biopharmaceutical scientist

Syngene International Limited

<div>
 Date: 18 Dec 2025
 
 
 Location:
 
 
 Bangalore, KA, IN, 560099
 
 
 Division: Development Services
 
 
 
 Job Description
 
 
 
 Designation: Formulation Scientist
 
 
 Job Location: Bangalore
 
 
 The Company
 
 
 Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene&rsquo;s 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.
 
 
 Key Result Areas
 
 
 
 Role-specific
 
 
 
 
 Functional Responsibilities:
 
 
 
 <ul>
 <li>
 Design and develop parenteral formulations for complex biologics
 </li>
 <li>
 Execute pre-formulation studies of biologics through rational design principles including structure function assessment, buffer/excipient/stabilizer screening, etc.
 </li>
 <li>
 Plan and execute drug substance/product stability studies, analyze data trend and support assessment of degradation kinetics and assign shelf-life.
 </li>
 <li>
 Author protocols, technical reports and communicate studies outcome to cross-functional groups.
 
 
 </li>
 </ul>
 
 Primary Responsibilities
 
 
 
 <ul>
 <li>
 Should have a strong background in Biologics Parenteral Formulation development including solid and liquid dosage forms
 </li>
 <li>
 Experience in both early and late formulation development of mAbs and fusion proteins
 </li>
 <li>
 Good knowledge on Formulation and Process characterization studies
 </li>
 <li>
 Experienced in handling instruments like Density meter / Osmometer / Viscometer / Turbidity meter / UV Spectrophotometer / HPLC systems
 </li>
 <li>
 Ability to learn quickly, enthusiastic, sincere, positive attitude, hardworking
 </li>
 <li>
 Should have positive temperament, rational/logical thinking and enthusiasm to deliver on time, hardworking and committed.
 </li>
 <li>
 Basic understanding of statistics, DoE and data visualization
 </li>
 <li>
 Should be experienced/demonstrated formulation and process characterization.
 </li>
 <li>
 Authoring Technical documents like PDR, Tech transfer, study reports etc.
 
 
 </li>
 </ul>
 
 Education
 
 
 
 <ul>
 <li>
 M.Pharm or M.Sc. in Life Science/Biotechnology/ Bioprocess Engineering/ Pharmaceuticals/Biopharmaceuticals/ Biopharmaceutical Technology/ Biochemistry or equivalent degree.
 
 
 </li>
 </ul>
 
 Industry Experience
 
 
 
 <ul>
 <li>
 Minimum 6-9 years of relevant practical experience in formulation development for biopharmaceuticals, specifically with mAbs, Proteins and peptides.
 
 
 </li>
 </ul>
 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.
 
 
 Pls visit us at https://syngeneintl.com/ to know more about us and what we do.
</div>

Formulation 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 biomarker discovery and validation to support clinical trials.
Key responsibilities:<ul><li>
Coordinates and oversees exploratory sample shipment and analysis to guarantee consistency and reliability in results</li><li>
Reviews and verifies exploratory biomarker data to ensure completeness and support data transfer to Study Sponsor.</li><li>
Liaises with specialty laboratories to facilitate communication, address issues, and ensure alignment on study objectives and timelines</li><li>
Critically reviews sample analysis plan</li><li>
Reports and maintains comprehensive documentation of all monitoring activities, including assay performance data and any deviations.</li><li>
Identifies potential risks related to sample analysis and implement mitigation strategies</li><li>
Regularly updates Study Sponsor team members on progress, challenges, and outcomes related to biomarker sample analysis activities.</li><li>
Any other tasks as deem appropriate for the conduct of the exploratory biomarker oversight</li></ul>
Education and Experience:<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><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 working knowledge of several classes of biomarker techniques and analytical platforms (e.g., qPCR, NGS, IHC, FISH, MRI/PET/CT imaging, flow cytometry, LS/MS, ligand binding assays, enzymatic assays, etc.) required</li><li>
Previous experience developing exploratory and/or diagnostic biomarkers assays including study design, method validation, and reporting required</li><li>
Expert knowledge of biomarker analytical data analysis and reporting required</li><li>
Strong working knowledge of GCP/GCLP guidelines and other current global regulations required</li><li>
Strong working knowledge of assay validation requirements for Phase I/II clinical trials required</li><li>
Previous experience characterizing the pharmacological effects using biomarker assays</li><li>
Previous experience defining the context of use (COU) and data analysis strategy for biomarkers</li><li>
Previous experience translating biomarker assay applicability to all clinical trial phases</li><li>
Extensive experience collaborating with independent stakeholders including escalation, risk management, and confidentiality management</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

<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? 
Join our collaborative team at Thermo Fisher Scientific, where you'll contribute to our mission of making the world healthier, cleaner, and safer. As a QC Scientist III, you'll perform sophisticated analytical testing and provide quality oversight for biopharmaceutical products. You'll work with advanced technology and collaborate with cross-functional teams to ensure product safety and compliance with regulatory requirements. This role offers significant opportunities to grow your expertise while supporting the development and manufacturing of life-changing therapeutics. 
 
You'll conduct complex analytical testing, lead method validations, perform data review, and troubleshoot technical issues. Key responsibilities include executing and reviewing tests for product release, stability, and in-process samples; authoring and reviewing technical documentation; participating in investigations; and interfacing with clients and regulatory authorities. Your work will directly impact patient safety and product quality while advancing scientific innovation.
A Day in the Life:<ul><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>
Help develop and build the foundation of a liquid chromatography technical team by implementing standard practices and policies.</li><li>
Perform testing on In-Process, DS release, DS stability, DP Stability, and various other non-routine samples, ensuring timely delivery for projects</li><li>
Recognize and report out-of-specification/ out-of-trend results to laboratory management; recommend solutions</li><li>
Participate in analytical method validation/transfer, method establishment/qualification routine and stability analysis.</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>
Perform all duties in compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines</li><li>
Participating in laboratory activities, including safety inspections and client audits</li><li>
Communicate findings and discuss relevance of your data to a multi-discipline team consisting of upstream and downstream process development scientists, quality control, quality assurance, process engineers and our customers.</li></ul>
Keys to Success:<ul><li>Advanced Degree plus 3 years of experience, or Bachelor's Degree plus 5 years of experience in GMP pharmaceutical/biopharmaceutical quality control</li><li>Preferred Fields of Study: Chemistry, Biology, Biochemistry, or related scientific field</li><li>Expertise in analytical techniques such as HPLC, UPLC, CE-SDS, cIEF/ICE, ELISA, and cell-based assays</li><li>Strong knowledge of FDA, EMA, ICH, and GxP regulations</li><li>Experience with method validation, transfer, and qualification</li><li>Proficiency in data analysis and laboratory information management systems</li><li>Advanced technical writing and documentation skills</li><li>Strong project management and organizational abilities</li><li>Excellent interpersonal and communication skills</li><li>Ability to work independently and lead cross-functional teams</li><li>Experience with quality investigations and CAPAs</li><li>Proficiency with Microsoft Office Suite and relevant analytical software</li><li>Ability to wear PPE and work in laboratory environments</li><li>May require weekend/flexible scheduling based on business needs</li><li>Physical requirements include standing, lifting up to 25 lbs, and manual dexterity</li><li>Strong attention to detail and problem-solving skills</li><li>Experience mentoring team members preferred</li></ul>
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 and 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 III

Cytiva

<div>
 
 Bring more to life.
 
 
 
 Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
 
 
 At Cytiva, one of Danaher&rsquo;s 15+ operating companies, our work saves lives&mdash;and we&rsquo;re all united by a shared commitment to innovate for tangible impact.
 
 
 You&rsquo;ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher&rsquo;s system of continuous improvement, you help turn ideas into impact &ndash; innovating at the speed of life.
 
 
 Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
 
 
 At Cytiva you will be able to continuously improve yourself and us &ndash; working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career.
 
 
 Learn about the Danaher Business System which makes everything possible.
 
 
 The R&amp;D team at Cytiva is responsible for the design, development, test, verification and validation of Cytiva&rsquo;s instruments and technology solutions across the bioprocess continuum.
 
 
 As a
 
 Scientist
 
 with the India R&amp;D team, you will perform hands-on laboratory work to establish the products under development meet intended use. You are also expected to support efforts to analyze and provide innovative solutions to address our customer needs.
 
 
 This role requires strong scientific and technical expertise in upstream technologies, specifically to run cell cultures and operate bioreactors. Knowledge of process development and scaling strategies will be advantageous.
 
 
 This position reports to the
 
 Manager &ndash; Applied Sciences
 
 and is part of the
 
 Central Technology Organization (CTO) R&amp;D department
 
 located in
 
 Bangalore
 
 . It will be an on-site role.
 
 
 
 What Will You Do
 
 
 
 <ul>
 <li>
 Serve as the technical bridge between users and the engineering team helping translate user requirements to system specifications and helping validate that the finished products meet intended-use.
 </li>
 <li>
 Plan, design and execute upstream experiments (cell culture, bioreactor operations), to test technology hypotheses.
 </li>
 <li>
 Undertake experimental optimization of process parameters for robustness and scalability.
 </li>
 <li>
 Analyze data using standard techniques; prepare clear reports to meet requirements of our quality management system
 
 
 </li>
 </ul>
 
 Who You Are
 
 
 
 <ul>
 <li>
 Master&rsquo;s degree in Biotechnology, Biochemical Engineering, or related field.
 </li>
 <li>
 3+ years of hands-on experience in upstream bioprocessing, preferably in a biopharmaceutical manufacturing or life sciences product development environment.
 </li>
 <li>
 Familiarity with cGMP guidelines and laboratory safety practices.
 </li>
 <li>
 Passion for hands-on lab work and upskilling to emergent technologies.
 </li>
 <li>
 Ability to solve straightforward problems independently.
 </li>
 <li>
 Good communication skills and ability to work effectively in a cross-functional team environment.
 
 
 </li>
 </ul>
 Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it&rsquo;s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
 
 
 Join our winning team today. Together, we&rsquo;ll accelerate the real-life impact of tomorrow&rsquo;s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
 
 
 For more information, visit www.danaher.com.
</div>

Scientist - Upstream Technologies

<div>Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Cytiva, one of Danaher&rsquo;s 15+ operating companies, our work saves lives&mdash;and we&rsquo;re all united by a shared commitment to innovate for tangible impact.
You&rsquo;ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher&rsquo;s system of continuous improvement, you help turn ideas into impact &ndash; innovating at the speed of life.
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us &ndash; working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career.
Learn about the Danaher Business System which makes everything possible.
The R&amp;D team at Cytiva is responsible for the design, development, test, verification and validation of Cytiva&rsquo;s instruments and technology solutions across the bioprocess continuum.
As a Scientist with the India R&amp;D team, you will perform hands-on laboratory work to establish the products under development meet intended use. You are also expected to support efforts to analyze and provide innovative solutions to address our customer needs.
This role requires strong scientific and technical expertise in upstream technologies, specifically to run cell cultures and operate bioreactors. Knowledge of process development and scaling strategies will be advantageous.
 This position reports to the Manager &ndash; Applied Sciences and is part of the Central Technology Organization (CTO) R&amp;D department located in Bangalore. It will be an on-site role.
What will you do:<ul><li>
Serve as the technical bridge between users and the engineering team helping translate user requirements to system specifications and helping validate that the finished products meet intended-use.</li><li>
Plan, design and execute upstream experiments (cell culture, bioreactor operations), to test technology hypotheses.</li><li>
Undertake experimental optimization of process parameters for robustness and scalability.</li><li>
Analyze data using standard techniques; prepare clear reports to meet requirements of our quality management system</li></ul>
Who you are:<ul><li>
Master&rsquo;s degree in Biotechnology, Biochemical Engineering, or related field.</li><li>
3+ years of hands-on experience in upstream bioprocessing, preferably in a biopharmaceutical manufacturing or life sciences product development environment.</li><li>
Familiarity with cGMP guidelines and laboratory safety practices.</li><li>
Passion for hands-on lab work and upskilling to emergent technologies.</li><li>
Ability to solve straightforward problems independently.</li><li>
Good communication skills and ability to work effectively in a cross-functional team environment.</li></ul>
Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it&rsquo;s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
Join our winning team today. Together, we&rsquo;ll accelerate the real-life impact of tomorrow&rsquo;s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.</div>

<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

<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

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