bioanalytical scientist

Thermo Fisher Scientific

<div>Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
This is a fully remote role supporting one of our key customers. We welcome applicants from all locations within the US.
Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.
Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission &ndash; to enable our customers to make the world healthier, safer, and cleaner.
Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.
The Research Scientist acts as the sponsor representative/study monitor for one or more studies and supports the bioanalytical study phases of clinical trials.
Key responsibilities:<ul><li>
Reviews trial related documentation with a link to the GxP vendor (i.e., CTP, SAP, TLF&rsquo;s, CSR, Lab manual)</li><li>
Ensures the bioanalytical vendor receives copies of trial related documentation and relevant amendments (e.g., clinical trial protocol)</li><li>
Reviews and approves study plans of bioanalytical phases of clinical trials</li><li>
Reviews and approves (if applicable) bioanalytical reports</li><li>
Oversees planned and unplanned changes to study plan and vendor procedures are documented according to vendor procedures (e.g., in amendments and deviations) and are shared with the sponsor as stipulated in the quality agreement or communication plan</li><li>
Ensures that the Clinical Trial Team is adequately informed of the project status and that relevant information (e.g., end-of-study timelines and data delivery requirements) from the Clinical Trial Team is conveyed to the project manager and bioanalytical vendor</li><li>
Escalates issues related to timelines, budget or communication to the appropriate stakeholders</li><li>
Manages oversight documentation in eTMF</li><li>
Contributes to interactions with regulatory agencies (if applicable)</li></ul>
Education and Experience:<ul><li><ul><li>PhD in Immunology or Molecular Biology and previous experience in the field of life sciences that provides the knowledge, skills, and abilities to perform the job comparable to 3+ years</li></ul></li><li>
OR</li><li>
Master&rsquo;s Degree and previous experience in the field of life sciences that provides the knowledge, skills, and abilities to perform the job comparable to 6+ years</li></ul>
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:<ul><li>
Experience in managing outsourced activities at external vendors required</li><li>
Strong knowledge of bioanalytical techniques specifically in biologics and antibodies assays required &middot; Experience performing PK and ADA assays required</li><li>
Experience in analyzing human samples in support of clinical trials required</li><li>
Strong understanding of GCP/GCLP guidelines and other current global regulations required</li><li>
Experience with submission documentation and regulatory interactions</li><li>
Experience with clinical immunogenicity data interpretation, writing and reviewing the Integrated Summary of Immunogenicity (ISI) and clinical study report</li><li>
Experience drafting and reviewing bioanalytical modules (2.7.1, 2.7.2) and immunogenicity sections in regulatory documents either independently or collaboration with a medical writer</li></ul>
Working Environment:
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:<ul><li>
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.</li><li>
Able to work upright and stationary for typical working hours.</li><li>
Ability to use and learn standard office equipment and technology with proficiency.</li><li>
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.</li></ul></div>

Research Scientist PI - Bioanalytical

Labcorp

<div>At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations.
We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. We put our trust in science and in one another. This is your chance to become part of a team that helps to bring the miracles of medicine to market sooner, as Labcorp Drug Development has helped pharmaceutical and biotech companies develop one-third of all prescription medicines on the market today.
We are seeking a LC/MS Validation Scientist III to join our Bioanalytical team in Indianapolis, IN. As a Validation Scientist III, you will perform method validation, method update and stability testing using a variety of analytical techniques in compliance with standard operating procedures (SOPs) and regulatory agency guidelines. In addition, you will provide downstream support of methods to associated groups and serve as a bioanalytical resource to the broader business.
Duties and Responsibilities:<ul><li>
Organize and perform routine to advanced level of method validation/testing (and all associated activities) with independence and efficiency in compliance with appropriate SOPs and regulatory agency guidelines.</li><li>
Display advanced data interpretation and analytical instrumentation skills and respond to difficult procedural, technical, and quality questions with minimal guidance.</li><li>
Assist in writing and review of reports, methods, protocols, and SOPs and maintain complete study documentation in compliance with regulatory guidelines (e.g. GLP and GCP) and department processes.</li><li>
Inform Lead Scientist and/or management of any problems and/or deviations that may affect the integrity of the data and recommend corrective action.</li><li>
Write and review training materials and deliver training/mentorship of staff in relevant techniques, procedures and provide expert advice on training requirements.</li><li>
Support communications with external clients and other team members.</li><li>
Participate in new equipment, instrument and methodology assessment and qualifications.</li><li>
Demonstrate advanced time management skills and manages work on multiple assigned projects in a given week, and liaise and coordinate work activities with team members in order to deliver data.</li><li>
Support others in their duties to ensure all scheduled operational activities are completed on each given day by effective and concise communication with team members, and ability to listen and discuss ideas in an open and professional manner.</li><li>
Participate in process improvement initiatives.</li></ul>
Education/Experience:<ul><li>
Bachelor&rsquo;s Degree in Life Sciences, Pharmaceutical science or Chemistry with 3 years of relevant work experience or Master&rsquo;s Degree with at least 1 year of relevant work experience in LC/MS method validation</li><li>
Excellent communication and interpersonal skills</li><li>
Proven ability to prioritize and manage time.</li><li>
Excellent attention to detail</li><li>
Able to utilize word processing, database, spreadsheet, and specialized software.</li><li>
Work experience in GLP/GCP environment is a plus</li></ul>
Application Window: 12/30/2025 thru 1/5/2026
Pay Range: $69k - $81k annually
All job offers will be based on a candidate&rsquo;s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.
Benefits:
Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN &amp; Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here.
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.</div>

LCMS Validation Scientist III

BioAgilytix Labs

<div><div>At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You&rsquo;ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.</div>
<h3 class="jobSectionHeader">Essential Responsibilities</h3><ul><li>
Run assays independently</li><li>
Adhere to provided method/directive</li><li>
Prepare buffers</li><li>
Use LIMS system</li><li>
Participate in sample analysis</li><li>
Pipetting</li><li>
Adhere to safety requirements
</li><li>Keep accurate inventory of supplies for assays</li><li>
Responsible for accurate record keeping with regard to sponsor's samples, data, and reports (documentation according to GxP guidelines)</li></ul><h3 class="jobSectionHeader">
Additional Responsibilities</h3><ul><li>
Other duties as needed</li></ul><h3 class="jobSectionHeader">
Minimum Preferred Qualifications: Education/Experience</h3><ul><li>
field; or equivalent experience in a scientific environment with more than two (2) years' experience in a scientific laboratory environment; or</li><li>
Bachelor's degree in molecular biology, biochemistry, immunology, biotechnology, or related field with one (1) year experience in a scientific laboratory environment</li></ul><h3 class="jobSectionHeader">
Minimum Preferred Qualifications: Skills</h3><ul><li>
Ability to carry out routine tasks accurately, following strict methodology to carry out analysis, preparing samples and maintaining and operating standard laboratory equipment.</li><li>
Must work effectively within team to meet objectives under time constraints</li><li>
Ability to take direction well and multi-task</li><li>
Detail oriented and highly organized</li><li>
Experience working in a GxP environment preferred</li><li>
Excellent oral and written communication skills</li><li>
Proficient in the use of MS Excel and Word</li></ul><h3 class="jobSectionHeader">
Supervisory Responsibility</h3><ul><li>
This position has no supervisory responsibilities</li></ul><h3 class="jobSectionHeader">
Supervision Received</h3><ul><li>
Frequent supervision and instructions</li><li>
Infrequently exercises discretionary authority</li></ul><h3 class="jobSectionHeader">
Working Environment</h3><ul><li>
Primarily laboratory environment</li><li>
Exposure to biological fluids with potential exposure to infectious organisms</li><li>
Rare exposure to skin and lung irritants, toxic materials, and hazardous waste</li><li>
Personal protective equipment required, such as protective eyewear, garments, and gloves</li><li>
Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets</li></ul><h3 class="jobSectionHeader">
Physical Demands</h3><ul><li>
Ability to work in an upright and/or stationary position for up to eight (8) hours per day</li><li>
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment</li><li>
Frequent mobility needed</li><li>
Frequent crouching, stooping, with frequent bending and twisting of upper body and neck</li><li>
Light to moderate lifting and carrying (or otherwise moves) objects, including laboratory equipment, laboratory supplies, and laptop computer, with a maximum lift of 20 pounds</li><li>
Ability to access and use a variety of computer software
</li><li>Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences</li><li>
Frequently interacts with others to obtain or relate information to diverse groups</li><li>
Requires multiple periods of intense concentration</li><li>
Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence</li><li>
Ability to perform under stress and multi-task</li><li>
Regular and consistent attendance</li></ul><h3 class="jobSectionHeader">
Position Type and Expected Hours of Work</h3><ul><li>
This is a full-time position</li><li>
Some flexibility in hours is allowed, but the employee must be available during the &ldquo;core&rdquo; work hours as published in the BioAgilytix Employee Handbook</li><li>
Occasional weekend, holiday, and evening work required</li></ul><div>
The hourly pay range listed above reflects BioAgilytix's hiring range for this position.</div><div>
BENEFITS AND OTHER PERKS</div><div>
Medical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability \u007C Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Parental Leave, Paid Holidays (9 scheduled; 5 floating), 401k with Employer Match, Employee Referral Program</div><div></div><div> 
COMMITMENT TO EQUAL OPPORTUNITY</div><div>
BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.</div>

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.</div>

Analyst I - LC-MS

ONE NUCLEUS

3 Month Contract Near Cambridge UK Scientist / Bioanalytics, PK assays, MSD Candidates will need to be available to start quickly, be able to be based in Cambridge, have right to work in the UK and have experience with the above techniques. Some training could be given to certain areas lacking. Please send CV's direct via LinkedIn to Louisa Hodgson in the first instance and for suitable candidates she will organise a call to discuss more insight. This role will support a leader in a time of need, so if you can confidently help us with the above then we would welcome hearing from you with your CV. Candidates without the immediate right to work in the UK unfortunately cannot be considered.

Scientist / Bioanalytics, PK assays, MSD

<div>Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
How will you make an impact?
 
You'll perform sophisticated analyses to ensure product quality and safety in our laboratories. As a QC Scientist II, you'll conduct complex analytical testing to support GMP manufacturing of biopharmaceutical products, from early-stage clinical development through commercial release. You'll work with analytical instruments and technologies while making a meaningful impact on patient health through precise quality control testing. 
 
Working with cross-functional teams, you'll execute validated test methods, participate in method development and validation activities, investigate out-of-specification results, and maintain detailed documentation of analyses. You'll contribute to continuous improvement initiatives and help establish robust analytical processes while adhering to cGMP requirements and safety standards.
We have 2 positions available.
A Day in the Life:<ul><li>
Perform testing on In-Process, DS release, DP release, DS stability, DP Stability, and various other non-routine samples, ensuring timely delivery for projects</li><li>
Participate in analytical method validation/transfer, method establishment/qualification routine and stability analysis.</li><li>
Conduct GMP testing in an analytical laboratory environment using Separation Techniques, BioAssay Analysis and Compendia test methods (i.e. Reverse Phase, SEC, Titer concentration, iCE, pH, Osmolarity, Residual DNA, Appearance)</li><li>
Compiles data for documentation of test procedures, prepares reports. Ensures all testing processes, monitoring, and departmental documentation meet SOPs and cGMP regulatory standards.</li><li>
Participate in the development of new concepts, techniques, and standards. Involved with assisting in the preparation of CoAs.</li><li>
Recognize and report out-of-specification/ out-of-trend results to laboratory management; recommend solutions.</li><li>
Perform all duties in compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines</li><li>
Partake in laboratory activities, including safety inspections and client audits in a timely matter.</li></ul><div>
Keys to Success: 
<ul><li>Advanced degree with no prior experience, or Bachelor's degree with 2 years of experience in a GMP regulated laboratory environment performing analytical testing</li><li>Preferred Fields of Study: Chemistry, Biology, Biochemistry, or related scientific field</li><li>Expertise in analytical techniques such as HPLC, GC, CE, ELISA, PCR, and other bioanalytical methods</li><li>Proficient in aseptic techniques and environmental monitoring procedures</li><li>Strong knowledge of cGMP regulations and quality control requirements</li><li>Experience with laboratory information management systems (LIMS) and quality management systems</li><li>Excellent documentation practices and attention to detail</li><li>Strong problem-solving and analytical skills</li><li>Ability to work both independently and collaboratively</li><li>Proficiency with Microsoft Office applications</li><li>Strong written and verbal communication skills</li><li>Ability to lift up to 30 pounds and stand for extended periods</li><li>Willingness to wear required PPE including lab coat, safety glasses, and gloves</li><li>May require flexible scheduling including occasional weekend work</li><li>Experience with method validation and transfer activities preferred</li><li>Knowledge of data integrity requirements and good documentation practices</li><li>Demonstrated ability to investigate out-of-specification results and author technical reports</li></ul></div>
Excellent Benefits<ul><li>
Benefits &amp; Total Rewards | Thermo Fisher Scientific</li><li>
Medical, Dental, &amp; Vision benefits-effective Day 1</li><li>
Paid Time Off &amp; Designated Paid Holidays</li><li>
Retirement Savings Plan</li><li>
Tuition Reimbursement</li></ul>
OTHER<ul><li>
Relocation assistance is NOT provided</li><li>
Must be legally authorized to work in the United States now or in the future, without sponsorship.</li><li>
Must be able to pass a comprehensive background check, which includes a drug screening</li></ul></div>

QC Scientist II

Sepax Bioscience, Inc.

This individual must be a self-motivated, detail oriented and energetic scientific person. This position is entry&shy; level in the IEX department and based at our headquarter office located in Newark, Delaware.Requirements:&middot; Bachelor&rsquo;s degree in chemistry or related field.&middot; 1-2 years laboratory/research work experience.&middot; Self-motivated, willingness to learn different instruments and techniques, positive attitude, work well in a group environment, and able to work with minimal supervision.&middot; Good understanding of basic principles and mechanisms of material chemistry, organic chemistry, and chemical synthesis.&middot; Familiar with HPLC instrumentation and different LC separation techniques or chemical characterization is a plus.&middot; Good organizational skills and ability to multi-task.&middot; Good analytical, problem-solving, and attention-to-detail skills.&middot; Ability to communicate results of experiments through proper record keeping.Responsibilities:&middot; Perform a variety of resin syntheses under supervision.&middot; Technical procedures such as preparing routine solutions and reagents to support the chemistry experiments.&middot; Characterize the synthesized resin with SEC, IR and chromatographic measurements.&middot; Provide lab support and assist in research and development of new materials.&middot; Performance of general housekeeping maintenance in the laboratory and cleanliness in work areas.&middot; Observe safety precautions as outlined in safety manuals and training.Company Overview: Sepax is a fast-growing technology company and has emerged as a leader in the biological separation industry. Sepax has been developing a wide range of intellectual properties in the areas of particle synthesis, surface modification, LC column packing, bulk media production and purification process development. Sepax Technologies, Inc. focuses on three business areas: 1) bioanalytical solutions, 2) solution-based process purification and 3) medical diagnostics. Sepax Quality Management System is ISO 9001:2015 certified. Sepax Technologies Inc. is an Equal Opportunity Employer.Sepax Technologies Inc. is an Equal Opportunity Employer.Please submit all cover letters &amp; resumes to hr@sepax-tech.comPay: $47,840.00 - $64,064.00 per yearBenefits:<ul><li>401(k)</li><li>Dental insurance</li><li>Health insurance</li><li>Life insurance</li><li>Paid time off</li><li>Vision insurance</li></ul>Ability to Commute:<ul><li>Newark, DE 19711 (Preferred)</li></ul>Work Location: In person

Associate Chemist R&D

Talentxo

Data Scientist (Product Company) &ndash; MumbaiWe are hiring a Data Scientist for a consumer internet product company in Mumbai. This role focuses on building, deploying, and scaling ML models that directly impact product performance and user outcomes.Required Experience: 2&ndash;5 yearsYou must have:<ul><li>2+ years hands-on experience as a Data Scientist or ML Engineer building ML models end-to-end</li><li>Strong Python with ability to implement classical ML algorithms (regression, trees, boosting, etc.)</li><li>Experience in minimum 2+ use cases among recommendation systems, image data, fraud/risk detection, price modelling, propensity models</li><li>Strong NLP exposure (text gen/classification, embeddings, similarity, user profiling, feature extraction from unstructured text)</li><li>Practical experience productionizing models using APIs / CI/CD / Docker on AWS or GCP</li><li>Product company experience only (not financial domains)</li></ul>What you will work on: Recommendation &amp; ranking, personalization, fraud/risk, pricing models, churn/propensity, A/B test design, monitoring model &amp; data drift.Location: Mumbai, Maharashtra Working Days: 5 days/week Outstation Candidates: Allowed if willing to relocate Max Notice Period: 30 daysJob Type: Full-timePay: ₹2,100,000.00 - ₹2,800,000.00 per yearExperience:<ul><li>Data Scientist or ML Engineer: 2 years (Required)</li></ul>Work Location: In person

Data Scientist

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