Senior Scientist - HPLC , UPLC , KF and GMP
Job DescriptionThermo 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 - to enable our clients to make the world healthier, safer, and cleaner.
Within our Analytical Services team, we have a functional service provider solution, which is an outstanding partnership that allows our customers to use 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.
In this position you will develop, validate, and implement analytical methods to assess physical and chemical properties of pharmaceutical materials.
This work is conducted in a highly collaborative, multi-disciplinary team charged with the overall research & development of our active ingredients, formulated products, and the associated manufacturing processes.
You will play an important but supporting role throughout the development of new drug candidates from discovery to commercialization, contributing to the advancement of newtherapeutics.
Duties and responsibilities Contributes to the development of priority drug candidates through the development, validation, and implementation of analytical methods involving modern analytical instrumentation including HPLC/UPLC, GC, dissolution, FT-IR, Karl Fischer titrations, etc.
Transfers validated methods to customer labs, including Client and partner-owned quality control (QC) labs.
Performs testing for development and clinical materials and stability samples in accordance with established methods, specifications and protocols under supervision.
Knows the fundamentals of analytical methodology and can troubleshoot instrumentation and method performance issues of routine complexity.
Documents / reviews laboratory work using laboratory notebooks / worksheets that is detailed, timely and in compliance with GLP / GMP requirements.
Contributes data to the preparation of high-quality technical reports as source documents for regulatory submissions.
Reviews data for compliance and adherence to specifications and acceptance criteria.
Communicates results according to project timelines and works with collaborators to understand project needs and contribute to overall analytical control strategy.
Draws basic conclusions from data and results.
Complies with Environmental Health and Safety Requirements Other duties as assigned by supervisor.
Our 4i Values:
Integrity - Innovation - Intensity - InvolvementIf you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, submit your application - we'd love to hear from you!Education and
Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4
years).
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:
Solid understanding and knowledge of general chemistry and separation science At least 2 years of experience in a regulated GMP lab.
Hands-on experience with separations techniques (HPLC, UPLC, GC, etc.
) Familiar with HPLC, dissolution, FT-IR, UV/VIS spectrophotometry, titrations, etc.
Experience in laboratory investigation and documentation of Out-of-Specification results.
Experience in the development and performance of analytical tests for a variety of drug substances and products (including solid oral dosage forms and injectables) is a plus.
Familiar writing technical reports Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance Ability to utilize Microsoft Excel and Word to perform tasks Proficiency on technical operating systems Proven problem solving and troubleshooting abilities Effective oral and written communication skills Proven ability in technical writing skills Time management and project management skills Ability to work in a collaborative work environment with a team Proven problem solving and troubleshooting abilities Ability to train junior staff Working Environment:
Thermo Fisher 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:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary and/or standing for typical working hours.
Able to lift and move objects up to 25 pounds Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with proficiency.
May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.
Recommended Skills Audio Equipments Chromatography Clinical Works Communication General Chemistry Ich Guidelines Estimated Salary: $20 to $28 per hour based on qualifications.
We are passionate, deliberate, and driven by our mission - to enable our clients to make the world healthier, safer, and cleaner.
Within our Analytical Services team, we have a functional service provider solution, which is an outstanding partnership that allows our customers to use 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.
In this position you will develop, validate, and implement analytical methods to assess physical and chemical properties of pharmaceutical materials.
This work is conducted in a highly collaborative, multi-disciplinary team charged with the overall research & development of our active ingredients, formulated products, and the associated manufacturing processes.
You will play an important but supporting role throughout the development of new drug candidates from discovery to commercialization, contributing to the advancement of newtherapeutics.
Duties and responsibilities Contributes to the development of priority drug candidates through the development, validation, and implementation of analytical methods involving modern analytical instrumentation including HPLC/UPLC, GC, dissolution, FT-IR, Karl Fischer titrations, etc.
Transfers validated methods to customer labs, including Client and partner-owned quality control (QC) labs.
Performs testing for development and clinical materials and stability samples in accordance with established methods, specifications and protocols under supervision.
Knows the fundamentals of analytical methodology and can troubleshoot instrumentation and method performance issues of routine complexity.
Documents / reviews laboratory work using laboratory notebooks / worksheets that is detailed, timely and in compliance with GLP / GMP requirements.
Contributes data to the preparation of high-quality technical reports as source documents for regulatory submissions.
Reviews data for compliance and adherence to specifications and acceptance criteria.
Communicates results according to project timelines and works with collaborators to understand project needs and contribute to overall analytical control strategy.
Draws basic conclusions from data and results.
Complies with Environmental Health and Safety Requirements Other duties as assigned by supervisor.
Our 4i Values:
Integrity - Innovation - Intensity - InvolvementIf you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, submit your application - we'd love to hear from you!Education and
Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4
years).
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:
Solid understanding and knowledge of general chemistry and separation science At least 2 years of experience in a regulated GMP lab.
Hands-on experience with separations techniques (HPLC, UPLC, GC, etc.
) Familiar with HPLC, dissolution, FT-IR, UV/VIS spectrophotometry, titrations, etc.
Experience in laboratory investigation and documentation of Out-of-Specification results.
Experience in the development and performance of analytical tests for a variety of drug substances and products (including solid oral dosage forms and injectables) is a plus.
Familiar writing technical reports Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance Ability to utilize Microsoft Excel and Word to perform tasks Proficiency on technical operating systems Proven problem solving and troubleshooting abilities Effective oral and written communication skills Proven ability in technical writing skills Time management and project management skills Ability to work in a collaborative work environment with a team Proven problem solving and troubleshooting abilities Ability to train junior staff Working Environment:
Thermo Fisher 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:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary and/or standing for typical working hours.
Able to lift and move objects up to 25 pounds Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with proficiency.
May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.
Recommended Skills Audio Equipments Chromatography Clinical Works Communication General Chemistry Ich Guidelines Estimated Salary: $20 to $28 per hour based on qualifications.
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