Senior Associate Scientist, Discovery Bioanalytical 1

Charles River Laboratories, Research Models and Services, Germany GmbH; Michigan; On-site; USD 75,000; Full time

Job summary

A leading company in drug development seeks a Senior Associate Scientist for its Discovery Bioanalytical team in Mattawan, MI. The role involves analyzing drug substances using advanced LC/MS/MS techniques, developing methodologies, and ensuring adherence to regulatory standards. Candidates should possess a relevant degree and experience in LC/MS analysis.

Qualifications

• 5-7 years relevant experience for Bachelor's, 2-4 for Master's, or 1-2 for Doctorate.
• Ability to learn software systems and work within regulatory frameworks.

Responsibilities

• Perform quantitative analysis of drugs in body fluids and tissue.
• Develop and validate LC/MS/MS methods and procedures.
• Document methods and results for inclusion in study reports.

Skills

LCMS Experience

Communication

Critical Thinking

Problem Solving

Education

Bachelor's degree (BS)

Master's degree (MS)

Doctorate degree (PhD)

Tools

Microsoft Office Suite

Job description

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

Job Summary

We are seeking a Senior Associate Scientist for our Discovery Bioanalytical team at our Mattawan, MI site.

The Senior Associate Scientist in Discovery Bioanalytical is responsible for quantitative analysis of drug in body fluids and tissue from non-regulated and regulated safety evaluation, pharmacokinetic/pharmacodynamic studies. Staff participate in the development and validation of quantitative LC/MS/MS methodology, sample analysis, and interpretation & reporting of data utilizing validated hardware and software systems. This includes the development of sample extraction techniques and employment of laboratory robotics to enhance delivery time of bioanalytical data. Staff are also knowledgeable in the application of GxP's and applicable SOPs, along with adhering to study protocols to accurately document methods, procedures, and results for inclusion into study reports and regulatory documents.

The fundamental Competencies/Skills& Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed:

• Efficiently perform and document all procedures and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.)
• Actively communicate and collaborate across operational areas in order to adhere to timelines and produce quality data.
• Assist with laboratory investigations, assay troubleshooting, quality observations, and problem solving of technical and/or regulatory issues with minimal oversight.
• Effectively develop and validate quantitative/qualitative LC/MS-MS methods/procedures with limited complexity/scope in one operational area with minimal oversight.
• Independently perform data analysis in appropriate software for at least one analytical platform with minimal oversight.
• Independently operate laboratory instruments including their respective software applications for 1-2 analytical platforms with minimal oversight.
• Develop critical thinking, troubleshooting and time management skills aligned with needs of operational areas.
• Demonstrate effective communication skills through informal discussions with peers, supervisor, and team.
• Able to recognize method and/or data issues and communicate them to management to minimize study impact with minimal oversight.
• Independently prepare summary of method development data
• Write both study and non-study deviations with minimal oversight.
• Full understanding of regulatory and GXP requirements, industry standards and company SOPs within one operational area
• Independently lead the lab staff in the completion of method validation studies
• Provide support to staff members as required by operational area as needed.
• Actively participate in internal process improvements, presentations, and harmonization efforts
• Performs all other related duties as assigned.

The pay for this position is $75,000 annually USD. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Job Qualifications

The following are the minimum requirements related to the Senior Associate Scientist position.

• Bachelor's degree (BS) with 5-7 years of relevant working experience or Master's degree (MS) with 2-4 years of relevant work experience or Doctorate degree (PhD) with 1-2 year of relevant experience
• An equivalent combination of relevant education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• LCMS Experience Required
• Ability to communicate verbally and in writing at all levels inside and outside the organization.
• Basic familiarity with Microsoft Office Suite
• Computer skills, commensurate with Essential Functions, including the ability to learn a validated system.
• Ability to work extended hours beyond normal work schedule to include, but not limited to evenings, weekends, extended shifts, and/or extra shifts, sometimes on short notice.
• Ability to work under specific time constraints.
• This is an onsite position (no remote options) requires no travel.

Competencies

Lead - We lead when we advocate our purpose and model our values, when we deliver innovation, when we embrace change, and when we appreciate and celebrate the great work of others.

Care - We show we care when we respect each other, our animals and the communities where we work and live, when we create a positive healthy workplace, when we are mindful of our compliance standards, and when we choose to do the right thing.

Collaborate -We collaborate when we partner with each other and promote teamwork, when we communicate clearly and effectively across the hall or around the globe, and when we welcome all forms of diversity and encourage inclusiveness.

Own - We act like owners when we hold ourselves accountable for our actions, when we respond to internal and external client needs with speed and accuracy, when we set and achieve meaningful goals, and when we strive towards continuous improvement.

About Safety Assessment
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.

About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to [e-mail]. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit www.criver.com.

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