CrawlJobs Logo

GMP Manufacturing Analyst – Biologics

mantellassociates.com Logo

Mantell Associates

Location Icon

Location:
Argentina , Buenos Aires

Category Icon
Category:

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided

Job Description:

This is a technically demanding role that requires genuine hands-on manufacturing experience. Our client is looking for someone who has worked directly within large-scale biological production and can apply that deep process understanding to the critical technical review of batch records and manufacturing documentation – this is not a purely administrative function. As GMP Manufacturing Analyst, you will be responsible for the technical review of batch records and process documentation across large-scale biological manufacturing operations. Your first-hand knowledge of upstream and downstream bioprocessing will be essential in identifying discrepancies, ensuring GMP compliance and maintaining the integrity of the manufacturing record. You will be joining a world-class biologics organisation at the forefront of biosimilar development, playing a direct role in ensuring the quality and compliance of medicines reaching patients across Latin America, Europe and beyond. This is a high-impact position for a manufacturing professional who wants to apply their production expertise in a meaningful and technically challenging capacity.

Job Responsibility:

  • Technical review of GMP batch records across large-scale biological manufacturing, covering upstream (cell culture, bioreactor operations) and downstream (purification, chromatography, filtration, formulation) processes
  • Identification, documentation and escalation of batch record discrepancies, incomplete entries and deviations, informed by a genuine understanding of the production process
  • Ensuring all manufacturing documentation meets GMP requirements, internal quality standards and regulatory expectations
  • Collaborating with manufacturing, QA and process development teams to resolve documentation issues efficiently
  • Contributing to the continuous improvement of batch record templates, documentation workflows and best practices

Requirements:

  • Direct, hands-on experience working in large-scale biological manufacturing – floor-level production experience is essential
  • Strong technical knowledge of upstream and/or downstream bioprocessing at scale (500L bioreactor capacity or above)
  • Proven experience in the technical review of GMP batch records or manufacturing process documentation
  • Solid understanding of deviation management and discrepancy investigation processes
  • Experience within monoclonal antibody or biosimilar manufacturing highly desirable
  • Working knowledge of GMP principles and relevant regulatory frameworks (FDA, EMA, ANMAT or equivalent)
  • Ability to review documentation with a critical, process-informed eye – not simply a compliance checklist approach
  • Fluency in Spanish
  • working knowledge of English advantageous
  • Based in Buenos Aires with full-time on-site availability and able to work on a consultancy basis

Nice to have:

  • Experience within monoclonal antibody or biosimilar manufacturing
  • working knowledge of English

Additional Information:

Job Posted:
March 21, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:
PREMIUM
More languages and countries
+ Unlock 31694 hidden job offers
Languages
English Čeština Deutsch Ελληνικά Español Français +15
Countries
United States United Kingdom India Canada Australia +
See plans
Plans from $2.99 / month

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for GMP Manufacturing Analyst – Biologics

GMP Documentation Analyst

This is an excellent opportunity to join a globally recognized biosimilars CDMO ...
Location
Location
Argentina , Buenos Aires
Salary
Salary:
Not provided
mantellassociates.com Logo
Mantell Associates
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Proven experience in GMP documentation support within a pharmaceutical, biologics, or biotechnology manufacturing environment
  • Familiarity with Quality systems such as TrackWise or equivalent electronic Quality Management Systems (eQMS)
  • Strong understanding of regulatory requirements and GMP compliance standards
  • High level of attention to detail with the ability to manage multiple documentation tasks simultaneously
  • Strong organizational and communication skills with a proactive approach to problem solving
  • Availability to work on-site in Buenos Aires, 5 days per week
Job Responsibility
Job Responsibility
  • Review, modify, and manage GMP documentation, including SOPs, Batch Records, QC data, and regulatory documentation
  • Support Quality Assurance activities, including Change Controls, CAPAs, and Quality Event management
  • Assist with report generation and documentation related to product releases and compliance audits
  • Ensure all documentation is complete, accurate, and compliant with internal procedures and current cGMP requirements
  • Maintain document control systems and ensure proper version control and archival processes
  • Support preparation for internal and external audits and regulatory inspections by ensuring documentation readiness and compliance
  • Collaborate cross-functionally with Manufacturing, QC, and QA teams to ensure alignment on documentation standards and timelines
Read More
Arrow Right

Qc Analyst Ii, Microbiology

We are looking for an enthusiastic Microbiology Analyst to support the cGMP Qual...
Location
Location
Canada , Vancouver
Salary
Salary:
78200.00 - 92000.00 CAD / Year
abcellera.com Logo
AbCellera Biologics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 5+ years of QC experience in addition to a Bachelor’s degree
  • Master’s degree in a relevant scientific discipline and 3+ years of QC experience
  • Strong knowledge and experience in Good Manufacturing Practices (GMPs), QC microbiological testing and method qualification requirements
  • Experience with using Milliflex Oasis, Charles River Endosafe nexgen-MCS, LIMS, as well as basic benchtop techniques such as Gram staining, plate reading, vacuum filtration and LAL gel-clot
  • Excellent interpersonal skills, ability to work independently and in a team environment, detail oriented, organized and methodical in execution of tasks
  • Ability to problem solve with sound analytical thinking
Job Responsibility
Job Responsibility
  • Providing microbial support for aseptic product manufacturing in a cGMP regulated environment
  • Performing site support activities such as environmental monitoring, compressed gas and water system sampling within the graded manufacturing area
  • Planning, scheduling, and coordinating microbiological sampling and testing activities to support manufacturing operations, including routine monitoring, batch-related testing, and time-critical samples, ensuring alignment with production schedules and testing timelines
  • Carrying out a variety of routine microbiological techniques on utilities including but not limited to bioburden, endotoxin, TOC, conductivity and growth promotion testing on incoming microbial media
  • Responsible for micro release testing on raw materials, in-process drug substance and final product samples
  • Evaluating and reviewing test results for conformance to appropriate specifications and highlighting any suspect results to the QC Lab Manager
  • Participating in identification, investigation (deviations/out of specifications) and resolution of problems in the microbiology lab
  • Authoring method verification protocols, SOPs, WIs and TMs based on industry standard compendial methods
What we offer
What we offer
  • Equity
  • Annual bonus dependent on team and company performance
  • 6% (non-match) RRSP contribution
  • CAD $1,500 annual Active Lifestyle Allowance
  • Annual vacation
  • Professional development opportunities
  • Comprehensive health benefits
  • Scientific and technical mentorship
  • Teams and social groups to build community and connections
  • Fulltime
Read More
Arrow Right

Microbiological analyst

To be responsible for the microbiological test of raw materials, intermediate, f...
Location
Location
China , Wuxi
Salary
Salary:
Not provided
pfizer.de Logo
Pfizer
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • College degree or above, major in pharmaceutical / bioengineering/biotechnology or other biological related work experience
  • Master Pfizer Quality Standards, Good Manufacturing Practices and related regulations
  • Have good English and computer application ability
  • To be cooperative and have sense of responsibility
  • Have capability of communication and training.
Job Responsibility
Job Responsibility
  • Perform microbiological related test of raw materials, intermediate, finished products and inner package material
  • Be responsible for the original analysis result
  • Be responsible for the preparation of reagents, media, rinse fluid and so on
  • Be responsible for the validity of reagents, media and rinse fluid
  • Responsible for the management of laboratory strains, passaging and storing strains according to requirements
  • Perform method validation and product stability study
  • Be responsible for the usage, calibration, cleaning and maintenance of the instruments
  • Perform the sampling and monitoring of the water system,pure steam and compress gas system
  • Be responsible for initial and maintenances the related Standard Operating Procedure, test method and assist in preparation of product quality and chemical test technical document
  • Be responsible for organizing the preparation of technical documents related to quality or chemical test and the management and filing of those documents
  • Fulltime
Read More
Arrow Right
New

Senior Lecturer/Associate Professor in Literacy

As a Senior Lecturer / Associate Professor in Literacy, you will play a key role...
Location
Location
Australia , Albury-Wodonga, Bathurst, Port Macquarie, Wagga Wagga
Salary
Salary:
Not provided
csu.edu.au Logo
Charles Sturt University
Expiration Date
June 08, 2026
Flip Icon
Requirements
Requirements
  • A doctoral qualification relevant to literacy or education, with a recognised teaching qualification
  • A strong record of high-quality teaching and student-centred learning
  • An established or emerging research profile aligned to literacy, curriculum or pedagogy
  • The ability to build productive partnerships and contribute to academic leadership
Job Responsibility
Job Responsibility
  • Lead impactful literacy teaching and research
  • Teach across online and on-campus environments
  • Shape future teachers and education practice
  • Contribute to curriculum innovation
  • Build strong relationships with students and partners
  • Provide academic leadership in literacy education
  • Contribute to the School's research profile
  • Supervise higher degree research students
  • Actively engage with professional, community and government stakeholders
  • At Associate Professor level: significant academic leadership, research impact, and contribution to the broader discipline at national/international level
What we offer
What we offer
  • 17% superannuation
  • Fulltime
Read More
Arrow Right
New

Program Manager - Controls and Avionics Solutions

This position is based in Endicott, New York. New York and on-site work will be ...
Location
Location
United States , Endicott
Salary
Salary:
120874.00 - 205486.00 USD / Year
baesystems.com Logo
Baesystems
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in engineering, engineering or manufacturing management, or other discipline
  • Demonstrated ability for building strong customer/ stakeholder relationships
  • Strong communication, negotiation, and presentation skills
  • Ability to interpret data and make data-driven decisions
  • Highly adaptable with strong initiative
  • Demonstrated ability to lead and motivate cross-functional teams
  • Knowledge of the global aviation market and regulatory requirements and/ or military aviation market
Job Responsibility
Job Responsibility
  • Maintaining strong customer relationships and leading a multidisciplinary team to execute complex development programs within schedule and budget
  • Leadership and management oversight of a project team assuring that project’s financials, schedule, and technical objectives are met and that the highest level of customer satisfaction is achieved while meeting all contractual commitments
  • Work effectively and collaboratively with Engineering, Operations, and all Program Office functional leadership to assure deliveries continue to exceed customer commitments and achievement of financial commitments to the company
  • Manages, coordinates, plans, organizes, controls, integrates, and executes projects within the Military Aircraft Systems portfolio
  • Participates in the support of new business and in the development of proposals
What we offer
What we offer
  • Health insurance
  • Dental insurance
  • Vision insurance
  • Health savings accounts
  • 401(k) savings plan
  • Disability coverage
  • Life and accident insurance
  • Employee assistance program
  • Legal plan
  • Discounts on home, auto, and pet insurance
  • Fulltime
Read More
Arrow Right
New

Finance Business Partner (Research)

Full Time, Fixed Term (12 months). Level 7 - $101,421 to $110,819 p.a. (plus 17%...
Location
Location
Australia , Wagga Wagga
Salary
Salary:
101421.00 - 110819.00 AUD / Year
csu.edu.au Logo
Charles Sturt University
Expiration Date
June 02, 2026
Flip Icon
Requirements
Requirements
  • A degree in Accounting or Finance (professional accounting body membership is desirable)
  • Experience in project budgeting, forecasting and financial analysis
  • Background in management accounting or business partnering within complex environments
  • exposure to government funding or higher education is advantageous
  • Excellent stakeholder engagement skills, with the ability to work effectively with academics and researchers
  • Familiarity with business intelligence systems and dashboard reporting
Job Responsibility
Job Responsibility
  • Partner with academics to deliver strategic financial insights that enable research success
  • Directly influence world-class projects and decisions shaping the future of education and innovation
  • Lead initiatives that enhance financial governance, deliver accurate and timely reporting, and support key projects such as cost-pricing systems and research budgeting
  • Help build financial capability across the University, fostering collaboration and continuous improvement
What we offer
What we offer
  • Flexibility with a 35-hour work week
  • Access to hybrid work arrangements
  • 17% superannuation
  • Fulltime
Read More
Arrow Right
New

Associate Lecturer/ Lecturer in Oral Health

Make a real impact by educating future oral health professionals to serve the ur...
Location
Location
Australia , Wagga Wagga
Salary
Salary:
80046.00 - 134965.00 AUD / Year
csu.edu.au Logo
Charles Sturt University
Expiration Date
June 16, 2026
Flip Icon
Requirements
Requirements
  • A qualification relevant to the discipline and appropriate to the level being applied for
  • Full registration (for teaching/research) as a Dentist or Oral Health Therapist with the Australian Health Practitioner Regulation Agency (Ahpra)
  • Excellent understanding of the clinical practice of oral health therapy, supported by a record of teaching and subject coordination relevant to the discipline and appropriate to the level being applied for
  • Evidence of the delivery of high quality student-centred learning and teaching in oral health therapy and/or general dentistry
  • A record of research activity or capability relevant to the discipline and appropriate to the level being applied for, as outlined in the position descriptions, may facilitate the progression of research opportunities
Job Responsibility
Job Responsibility
  • deliver high-quality teaching, clinical supervision and learning experiences in Oral Health
  • work with students in both clinical and preclinical settings while contributing to curriculum development, industry engagement and community partnerships
What we offer
What we offer
  • Generous support provided to assist with relocating to Riverina’s beautiful Wagga Wagga or surrounds
  • 17% superannuation
  • Fulltime
Read More
Arrow Right
New

Change Analyst

As Change Analyst you will provide specialist change management expertise to sup...
Location
Location
Australia , Albury-Wodonga, Bathurst, Dubbo, Orange, Wagga Wagga
Salary
Salary:
101421.00 - 110819.00 AUD / Year
csu.edu.au Logo
Charles Sturt University
Expiration Date
June 03, 2026
Flip Icon
Requirements
Requirements
  • Relevant qualifications and/or equivalent experience in organisational change and transformation
  • Experienced in applying change management frameworks and methodologies to large-scale/complex organisational initiatives
  • Skilled in analysing change impacts and shaping clear, targeted responses in policy-driven environments
  • Strong communication and interpersonal skills
Job Responsibility
Job Responsibility
  • Provide specialist change management expertise to support the successful planning and implementation of the Models of Engagement and Assessment initiative
  • Lead change analysis, stakeholder engagement planning and adoption activities to enable a sustainable transition to new models of course delivery and assessment.
What we offer
What we offer
  • Competitive salary and benefits including 17% super
  • Flexible working arrangements that support a healthy work-life balance
  • Fulltime
Read More
Arrow Right