cleaning validation protocols, ensuring that our processes meet the highest standards. In this role, you'll take charge of drafting, executing, and finalizing validation protocols, while also providing essential technical support for cleaning validations and swab recovery studies. If you thrive in a collaborative environment and have a strong chemistry background with hands-on experience in pharmaceutical settings, we want to hear from you! We're especially keen on those who have developed and implemented cleaning validation programs. Your daily tasks will include performing analyses, developing experimental protocols, and communicating technical findings to both internal teams and external partners. Whether you're devising solutions for complex problems or summarizing data to draw actionable insights, your contributions will directly impact our operations. With a strong focus on teamwork and effective communication, you'll help foster a productive environment. We value attention to detail, organizational skills, and the ability to manage multiple tasks in our fast-paced workplace. Come and make your mark at Serán BioScience - a place where innovation meets opportunity!

Frequently Asked Questions (FAQs) for Scientist II/III (Cleaning Validation) Role at Serán Bioscience
What are the responsibilities of a Scientist II/III at Serán BioScience?

As a Scientist II/III at Serán BioScience, you will be responsible for drafting, executing, and finalizing cleaning validation protocols, providing technical support for cleaning validations and swab recovery studies, and developing experimental protocols. Your expertise will be crucial in ensuring compliance and quality in our pharmaceutical manufacturing processes.

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What qualifications do I need to apply for the Scientist II/III position at Serán BioScience?

To apply for the Scientist II/III position at Serán BioScience, you should have a Bachelor's degree in Chemistry or a related scientific discipline, along with a minimum of 2 years of relevant experience in the pharmaceutical development industry. Experience in GMP is preferred but not mandatory.

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How does Serán BioScience support the growth and development of its Scientists?

Serán BioScience is committed to the professional growth of its employees, offering comprehensive training programs, mentorship opportunities, and a collaborative environment where innovative ideas are encouraged. This ensures that our Scientists, including those in the Scientist II/III role, can continuously develop their skills and expertise.

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What skills are essential for success as a Scientist II/III at Serán BioScience?

Successful candidates for the Scientist II/III position at Serán BioScience should possess strong analytical and problem-solving skills, excellent verbal and written communication abilities, and the capacity to collaborate in cross-functional teams. Attention to detail and strong organizational skills are also crucial in this fast-paced environment.

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What benefits can I expect when working as a Scientist II/III at Serán BioScience?

Serán BioScience offers a competitive benefits package that includes over four weeks of paid time off annually, employer retirement contributions, various health plans, life and long-term disability coverage, as well as an Employee Assistance Program. These benefits support both your personal and professional wellbeing.

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Common Interview Questions for Scientist II/III (Cleaning Validation)
What experience do you have with cleaning validation?

In my previous role, I was directly involved in developing and implementing cleaning validation protocols, conducting swab recovery studies, and ensuring compliance with regulatory standards. I utilized my strong understanding of analytical techniques to assess cleaning efficacy effectively.

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How do you prioritize tasks in a fast-paced laboratory environment?

I prioritize tasks by assessing deadlines and the impact of each task on the overall project timeline. I maintain a detailed schedule and adjust priorities based on immediate needs while keeping communication open with team members to ensure everyone is aligned.

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Can you describe a challenging problem you faced and how you solved it?

One challenging problem involved unexpected variability in swab recovery results. I conducted a root cause analysis, identified potential sources of error, and revised the testing protocols. By collaborating with my team, we implemented changes that significantly improved our data reliability.

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How do you ensure compliance with FDA regulations in your work?

I stay updated on FDA guidelines and apply them rigorously in all aspects of my work. I ensure that all validation protocols are created with compliance as a priority and regularly participate in audits to assess adherence to necessary standards.

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What approach do you take when analyzing data?

I believe in a structured approach to data analysis where I first summarize data points, identify trends, and visualize results. I cross-reference findings with existing literature and internal benchmarks to ensure robustness and accuracy in my conclusions.

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How do you handle constructive criticism from peers or supervisors?

I view constructive criticism as an opportunity for growth. I actively listen to feedback, reflect on it objectively, and take actionable steps to improve. I appreciate a collaborative environment where feedback is used to elevate the entire team's performance.

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What techniques do you use to communicate complex scientific information?

I focus on simplification and clarity when communicating complex information. Using visuals and relatable analogies helps convey my points effectively, ensuring that both technical and non-technical audiences can grasp key concepts.

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What role does teamwork play in your daily tasks?

Teamwork is essential in my role. I collaborate with various departments to ensure that our cleaning validation processes align with broader company goals. Open communication and shared objectives help enhance our overall productivity.

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How do you stay current with advancements in cleaning validation technology?

I regularly attend relevant seminars, webinars, and workshops. Subscribing to scientific journals and being part of professional organizations in the field also helps me remain informed and adapt the latest advancements in my work.

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Why do you want to work as a Scientist II/III at Serán BioScience?

Serán BioScience's commitment to innovation and quality aligns with my professional values. I am excited about the opportunity to contribute to meaningful projects that have a tangible impact on the pharmaceutical industry while working with a forward-thinking team.

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Startup Mindset
Collaboration over Competition
Growth & Learning
Inclusive & Diverse

At Serán, we utilize a science-first methodology and cutting-edge technologies to enable our healthcare customers to discover and develop innovative medicines that improve patient health.

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EMPLOYMENT TYPE
Full-time, on-site
DATE POSTED
December 3, 2024

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