Associate Product Quality - Data Verification Job at Amgen (Hyderabad)

Associate Director, Product Quality Assurance

The Associate Director of Product Quality for Cell and Gene Therapy Programs wil...

Location

United States , Cambridge

Salary:

185000.00 - 225000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelors or Advanced degree in scientific discipline
12+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality with at least 4 years of which should have been in a CMC-focused position in Cell and Gene Therapy Quality role
Detailed knowledge and understanding of GMP regulations and Food and Drug Administration (FDA) requirements
Ability to influence without direct authority
Ability to develop into a primary PQL for Beam programs
Excellent verbal and written communication skills, detail-oriented personality and ability to work and drive change across functions
Experience interacting with regulatory health authorities at pre- and post-approval inspection
Strong team player that has a customer service approach and is solution oriented
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
Excellent listening, communication and interpersonal skills fostering team spirit

Job Responsibility

Provides strategic Quality CMC-focused support based on Program Team timelines, milestones, and regulatory commitments
Drives and takes action on Phase Appropriate Quality strategy for Beam’s products
Performs Quality review/approval of records and documentation related to manufacturing such as process defining documentation
Performs product quality impact assessments for product complaints, manufacturing deviations, OOT/OOS results, MRB, adverse trends, etc
Quality reviewer and approver of select technical documents (e.g. complaints, temperature excursion reports, justification of specification (JoS), specifications, method validations, critical quality attribute (CQA) assessment, comparability, risk assessments, continued process verification (CPV), tech transfer, ad hoc testing / characterization protocols, etc.)
Ad hoc Quality representative on Program Team and CMC Team in support of primary PQL
Ensures alignment with regulatory requirements, industry standards / best practices, and Beam initiatives
Support clinical to commercial analytical control strategy
Strategic and technical support across product lifecycle (manufacturing process and analytical method changes, tech transfer, characterization, comparability, validations, technology improvements, etc.)
Reviews manufacturing process performance, analytical method performance, stability data, etc. for signals / trends / patterns to proactively monitor and if necessary, support mitigations

Fulltime

Associate Quality Control (Analytical)

Amgen is one of the world's leading independent biotechnology companies. For ove...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Chemistry, Biochemistry, Life Science or related technological field and 2 years of directly related experience OR Associate's Degree in Chemistry, Biochemistry, Life Science or related technological field and 4 years of directly related experience OR High School Diploma in Chemistry, Biochemistry, Life Science or related technological field / GED and 6 years of directly related experience
1-2 years of relevant laboratory experience in the commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry and analytical testing experience preferred
Knowledge and understanding of GMP pharmaceutical production, pharmaceutical plant operation and associated testing methods
Experience with Quality Control testing and laboratory operations for common testing methods and equipment (e.g. including but not limited to UPLC, HPLC, LC-MS, GC-HS, LOD, Auto-titration, KF, Optical Rotation, wet chemistry, FT-IR, pH, conductivity, TOC, Potency, ELISA, Capillary Electrophoresis, DNA Testing)
Good communication skills (technical writing and verbal communication/ presentation)
Interact effectively with variety of communication and working styles and ability to work well in teams
Ability to manage multiple simultaneous activities in a rapidly changing environment
Problem solving skills and troubleshooting skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality.

Job Responsibility

Perform analytical testing of in-process control, drug substance intermediate, final release, stability and plant cleaning samples in a GMP pharmaceutical environment
Support laboratory operations including but not limited to equipment qualification, calibration, cleaning and maintenance, reagent/ buffer preparation
Responsible for maintenance of chemicals and consumables inventory
Ensure proper handling, storage, disposal of all chemicals used in the lab
Responsible for laboratory housekeeping and document archival duties
Participate in laboratory investigations and assist in timely closure of investigations, CAPAs and deviations
Participate in method verification and method validation/ transfer for new product introduction (when required)
Perform review of laboratory data/ records
Assist in SOP/ protocol/ report writing
Assist in periodic review of laboratory procedures and risk assessment

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Senior Associate Quality Control I (Chemistry)

Amgen is one of the world’s leading independent biotechnology companies. For ove...

Location

Singapore , Tuas

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree in Chemistry, Biochemistry or related technological field
Bachelor’s degree in Chemistry, Biochemistry or related technological field and 2 years of directly related experience
Associate’s degree in Chemistry, Biochemistry or related technological field and/or 4 years of directly related experience
High school diploma in Chemistry, Biochemistry or related technological field / GED and 6 years of directly related experience
Preferred 4 years of relevant professional work experience within the pharmaceutical or biopharmaceutical industry and laboratory testing experience preferred
Strong knowledge and understanding of GMP pharmaceutical production, pharmaceutical plant operation and associated testing methods
Strong technical knowledge in and experience with the following QC Chemistry/ Biochemistry/ Raw material testing methods and equipment is required: Immunosorbent Assay/Cell based Bioassay: Potency, Host Cell Proteins, ELISA
Chromatography: UPLC, HPLC, LC-MS, GC-HS
General Chemistry: Capillary Electrophosis, LOD, Autotitration, KF, Optical Rotation, FT-IR, Conductivity, TOC, pH, wet chemistry
Ability to preempt issues and disruptions to lab operations and develop mitigation actions

Job Responsibility

Plan, schedule, perform analytical testing and approval of test results on raw materials, water, in-process control, drug substance and stability samples in GMP pharmaceutical environment
Troubleshooting issues related to analytical testing, techniques and equipment
Conduct laboratory investigations and assist in timely closure of investigations, CAPAs and deviations
Support method verification and method validation/transfer for new product introduction (when required)
Train new/ junior laboratory staff and ensure all staff are appropriately trained and qualified to execute the duties assigned to them with respect to the job
Support laboratory operations including but not limited to equipment qualification, calibration and maintenance, reagent/buffer preparation, chemicals/consumables inventory, laboratory housekeeping and document archival duties
Perform periodic review of laboratory procedures and risk assessment
Author of SOPs/protocols/reports
Support regulatory inspections
Participate in continuous improvement initiatives and projects

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Associate I, Quality Assurance

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

To take instructions from Supervisor and shift lead to perform the shift activity
To verify the correct raw material, primary packaging material, and Quantities are issued and dispensed as per the approved Batch records
To perform the line clearance activity at various stages of manufacturing and packaging activity as defined in the BMR
To perform routine In process checks, sampling, periodic verification, online documentation as defined in batch records and escalate any nonconformances
To collect In-process samples, finished product samples, and other samples timely submission into QC/micro
To review and verification of electronic records/Audit trails and printout of the equipment’s like autoclave, sterilizer, filter integrity machine
To ensure the respective documents to be destructed as per approved procedure
To ensure the compliance and GDP of logbooks, online documents, records, and other supporting documents related to products manufactured in the plant and data integrity is ensured
To ensure & provide support to Shift Lead or Supervisor in investigation, in case of any product complaints or non-conformities or Out of Specification
To execute the approved Corrective and Preventive Action (CAPA) with in define timeline

Job Responsibility

This is where you make a difference in our patients’ safety
As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives
Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization

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

Transaction Processor Associate II - Customer Support & Data Processing

We are seeking a detail-driven Transaction Processor Associate II to support a h...

Location

United States , East Hartford

Salary:

20.69 USD / Hour

MMC Group LP

Expiration Date

Until further notice

Requirements

Associate's degree or higher from an accredited institution
Minimum of 6 months experience in a call center or client-facing support role
Experience processing transactions, eligibility verification, or similar administrative functions
Typing speed of at least 40 WPM with high accuracy
Strong attention to detail and ability to identify and correct errors
Ability to manage workload, prioritize tasks, and meet deadlines in a fast-paced environment
Comfortable working with multiple systems and applications simultaneously
Strong analytical and problem-solving skills
Ability to work independently with minimal supervision after training
Excellent verbal, written, and interpersonal communication skills

Job Responsibility

Process and submit denial letters accurately, following strict procedural guidelines
Perform data entry and screen consumer applications within third-party systems
Communicate with clients and stakeholders via phone and written correspondence
Support inbound customer inquiries as needed, serving as a point of contact for program-related questions
Accurately document all consumer interactions and case updates
Maintain a strong understanding of program policies, procedures, and systems
Meet or exceed daily productivity and quality standards, including adherence to Quality Assurance Plan (QAP)
Ensure timely completion of tasks in alignment with contract and service level requirements
Identify, document, and resolve discrepancies or data quality issues
Navigate multiple systems to research and resolve inquiries efficiently

What we offer

Medical, dental, and vision coverage
Life and disability insurance
Additional voluntary benefits

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

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

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. 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
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

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Associate Product Quality - Data Verification

Job Description

Job Responsibility

Requirements

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