Research Associate, Injectable Formulation Development Job at Proclinical (Lexington)

Research Associate I - R&D, Complex Product Development

This is where new knowledge is discovered. Baxter's Research and Development tea...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Master in Pharmacy or equivalent discipline with 6 to 10 years of experience
PhD in biophysics, biochemistry or equivalent discipline with 0 to 5 years of experience with spectroscopic and biophysical methods, including CD, FTIR, fluorescence spectroscopy
Competency in the acquisition, processing and data analysis by CD, FTIR, and fluorescence spectroscopy for analysis of proteins and peptides for regulatory submissions
Basic understanding of working principles of liquid chromatographic methods, dynamic light scattering, AF4-MALS, SV-AUC, & related orthogonal methods to assess protein higher order structures
Proficiency in literature search through publication and patent databases, repositories (e.g. Pubmed), scientific webinars by regulatory agencies
Knowledge of pharmacopoeia, ICH Guidelines and means to implement them for product development
Experience in the operation, calibration and preventive maintenance of NMR and other instruments
Trouble shooting of various problems obtain during the product development
Knowledge of good laboratory practices and good documentation practices
Communication skills

Job Responsibility

To perform advanced characterization of complex injectable drugs, including proteins & peptides, oligonucleotides, iron formulations, carbohydrates & other biomolecular APIs and various impurities in lyophilized, liquid, emulsions & other formulations for regulatory submission following GLP norms
To manage outsourced studies at CROs, academic institutes & other external facilities, from study design, execution, analysis and report preparation
To demonstrate subject matter expertise and help overcome technical challenges in product development, by liaising with formulation and other cross-functional teams as a Subject Matter Expertise (SME)
To understand the project with guidance of Sub-department Manager and follow their instructions
To provide necessary assistance for various procurement activities, review quotations, engage suppliers to procure required goods & services in a timebound manner
To complete the planned work in the stipulated time frame, inform the Sub-department Manager if any deviation or issues are observed
To keep track of each activity related to product analysis and development activities
To carry out all the testing and data recording according to the approved SOPs/ ALCOA++ principle and current pharmacopoeia
To verify the shelf life of the chemical or reagent before performing analysis of the material or product
To follow Good Documentation Practices & Good Laboratory Practices, maintain lab notebooks & other records appropriately

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Research Associate I, R&D Complex Product Development

This is where new knowledge is discovered. Baxter's Research and Development tea...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Masters (Pharmacy, or equivalent discipline) with 6 to 10 years of experience, or, PhD (biophysics, biochemistry or equivalent discipline) with 0 to 5 years of experience in SEC-UV-MALS and related methods encompassing liquid chromatography, light scattering, diffraction and light obscuration
Competency in the acquisition, processing and data analysis by SEC-UV-MALS and light scattering/diffraction/obscuration techniques for analysis of peptides and iron colloidal products for regulatory submissions is mandatory
Expertise in computational chemistry, molecular modeling and statistical methods are beneficial attributes
Basic understanding of working principles of biophysical & spectroscopic methods, like CD, FTIR, UV, EPR, Mossbauer, and fluorescence spectroscopy, particle XRD, microscopy methods (AFM & EM) & related orthogonal methods to assess structural properties of proteins and iron colloids
Proficiency in literature search through publication and patent databases, repositories (e.g. Pubmed), scientific webinars by regulatory agencies, etc, to remain updated on advanced characterization methods and recent scientific developments
Knowledge of pharmacopoeia, ICH Guidelines and means to implement them for product development
Experience in the operation, calibration and preventive maintenance of NMR and other instruments to ensure continued usage
Trouble shooting of various problems obtain during the product development
Knowledge of good laboratory practices and good documentation practices
Communication skills

Job Responsibility

Perform advanced characterization of complex injectable drugs, including iron formulations, proteins & peptides, oligonucleotides, carbohydrates & other biomolecular APIs and various impurities for regulatory submission following GLP norms
Manage outsourced studies at CROs, academic institutes & other external facilities, from study design, execution, analysis and report preparation
Travel to external facilities
Demonstrate subject matter expertise and help overcome technical challenges in product development, by liaising with formulation and other cross-functional teams
Understand the project with guidance of Sub-department Manager and follow their instructions
Provide necessary assistance for various procurement activities, review quotations, engage suppliers to procure required goods & services
Complete the planned work in the stipulated time frame
Keep track of each activity related to product analysis and development activities
Carry out all the testing and data recording according to the approved SOPs/ ALCOA++ principle and current pharmacopoeia
Verify the shelf life of the chemical or reagent before performing analysis

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Research Associate I - R&D, Complex Product Development

This is where new knowledge is discovered. Baxter's Research and Development tea...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Masters (Pharmacy, or equivalent discipline) with 6 to 10 years of experience, or, PhD (biophysics, biochemistry or equivalent discipline) with 0 to 5 years of experience with spectroscopic and biophysical methods, including CD, FTIR, fluorescence spectroscopy
Competency in the acquisition, processing and data analysis by CD, FTIR, and fluorescence spectroscopy for analysis of proteins and peptides for regulatory submissions is mandatory
Expertise in computational chemistry, molecular modeling and statistical methods are beneficial attributes
Basic understanding of working principles of liquid chromatographic methods, dynamic light scattering, AF4-MALS, SV-AUC, & related orthogonal methods to assess protein higher order structures
Proficiency in literature search through publication and patent databases, repositories (e.g. Pubmed), scientific webinars by regulatory agencies, etc, to remain updated on advanced characterization methods and recent scientific developments
Knowledge of pharmacopoeia, ICH Guidelines and means to implement them for product development
Experience in the operation, calibration and preventive maintenance of NMR and other instruments to ensure continued usage
Trouble shooting of various problems obtain during the product development
Knowledge of good laboratory practices and good documentation practices
Communication skills

Job Responsibility

To perform advanced characterization of complex injectable drugs, including proteins & peptides, oligonucleotides, iron formulations, carbohydrates & other biomolecular APIs and various impurities in lyophilized, liquid, emulsions & other formulations for regulatory submission following GLP norms
To manage outsourced studies at CROs, academic institutes & other external facilities, from study design, execution, analysis and report preparation
Traveling to external facilities, as and when required, is a mandatory requirement for this position
To demonstrate subject matter expertise and help overcome technical challenges in product development, by liaising with formulation and other cross-functional teams as a Subject Matter Expertise (SME)
To understand the project with guidance of Sub-department Manager and follow their instructions
To provide necessary assistance for various procurement activities, review quotations, engage suppliers to procure required goods & services in a timebound manner
To complete the planned work in the stipulated time frame, inform the Sub-department Manager if any deviation or issues are observed
To keep track of each activity related to product analysis and development activities
To carry out all the testing and data recording according to the approved SOPs/ ALCOA++ principle and current pharmacopoeia
Data recording in ELN and sign off must be completed on time

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Research Associate I - R&D, Complex Product Development

This is where new knowledge is discovered. Baxter's Research and Development tea...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Masters (Pharmacy, or equivalent discipline) with 6 to 10 years of experience, or, PhD (biophysics, biochemistry or equivalent discipline) with 0 to 5 years of experience with spectroscopic and biophysical methods, including CD, FTIR, fluorescence spectroscopy
Competency in the acquisition, processing and data analysis by CD, FTIR, and fluorescence spectroscopy for analysis of proteins and peptides for regulatory submissions is mandatory
Expertise in computational chemistry, molecular modeling and statistical methods are beneficial attributes
Basic understanding of working principles of liquid chromatographic methods, dynamic light scattering, AF4-MALS, SV-AUC, & related orthogonal methods to assess protein higher order structures
Proficiency in literature search through publication and patent databases, repositories (e.g. Pubmed), scientific webinars by regulatory agencies, etc, to remain updated on advanced characterization methods and recent scientific developments
Knowledge of pharmacopoeia, ICH Guidelines and means to implement them for product development
Experience in the operation, calibration and preventive maintenance of NMR and other instruments to ensure continued usage
Trouble shooting of various problems obtain during the product development
Knowledge of good laboratory practices and good documentation practices
Communication skills

Job Responsibility

To perform advanced characterization of complex injectable drugs, including proteins & peptides, oligonucleotides, iron formulations, carbohydrates & other biomolecular APIs and various impurities in lyophilized, liquid, emulsions & other formulations for regulatory submission following GLP norms
To manage outsourced studies at CROs, academic institutes & other external facilities, from study design, execution, analysis and report preparation
To demonstrate subject matter expertise and help overcome technical challenges in product development, by liaising with formulation and other cross-functional teams as a Subject Matter Expertise (SME)
To understand the project with guidance of Sub-department Manager and follow their instructions
To provide necessary assistance for various procurement activities, review quotations, engage suppliers to procure required goods & services in a timebound manner
To complete the planned work in the stipulated time frame, inform the Sub-department Manager if any deviation or issues are observed
To keep track of each activity related to product analysis and development activities
To carry out all the testing and data recording according to the approved SOPs/ ALCOA++ principle and current pharmacopoeia
To verify the shelf life of the chemical or reagent before performing analysis of the material or product
To follow Good Documentation Practices & Good Laboratory Practices, maintain lab notebooks & other records appropriately

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Research Associate I, R&D Complex Product Development

This is where new knowledge is discovered. Baxter's Research and Development tea...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Masters (Pharmacy, or equivalent discipline) with 6 to 10 years of experience, or, PhD (biophysics, biochemistry or equivalent discipline) with 0 to 5 years of experience in SEC-UV-MALS and related methods encompassing liquid chromatography, light scattering, diffraction and light obscuration
Competency in the acquisition, processing and data analysis by SEC-UV-MALS and light scattering/diffraction/obscuration techniques for analysis of peptides and iron colloidal products for regulatory submissions is mandatory
Expertise in computational chemistry, molecular modeling and statistical methods are beneficial attributes
Basic understanding of working principles of biophysical & spectroscopic methods, like CD, FTIR, UV, EPR, Mossbauer, and fluorescence spectroscopy, particle XRD, microscopy methods (AFM & EM) & related orthogonal methods to assess structural properties of proteins and iron colloids
Proficiency in literature search through publication and patent databases, repositories (e.g. Pubmed), scientific webinars by regulatory agencies, etc, to remain updated on advanced characterization methods and recent scientific developments
Knowledge of pharmacopoeia, ICH Guidelines and means to implement them for product development
Experience in the operation, calibration and preventive maintenance of NMR and other instruments to ensure continued usage
Trouble shooting of various problems obtain during the product development
Knowledge of good laboratory practices and good documentation practices
Communication skills

Job Responsibility

To perform advanced characterization of complex injectable drugs, including iron formulations, proteins & peptides, oligonucleotides, carbohydrates & other biomolecular APIs and various impurities in lyophilized, liquid, emulsions & other formulations for regulatory submission following GLP norms
To manage outsourced studies at CROs, academic institutes & other external facilities, from study design, execution, analysis and report preparation
To demonstrate subject matter expertise and help overcome technical challenges in product development, by liaising with formulation and other cross-functional teams as a Subject Matter Expertise (SME)
To understand the project with guidance of Sub-department Manager and follow their instructions
To provide necessary assistance for various procurement activities, review quotations, engage suppliers to procure required goods & services in a timebound manner
To complete the planned work in the stipulated time frame, inform the Sub-department Manager if any deviation or issues are observed
To keep track of each activity related to product analysis and development activities
To carry out all the testing and data recording according to the approved SOPs/ ALCOA++ principle and current pharmacopoeia
To verify the shelf life of the chemical or reagent before performing analysis of the material or product
To follow Good Documentation Practices & Good Laboratory Practices, maintain lab notebooks & other records appropriately

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Associate III Design Quality

This is where you make a difference in our patients’ safety. As a member of the ...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Having a good knowledge of injectable formulation - peptide/liposomes and complex generic molecules
Having a good knowledge of product development and life cycle management
Having a good knowledge of critical analytical techniques like LCMS, GCMS, HPLC, GC, IC etc
Having a good knowledge of regulatory requirements for ANDA/NDA submissions
Having good experience of responding regulatory queries
Having good critical thinking ability to challenge and resolve the technical concerns related to submission studies

Job Responsibility

To participate in meetings with cross functional teams like Analytical, Regulatory, Quality, manufacturing, Contract Manufacturing Organization (CMO), Project management, Characterization team for on time review support
To participate in meetings with Contract Manufacturing Organizations (CMOs) & Contract Research Organizations (CROs) & contract Labs for on-time review support
Responsible for tech transfer meetings with External Site as a core team member from quality for analytical discussion
To review, approve and ensure Technology Transfer/Validation/Verification/Post- production studies documents to respective plants
To be a part of investigations and to perform investigations extensively to derive root cause and its corrective measures and preventive actions
Quality SME for risk analysis of GPRD studies
To review and approve change controls, NCR/SNCR, CAPA, Effectiveness checks, etc
To carry out internal quality audits and perform GEMBA walks of R&D labs for compliance & betterment as per current regulations and GLP (Good Laboratory Practice)
To impart training to R&D team members on various aspects of GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) guidelines and practices
To ensure that the development is carried out as per the latest QBD (Quality by Design) and PDLM concepts

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Associate III, Design Quality

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Having a good knowledge of injectable formulation - peptide/liposomes and complex generic molecules
Having a good knowledge of product development and life cycle management
Having a good knowledge of critical analytical techniques like LCMS, GCMS, HPLC, GC, IC etc
Having a good knowledge of regulatory requirements for ANDA/NDA submissions
Having good experience of responding regulatory queries
Having good critical thinking ability to challenge and resolve the technical concerns related to submission studies
To participate in meetings with cross functional teams like Analytical, Regulatory, Quality, manufacturing, Contract Manufacturing Organization (CMO), Project management, Characterization team for on time review support
To participate in meetings with Contract Manufacturing Organizations (CMOs) & Contract Research Organizations (CROs) & contract Labs for on-time review support
Responsible for tech transfer meetings with External Site as a core team member from quality for analytical discussion
To review, approve and ensure Technology Transfer/Validation/Verification/Post- production studies documents to respective plants

Job Responsibility

To participate in meetings with cross functional teams like Analytical, Regulatory, Quality, manufacturing, Contract Manufacturing Organization (CMO), Project management, Characterization team for on time review support
To participate in meetings with Contract Manufacturing Organizations (CMOs) & Contract Research Organizations (CROs) & contract Labs for on-time review support
Responsible for tech transfer meetings with External Site as a core team member from quality for analytical discussion
To review, approve and ensure Technology Transfer/Validation/Verification/Post- production studies documents to respective plants
To be a part of investigations and to perform investigations extensively to derive root cause and its corrective measures and preventive actions
Quality SME for risk analysis of GPRD studies
To review and approve change controls, NCR/SNCR, CAPA, Effectiveness checks, etc
To carry out internal quality audits and perform GEMBA walks of R&D labs for compliance & betterment as per current regulations and GLP (Good Laboratory Practice)
To impart training to R&D team members on various aspects of GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) guidelines and practices
To ensure that the development is carried out as per the latest QBD (Quality by Design) and PDLM concepts

What we offer

Support for parents
Continuing education / Professional development
Employee health and wellness benefits
Paid time off
2 days per year for volunteering

Fulltime

Associate III, Design Quality

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Having a good knowledge of injectable formulation - peptide/liposomes and complex generic molecules
Having a good knowledge of product development and life cycle management
Having a good knowledge of critical analytical techniques like LCMS, GCMS, HPLC, GC, IC etc
Having a good knowledge of regulatory requirements for ANDA/NDA submissions
Having good experience of responding regulatory queries
Having good critical thinking ability to challenge and resolve the technical concerns related to submission studies

Job Responsibility

To participate in meetings with cross functional teams like Analytical, Regulatory, Quality, manufacturing, Contract Manufacturing Organization (CMO), Project management, Characterization team for on time review support
To participate in meetings with Contract Manufacturing Organizations (CMOs) & Contract Research Organizations (CROs) & contract Labs for on-time review support
Responsible for tech transfer meetings with External Site as a core team member from quality for analytical discussion
To review, approve and ensure Technology Transfer/Validation/Verification/Post- production studies documents to respective plants
To be a part of investigations and to perform investigations extensively to derive root cause and its corrective measures and preventive actions
Quality SME for risk analysis of GPRD studies
To review and approve change controls, NCR/SNCR, CAPA, Effectiveness checks, etc
To carry out internal quality audits and perform GEMBA walks of R&D labs for compliance & betterment as per current regulations and GLP (Good Laboratory Practice)
To impart training to R&D team members on various aspects of GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) guidelines and practices
To ensure that the development is carried out as per the latest QBD (Quality by Design) and PDLM concepts

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

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Research Associate, Injectable Formulation Development

Job Description

Job Responsibility

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