method development scientist

Syngene International Limited

<div>
 Date: 14 Oct 2025
 
 
 Location:
 
 
 IN
 
 
 Division: Discovery Services
 
 
 
 Job Title: Junior Analytical Development Scientist - OSD
 
 
 
 
 Job Location: Bengaluru
 
 
 
 
 Department: DPA &ndash; FD
 
 
 
 
 About Syngene :
 
 Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.
 
 
 At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit
 
 
 
 Mandatory expectation for all roles as per Syngene safety guidelines
 
 
 
 <ul>
 <li>
 Overall adherence to safe practices and procedures of oneself and the teams aligned
 </li>
 <li>
 Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company&rsquo;s integrity &amp; quality standards
 </li>
 <li>
 Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
 </li>
 <li>
 Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
 </li>
 <li>
 Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
 </li>
 <li>
 Compliance to Syngene&rsquo; s quality standards at all times
 </li>
 <li>
 Hold self and their teams accountable for the achievement of safety goals
 </li>
 <li>
 Govern and Review safety metrics from time to time
 
 
 </li>
 </ul>
 
 Core Purpose Of The Role
 
 
 
 <ul>
 <li>
 Analytical development supporting Formulation development
 </li>
 <li>
 Routine analysis of samples
 </li>
 <li>
 Method development
 </li>
 <li>
 Instrument calibrations
 </li>
 <li>
 Documentation
 </li>
 <li>
 Report preparation
 </li>
 <li>
 Miscellaneous lab responsibilities
 
 
 </li>
 </ul>
 
 Role Accountabilities
 
 
 
 <ul>
 <li>
 Candidate should have very good educational and theoretical background.
 </li>
 <li>
 Candidate should have knowledge of calibration, method development and troubleshooting using various instruments like KF auto titrator, dissolution (I, II &amp; IV), spectroscopic instruments e.g. UV spectrometer, IR and Chromatographic instruments e.g. HPLC, GC
 </li>
 <li>
 Knowledge of various regulatory guidelines w.r.t. method development, product development and documentation
 </li>
 <li>
 Knowledge of method development for oral dosage forms w.r.t. tests like assay, degradation products, dissolutions, blend uniformity, content uniformity, cleaning method, etc.
 </li>
 <li>
 Knowledge of specification setting for oral dosage forms, in-process specifications as well as product specifications
 </li>
 <li>
 Knowledge and operating of instruments like LC-MS, GC-MS will be added advantage
 </li>
 <li>
 Good understanding of Documentation as per GxP requirements
 </li>
 <li>
 Online Lab notebook writing
 </li>
 <li>
 Method development report preparation &ndash; Assay, Degradation products, Dissolution, cleaning method, etc.
 </li>
 <li>
 Method of Analysis, Test report, SOP preparation
 </li>
 <li>
 Calibration documentation
 </li>
 <li>
 Review of documents generated by peers or juniors
 </li>
 <li>
 Should be able to search scientific literature on-line
 </li>
 <li>
 Should be a team player and able to coach juniors technically
 
 
 </li>
 </ul>
 
 Syngene Values
 
 
 
 All employees will consistently demonstrate alignment with our core values
 
 
 Excellence
 
 
 Integrity
 
 
 Professionalism
 
 
 
 Experience:
 
 More than 5 years up to 8 years
 
 
 
 Skills And Capabilities
 
 
 
 Candidate should have good proficiency for MS-office tools
 
 
 Should be able to search scientific literature on-line
 
 
 
 Behavioral Skills
 
 
 
 Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team.
 
 
 Good speaking-listening-writing skills, attention to details, proactive self-starter.
 
 
 Ability to work successfully in a dynamic, ambiguous environment.
 
 
 Ability to meet tight deadlines and prioritize workloads.
 
 
 Ability to develop new ideas and creative solutions.
 
 
 Should be able to work in team and flexible for working in shifts.
 
 
 Should be a focused employee.
 
 
 
 Education:
 
 M.Pharm / M.Sc
 
 
 
 Equal Opportunity Employer
 
 
 
 It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.
</div>

Junior Analytical Development Scientist - OSD

Vantive

<div>Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients&mdash; that is what Vantive aspires to deliver.
We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don&rsquo;t settle for the mediocre. Each of us is driven to help improve patients&rsquo; lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.
Vantive: A New Company Built on Our Legacy
Vantive built on our nearly 70-year legacy in acute therapies and home &amp; in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.
At Vantive, you will become part of a scientific community who are focused, courageous and don&rsquo;t settle for the mediocre. Each of us are driven to help improve patients&rsquo; lives worldwide. Join us as we revolutionize kidney care and other vital organ support therapies.
Job Title &ndash; Research Associate III, Analytical R&amp;D
Location &ndash; Whitefield, Bangalore
The candidate works with a group of scientists around the world to support Vantive&rsquo;s research and product development. The best-in-class laboratory will provide ample opportunities for learning and application of the latest analytical, scientific techniques. In this the scientist will establish the quality and safety of Vantive&rsquo;s drug products and devices by characterizing the potential risks associated with impurities like E&amp;L, nitrosamines, GTIs etc.
Essential Duties and Responsibilities<ul><li> Independently and successfully execute experiments towards method development, method validation, specifically for extractable and leachable profiling studies, within specified timelines.</li><li> Make sound technical recommendations in routine analytical activities. Provide analysis/redesign of key experimental procedures.</li><li> Produce scientific experimental data based on written procedures like method of analysis, protocols etc. Document laboratory work performed per Vantive&rsquo;s GDP.</li><li> Involve in and conduct trouble shooting of analytical methods, laboratory investigations etc. Identify root cause analysis and propose CAPA.</li><li> Review and approve the electronic raw data.</li><li> Participate in E&amp;L study design for Vantive&rsquo;s medical devices.</li><li> Interpret spectral data and help to identify the E&amp;L compounds.</li><li> Provide input to select analytical techniques and procedures to solve problems within area of responsibility.</li><li> Apply technical theories and principles to projects within area of expertise.</li><li> Independently analyze and propose solutions to research challenges. Learn newer analytical techniques to enhance the capability and productivity.</li><li> Author documents like Method of analysis/ protocols/ reports.</li><li> Review the reports for accuracy and adequacy.</li><li> Perform/ provide support as needed in calibration and maintenance of equipment in the laboratory.</li><li> Participate and take ownership of equipment installation and qualification activities as per Vantive&rsquo;s QMS.</li><li> Work according to appropriate quality standards and quality principles (e.g., Data Integrity, ALCOA)</li><li> Follow Vantive&rsquo;s Quality Manual, SOPs, and Environmental Health, Safety &amp; Sustainability (EHS&amp;S) guidelines in day-to-day activities, to ensure proactive compliance and continuous improvement.</li></ul>
Qualifications<ul><li> Hands-on experience in chromatographic and/ or spectral techniques like LC-MS/MS, GC-MS (including HRMS) and/or ICP-MS/ ICP-OES.</li><li> Operation of analytical tools/ instruments (weighing balances, pH meters etc.) and wet chemistry sample preparation techniques.</li><li> Working experience with ELN, electronic document repository system, Trackwise etc.</li><li> Should have analytical problem-solving skills, high learning agility, innovative experimental attitude along with good presentation skills.</li><li> Excellent written and verbal communication skills in English.</li><li> Demonstrates an inclusive attitude and an ability to collaborate with team members and cross-functional team members for project deliverables.</li><li> Ability to objectively assess, organize, and clearly communicate information.</li><li> Ability to interpret available information and make recommendations to resolve technical challenges.</li><li> Ability to appropriately prioritize work assigned to meet project deliverables in a timely manner.</li><li> Provide and accept critical feedback from others in a constructive manner.</li><li> Adapt to changes and have an agile mindset.</li><li> Embrace diversity and inclusion, value differences.</li></ul>
Education and/or Experience:<ul><li> Educational Qualification: Postgraduate/ Ph. D. in Pharmacy/ Chemistry or related field (M. Pharm./ M. Sc./ Ph. D.)</li><li> Professional Experience: 9 to 14 years of relevant experience</li></ul>
A Career That Matters
Vantive&rsquo;s employees are united in our mission Extending Lives and Expanding Possibilities. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our therapies and medical technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
Equal Employment Opportunity
Vantive is an equal opportunity employer. Vantive evaluates qualified applicants without regard to race, color, religion, gender, nationality, age, sexual orientation, gender identity or expression, disability/ handicap status or any other legally protected characteristics.
Reasonable Accommodation
Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link
Recruitment Fraud Notice 
 
Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.</div>

Research Associate III

Baxter International Inc.

<div>
 
 
 This is where&nbsp;
 
 your work makes a difference.
 
 
 At Baxter, we believe every person&mdash;regardless of who they are or where they are from&mdash;deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
 
 
 Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
 
 
 Here, you will find more than just a job&mdash;you will find purpose and pride.&nbsp;
 
 
 
 Summary:
 
 
 
 The new collaborator will be driving the success of Baxter's Reference Standard Global Program (RSGP) by leveraging their expertise in method development, method transfer, validations, stability studies, LIMS, and problem-solving capabilities, in close collaboration with a Contract Research Organization (CRO) partner.
 
 
 
 Essential Duties and Responsibilities
 
 
 
 
 Technical Expertise
 
 
 <ul>
 <li>
 Serve as a Technical lead for Reference Standard development and continued suitability studies, ensuring the highest quality and compliance.
 </li>
 <li>
 Develop, transfer, validate, and optimize analytical methods, leveraging expertise in laboratory operations and quality management.
 </li>
 <li>
 Manage documentation by ensuring compliance with quality standards, adhering to regulatory guidelines such as ICH, USP, and EP.
 
 
 </li>
 </ul>
 
 Scientific Analysis and Interpretation
 
 
 <ul>
 <li>
 Assess and interpret scientific data, presenting results in a clear, concise, and actionable manner.
 </li>
 <li>
 Collaborate with cross-functional teams to drive business decisions and optimize operational efficiency.
 
 
 </li>
 </ul>
 
 Leadership and Collaboration
 
 
 <ul>
 <li>
 Foster a culture of continuous improvement, applying best-demonstrated practices and seeking regular input and feedback from end users.
 </li>
 <li>
 Implement metrics to measure quality and on-time delivery, ensuring timely and effective completion of tasks to meet business milestones.
 
 
 </li>
 </ul>
 
 Professional Development and Network
 
 
 <ul>
 <li>
 Build a professional network within the Business Unit, across Units, and outside of Baxter, driving collaboration and knowledge sharing.
 </li>
 <li>
 Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements, performing risk/benefit analysis for project identification and prioritization.
 
 
 </li>
 </ul>
 
 Quality and Compliance
 
 
 <ul>
 <li>
 Adhere to the Quality System, understanding and applying applicable corporate, divisional, and departmental procedures to ensure compliance and quality standards.
 </li>
 <li>
 Demonstrate a commitment to quality and compliance, driving a culture of excellence and continuous improvement.
 
 
 </li>
 </ul>
 
 Technical and interpersonal expertise
 
 
 <ul>
 <li>
 Proven background in a range of analytical techniques, including: HPLC, GC, LC, KF, MS, FTIR, NMR etc.,
 
 
 </li>
 </ul>
 <ul>
 <li>
 Excellent communication skills, with the ability to effectively convey complex information to various stakeholders.
 </li>
 <li>
 Strong negotiation skills, with the ability to influence others internally and externally.
 
 
 </li>
 </ul>
 <ul>
 <li>
 In-depth knowledge of quality and general business systems, including:
 <ul>
 <li>
 Quality management systems (QMS)
 </li>
 <li>
 Project management methodologies
 
 
 </li>
 </ul>
 </li>
 <li>
 Ability to analyze and solve complex problems through innovative thinking and experience.
 
 
 </li>
 </ul>
 <ul>
 <li>
 Strong technical skills, with experience in:
 <ul>
 <li>
 Reviewing study protocols and reports
 </li>
 <li>
 Managing technical packages and associated documents
 </li>
 <li>
 Handling stability studies using LIMS
 
 
 </li>
 </ul>
 </li>
 <li>
 Ability to analyze and interpret complex data, with a focus on delivering high-quality results.
 </li>
 <li>
 Self-motivated and proactive, with excellent interpersonal skills and a strong ability to work independently.
 </li>
 <li>
 Proficient in project management tools and techniques, with a focus on delivering results in a timely and efficient manner.
 
 
 </li>
 </ul>
 
 Educational Qualification
 
 
 <ul>
 <li>
 Ph.D. in Analytical / Organic chemistry or Pharmaceutical sciences with a minimum of 3 years or Master in Analytical / Organic chemistry or Pharmaceutical sciences with more than 6 years of experience.
 </li>
 <li>
 Experience in Project management and CRO collaboration is an added advantage.
 
 
 </li>
 </ul>
 
 Equal Employment Opportunity
 
 
 
 Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
 
 
 
 Reasonable Accommodations
 
 
 
 Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
 
 
 
 Recruitment Fraud Notice
 
 
 
 
 Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
 
 
</div>

Assoc Scientist I

Baxter

<div>This is where your work makes a difference.
At Baxter, we believe every person&mdash;regardless of who they are or where they are from&mdash;deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job&mdash;you will find purpose and pride.
Summary:
The new collaborator will be driving the success of Baxter's Reference Standard Global Program (RSGP) by leveraging their expertise in method development, method transfer, validations, stability studies, LIMS, and problem-solving capabilities, in close collaboration with a Contract Research Organization (CRO) partner.
Essential Duties and Responsibilities
Technical Expertise<ul><li>
Serve as a Technical lead for Reference Standard development and continued suitability studies, ensuring the highest quality and compliance.</li><li>
Develop, transfer, validate, and optimize analytical methods, leveraging expertise in laboratory operations and quality management.</li><li>
Manage documentation by ensuring compliance with quality standards, adhering to regulatory guidelines such as ICH, USP, and EP.</li></ul>
Scientific Analysis and Interpretation<ul><li>
Assess and interpret scientific data, presenting results in a clear, concise, and actionable manner.</li><li>
Collaborate with cross-functional teams to drive business decisions and optimize operational efficiency.</li></ul>
Leadership and Collaboration<ul><li>
Foster a culture of continuous improvement, applying best-demonstrated practices and seeking regular input and feedback from end users.</li><li>
Implement metrics to measure quality and on-time delivery, ensuring timely and effective completion of tasks to meet business milestones.</li></ul>
Professional Development and Network<ul><li>
Build a professional network within the Business Unit, across Units, and outside of Baxter, driving collaboration and knowledge sharing.</li><li>
Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements, performing risk/benefit analysis for project identification and prioritization.</li></ul>
Quality and Compliance<ul><li>
Adhere to the Quality System, understanding and applying applicable corporate, divisional, and departmental procedures to ensure compliance and quality standards.</li><li>
Demonstrate a commitment to quality and compliance, driving a culture of excellence and continuous improvement.</li></ul>
Technical and interpersonal expertise<ul><li>
Proven background in a range of analytical techniques, including: HPLC, GC, LC, KF, MS, FTIR, NMR etc.,</li></ul><ul><li>
Excellent communication skills, with the ability to effectively convey complex information to various stakeholders.</li><li>
Strong negotiation skills, with the ability to influence others internally and externally.</li></ul><ul><li>
In-depth knowledge of quality and general business systems, including:<ul><li>
Quality management systems (QMS)</li><li>
Project management methodologies</li></ul></li><li>
Ability to analyze and solve complex problems through innovative thinking and experience.</li></ul><ul><li>
Strong technical skills, with experience in:<ul><li>
Reviewing study protocols and reports</li><li>
Managing technical packages and associated documents</li><li>
Handling stability studies using LIMS</li></ul></li><li>
Ability to analyze and interpret complex data, with a focus on delivering high-quality results.</li><li>
Self-motivated and proactive, with excellent interpersonal skills and a strong ability to work independently.</li><li>
Proficient in project management tools and techniques, with a focus on delivering results in a timely and efficient manner.</li></ul>
Educational Qualification<ul><li>
Ph.D. in Analytical / Organic chemistry or Pharmaceutical sciences with a minimum of 3 years or Master in Analytical / Organic chemistry or Pharmaceutical sciences with more than 6 years of experience.</li><li>
Experience in Project management and CRO collaboration is an added advantage.</li></ul>
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Reasonable Accommodations 
 
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice 
 
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.</div>

LanceSoft, Inc.

<div>
 
 
 Job Title: Analytical Chemist
 
 
 
 
 Location: Andover, MA 01810
 
 
 
 
 Duration: 18 Months
 
 
 
 M-F, onsite Andover, 1st shift
 
 
 
 
 
 
 Skill
 
 
 
 
 Last Used
 
 
 
 
 No. of Years of Experience
 
 
 
 
 Capillary electrophoresis
 
 
 
 
 GC - MS
 
 
 
 
 Method qualification
 
 
 
 
 UHPLC
 
 
 
 
 
 
 
 
 Job Description (Required):
 
 
 <ul>
 <li>
 This opportunity provides analytical support to internal process development groups. The position will work with a number of different analytical techniques that will include UPLC, HPLC, GC, and CE.
 </li>
 <li>
 If applicable, analytical research and development activities will include literature searches, analytical method development, test procedure writing, analytical method qualification and method transfer.
 </li>
 <li>
 Analyzes early-stage lab samples, pilot plant samples, production samples, in=process samples and CRO samples.
 </li>
 <li>
 Possesses extensive knowledge of various laboratory instruments like U/HPLC, GC, and CE.
 </li>
 <li>
 BSc with at least 5+ years relevant experience
 </li>
 <li>
 MSc with at least 2+ years relevant experience
 </li>
 </ul>
 
 
 
 
 
 Notes:
 
 
 
 Scientist
 
 <ul>
 <li>
 looking for someone to jump right in, hands on exp.
 </li>
 </ul>
 
 looking for someone very familiar and comfortable with HPLC, GC
 
 <ul>
 <li>
 M-F, onsite Andover, 1st shift
 </li>
 <li>
 Pharma preferred, Mix of academic and industry is good too
 </li>
 </ul>
 
 
 
 
 
 Interview: Onsite
 
 
</div>

Analytical Chemist

Tap Growth ai

<div>
 
 🌟 We're Hiring: Scientist! 🌟
 
 
 
 We are seeking a dedicated and analytical Scientist to join our research team and contribute to groundbreaking scientific discoveries. The ideal candidate will have a strong foundation in scientific methodology, data analysis, and research techniques to support our innovative projects and drive scientific excellence.
 
 
 
 📍 Location:
 
 Durham, United States
 
 
 
 ⏰ Work Mode:
 
 Work From Office
 
 
 
 💼 Role:
 
 Scientist
 
 
 
 Pay Scale:
 
 Up to $98, 404.80 (Dependent on Experience)
 
 
 
 What You'll Do
 
 
 
 Laboratory Data Review:
 
 
 <ul>
 <li>
 Scientific data review of laboratory documentation and data to appropriate standards (GMPs, SOPs, protocols, methods).
 </li>
 <li>
 Good understanding of data integrity and ALCOA+ (Attributable, Legible, Contemporaneous, Original, and Accurate) principles.
 </li>
 <li>
 Peer review of results and documentation of product development studies including statistical data reports (JMP).
 </li>
 <li>
 Peer review of method validations and analytical technical transfers.
 </li>
 <li>
 Transcription checking of regulatory submissions, reports, and / or JMP tables / plots.
 
 
 </li>
 </ul>
 
 What We're Looking For
 
 
 
 <ul>
 <li>
 BS or MS in Chemistry, Pharmaceutical Sciences, or a similar applicable discipline.
 </li>
 <li>
 Experience with HPLC in a GMP / QC setting, Empower software preferred.
 </li>
 <li>
 Experience with Inhalation testing products, large and small molecule preferred.
 </li>
 <li>
 Strong understanding of GMP and FDA guidelines for pharmaceutical manufacturing and validation.
 </li>
 <li>
 Strong organizational skills for managing multiple priorities.
 </li>
 <li>
 Effective communication and interpersonal skills for coordination with lab personnel, and management.
 
 
 </li>
 </ul>
 
 
 Ready to advance science? 🚀 Apply now and let's innovate together!
 
 
</div>

Scientist

Novel Microdevices

<div>Position Title: Staff Scientist &ndash; Assay Development, Quality, and Manufacturing Support 
Department: R&amp;D / Quality / Manufacturing 
Reports To: VP of Assay Development and Chief Operating Officer 
Position Summary

The Scientist will play a key role in supporting the development, validation, and manufacturing of Novel Microdevices&rsquo; molecular diagnostic assays and reagents. This cross-functional position bridges R&amp;D, Quality Control, and Manufacturing, ensuring that new assays and production lots meet performance, consistency, and regulatory requirements.

The ideal candidate is a hands-on scientist who enjoys both bench-level experimentation and structured quality processes, thrives in a fast-paced startup environment, and contributes to the continuous improvement and commercialization of diagnostic products. 

Key Responsibilities
<ul>
<li>Assay Development &amp; Verification
<ul><li>Support R&amp;D in the design, optimization, and verification of new molecular diagnostic assays (e.g., qPCR, nucleic acid extraction, reagent formulation).</li>
<li>Conduct feasibility, design transfer, and V&amp;V (Verification &amp; Validation) testing to ensure product performance and regulatory compliance.</li>
<li>Perform analytical testing to assess assay sensitivity, specificity, reproducibility, and robustness.</li>
<li>Analyze, interpret, and present experimental data to cross-functional teams.</li>
</ul>Reagent &amp; Manufacturing Support
<ul><li>Collaborate with Manufacturing to scale reagent formulations, optimize processes, and ensure lot-to-lot consistency.</li>
<li>Conduct in-process, release, and stability testing on raw materials, intermediates, and finished products.</li>
<li>Develop and refine SOPs, batch records, and test methods for reagent preparation and product release.</li>
<li>Support troubleshooting of reagent production issues and contribute to process improvements.</li></ul> 
 
<ul><li>Execute and document QC methods in compliance with ISO 13485, FDA 21 CFR Part 820, and IVDR standards.</li>
<li>Support method validation, transfer, and verification in alignment with CLSI and internal quality requirements.</li>
<li>Participate in investigations of nonconformances, OOS/OOT events, and CAPA development.</li>
<li>Ensure accurate and complete documentation consistent with design control, traceability, and QMS standards.</li>
</ul>Cross-Functional Collaboration
<ul><li>Work closely with QA, R&amp;D, and Operations to support technology transfer and readiness for scale-up.</li>
<li>Provide technical input for product characterization, design reviews, and risk assessments (ISO 14971).</li>
<li>Train and mentor laboratory staff on analytical methods, data integrity, and best practices.</li>
</ul>Contribute to continuous improvement initiatives to strengthen product performance and operational efficiency.</li></ul> 


Minimum Qualifications
<ul>
<li>PhD or Master&rsquo;s degree in Molecular Biology, Biochemistry, Biotechnology, or a related life science field, or equivalent experience in assay development or molecular diagnostics; with at least 2 years of relevant experience; 
OR 
Bachelor&rsquo;s degree in a related discipline with at least 5 years of relevant experience in assay development, molecular biology, or quality control within a regulated IVD or life sciences environment.</li>
<li>Hands-on experience with qPCR and molecular assay techniques, including nucleic acid extraction, amplification, or detection.</li>
<li>Working knowledge of ISO 13485, FDA 21 CFR Part 820, or similar quality management systems.</li>
<li>Strong experimental design, troubleshooting, and data analysis skills.</li>
<li>Excellent documentation, organization, and communication skills with a proven ability to collaborate across R&amp;D, Manufacturing, and QA/QC.</li></ul> 


Preferred Qualifications
<ul>
<li>Experience in IVD assay development and design transfer from prototype to production.</li>
<li>Familiarity with reagent formulation, lyophilization, or stability studies.</li>
<li>Prior involvement in V&amp;V studies, design control documentation, or regulatory submissions.</li>
<li>Knowledge of statistical tools for data trending and method validation (e.g., JMP, Minitab, or equivalent).</li>
<li>Exposure to risk management (ISO 14971) and document control systems.</li></ul></div>

Staff Scientist – Assay Development, Quality, and Manufacturing Support

Search 10000+ Method development scientist jobs near you this October. New roles added regularly across leading industries. Apply today.

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