QC & Analytical Manager - ELISA Job at Cranleigh STEM (Berkshire)

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

Associate Quality Control

At Amgen, if you feel like you’re part of something bigger, it’s because you are...

Location

United States , Thousand Oaks

Salary:

62571.90 - 84656.10 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school/GED + 2 years of Quality experience OR Associate’s + 6 months of Quality experience OR Bachelor’s

Job Responsibility

Responsible for one or more of the following activities in QC: analytical testing, sample and data management and equipment maintenance
Perform routine laboratory procedures such as sample analysis, standard and solution preparation
Responsible for documenting, compiling, interpreting, reviewing and entering laboratory data
Providing and communicating results, maintaining/operating specialized equipment and drafting and revising documents such as Analytical Methods, SOPs and technical reports
Support introduction of new methods/techniques into the lab
Perform basic assay and instrument troubleshooting

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible

Fulltime

Director / Senior Director, Quality Control Automation & Digitalization

We are seeking a Director / Senior Director, Quality Control Automation and Digi...

Location

United States , Cambridge

Salary:

210000.00 - 320000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Advanced degree (PhD preferred) with 15+ years of relevant experience in Quality Control, laboratory automation, and pharmaceutical or biotechnology operations, including 8+ years in progressively responsible leadership roles with demonstrated advancement to Director‑level scope
Extensive hands‑on automation experience, including 8+ years working with liquid handling platforms (e.g., Hamilton, Tecan), with demonstrated expertise in script development, validation, troubleshooting, and lifecycle management within GMP environments
Proven expertise integrating automated workflows with LIMS and other enterprise digital systems to support compliant data management and end‑to‑end process automation
Deep technical understanding of molecular biology, cellular, and immunoassay techniques, including transfection/transduction workflows, ddPCR/qPCR, flow cytometry, ELISA, and next‑generation sequencing (NGS)
Strong track record leading cross‑functional automation initiatives in regulated biopharmaceutical settings, including oversight of instrument and software IQ/OQ/PQ, analytical method qualification and validation, and method lifecycle management
Demonstrated success in building, leading, and developing high‑performing technical teams, with a proven ability to mentor, coach, and retain top talent
Exceptional communication and influence skills, with the ability to engage senior leadership and align diverse stakeholder groups around complex technical and operational initiatives
Strategic mindset with the ability to translate business and portfolio needs into scalable automation strategies, roadmaps, and executable plans

Job Responsibility

Serve as the QC Automation Lead, providing deep technical expertise and strong compliance acumen to design, deploy, and sustain automation and digital solutions supporting GMP analytical methods and procedures
Partner strategically with cross‑functional stakeholders—including Analytical Development, Automation, Computational Biology, Quality Control, Quality Assurance, Information Technology, and Validation—to define and implement integrated, end‑to‑end automation workflows
Oversee the full lifecycle of automated solutions, including instrumentation and software onboarding, qualification, and validation
robust script development and testing
and technical transfer, qualification, and validation of automated analytical methods. This includes complex modalities such as cell‑based functional assays, flow cytometry, ddPCR, ELISA, and NGS
Drive alignment on deliverables and exit criteria across Research, Development, and Commercial phases, including pre-qualification package signoffs, SME training completion, and qualification package approvals
Direct and facilitate investigation and resolution of complex technical challenges related to automated systems, ensuring scientific rigor, data integrity, and compliance with GMP expectations
Design and implement comprehensive training programs to build QC capability and confidence in automated and digital platforms, ensuring strong scientific and technical understanding across the organization
Mentor and develop team members in the design, authoring, execution, and lifecycle management of automated analytical protocols within GMP environments
Establish and maintain technical standards, best practices, and governance for automation scripting, validation documentation, system lifecycle management, and troubleshooting methodologies

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

Senior Research Associate

Seeking a QC Senior Research Associate with broad knowledge and expertise in ana...

Location

United States , San Diego

Salary:

60.00 - 69.00 USD / Hour

Beacon Hill

Expiration Date

Until further notice

Requirements

BS or equivalent in relevant discipline with a minimum of 2-5 years of relevant industry experience or Master’s degree in relevant discipline with a minimum of 0-1 years of relevant industry experience
Experience in pharmaceutical industry with a GMP testing focus, ideally covering the analytical method and testing lifecycle from development through commercial drug product testing, with experience in a GMP QC release testing role
Experience in optimizing methods with particular emphasis on cell-based potency assay, molecular biology assay, and protein chemistry assays
Significant experience in an FDA-regulated environment
Entrepreneurial spirit, with strong willingness to take on new challenges required to bring novel medicines to the clinic
Excellent organizational and communication skills

Job Responsibility

Collaborate with research, analytical development and process development teams to develop, qualify/validate AAV gene therapy analytical/molecular biology assays, chemical/biochemical assays, and cell-based biological potency assays, for process monitoring and product release and stability, e.g., compendial methods, HPLC, DLS, droplet digital PCR or qPCR, ELISA, and cell‑based potency assays
Participate in developing timelines, protocols and reports for assay transfers, qualifications/validations Contribute to establishing material specifications for drug substance and drug products
Author and review QC analytical/equipment SOPs, protocols, and reports as needed
Ensure the timely execution of all routine QC testing, data review, and preparation of summary reports May act as an analytical lab representative on a CMC team
Perform quality management activities such as deviation, CAPA, change control, investigation of OOS, OOT and anomalous results within the company QMS according to established procedures.
Maintain QC laboratory, track critical reagents and equipment logbooks, and ensure all the equipment is calibrated
Utilize the LIMS system to submit samples, enter data, and track samples.
Utilize statistical analysis software to generate assay control charts and recommend assay acceptance criteria.
Learn and become proficient in all laboratory instrument software to conduct testing

Manufacturing QA Chemist

The Manufacturing QC Chemist is responsible for supporting Quality Control and Q...

Location

United States , Brownsburg

Salary:

24.00 USD / Hour

Antech Diagnostics

Expiration Date

Until further notice

Requirements

Associates degree required/ bachelor’s degree in science related discipline preferred
Experience with general laboratory and IVD manufacturing equipment
Knowledge of GMP, GLP, & GDP standards
Experience handling hazardous chemicals
Experience in general reagent compounding or buffer preparation
Proficiency in laboratory techniques, including precision filling and pipetting
Familiarity with molecular assays (PCR, ELISA, radioactive, fluorescent)
Strong statistical analysis skills
High attention to detail and commitment to work quality
Effective problem-solving abilities

Job Responsibility

Perform visual inspections and laboratory analyses to verify product quality and compliance
Perform laboratory assays (e.g., PCR, ELISA, radioactive/fluorescent assay) and support validation of new & existing products and processes
Document, report, and investigate non-conformance issues
perform root cause analysis and recommend corrective actions
Monitor QC parameters using statistical tools (e.g., Levy-Jennings charts) and maintain accurate records in QA databases
Calibrate, maintain, and troubleshoot laboratory equipment and instrumentation
Handle hazardous chemicals and small quantities of radioactive materials in accordance with safety and regulatory guidelines (e.g., NRC regulations)
Assist with sample collection, validation studies, and initial data review for new & existing products
Support method and assay validation, including analytical testing and documentation
Participate in internal audits and continuous improvement initiatives within manufacturing and Biobank facilities

What we offer

Paid Time Off & Holidays
Medical, Dental, Vision (Multiple Plans Available)
Basic Life (Company Paid) & Supplemental Life
Short and Long Term Disability (Company Paid)
Flexible Spending Accounts/Health Savings Accounts
Paid Parental Leave
401(k) with company match
Tuition/Continuing Education Reimbursement
Life Assistance Program
Pet Care Discounts

Fulltime

Pharmaceutical Automation Engineer

We are seeking a highly skilled and proactive Automation Specialist to join our ...

Location

Canada , Toronto

Salary:

50000.00 - 80000.00 / Year

Amaris Consulting

Expiration Date

Until further notice

Requirements

Master's degree in Science, Applied Science, Robotics, Mechanical Engineering, or High-Throughput Assay Development (preferred)
3+ years of hands-on experience in laboratory automation, with strong expertise in Hamilton systems
Proven success in developing, scaling, and optimizing automated liquid handling systems to improve throughput and resource efficiency
Expertise in automating complex liquid handling workflows using Hamilton platforms, SoftMax Pro, and digital laboratory tools
Proficiency in Python and JavaScript to develop automated scripts and reduce manual work
Strong mechanical aptitude applicable to laboratory automation equipment and integration of multiple devices into cohesive workflows
Familiarity with data pipelines, database management (SQL/NoSQL), and system integration to enhance automation performance

Job Responsibility

Manage and schedule activities within the automation service unit, including intake of automation requests, development planning, routine activities, and maintaining a prioritized worklist
Set up and maintain KanBan boards, Jira tickets, and lead weekly scrums to communicate progress, delays, or completions to stakeholders
Independently create robotic protocols in Venus 4+ for Hamilton liquid handlers
Create, update, and maintain SoftMax Pro protocols in a non-GxP environment, including automated calculations, statistics, and final results
Program and support integration software such as Green Button Go or Genera
Work with cross-functional teams to translate technical methods or scientific requirements into automated laboratory workflows
Maintain detailed user stories, programming notes, and identify opportunities for continuous improvement
Ensure precise definition of data outputs, file structures, and promote good data stewardship practices
Demonstrate familiarity with pharmaceutical, biopharmaceutical, or analytical QC tests such as ELISAs, protein assays, and related methods

What we offer

An international community bringing together more than 110 different nationalities
An environment where trust is central: 70% of our leaders started their careers at the entry level
A strong training system with our internal Academy and more than 250 modules available
A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.)

Fulltime

Quality Control Specialist

The QC Associate I is responsible for performing routine, accurate, and timely t...

Location

United States , San Diego

Salary:

Not provided

MillenniumSoft Inc

Expiration Date

Until further notice

Requirements

Minimum of 2 years of laboratory experience (academic and industry combined)
Hands-on experience with ELISA or CBA techniques is required
Experience in a QC environment is preferred
knowledge of Western Blot, Flow Cytometry, and Cell/Tissue culture is a plus
Intermediate computer skills (MS Windows, database management systems)
Knowledge of general laboratory safety practices
Strong analytical and problem-solving abilities
Effective written and verbal communication skills
Ability to follow established protocols and maintain accurate records
BS/BA/MS in a related scientific discipline or completion of science-related college coursework

Job Responsibility

Perform routine QC testing using ELISA or CBA techniques
Train to become proficient in QC methods, equipment operation, and data reporting
Work with human blood, mammalian cell cultures, animal tissues, and related samples
Analyze and report test results, completing all required documentation and database entries
Calibrate and maintain laboratory equipment and assist with troubleshooting
Prepare lab supplies and reagents, and support laboratory maintenance
Ensure compliance with safety protocols and participate in Environmental, Health & Safety programs
Identify and address hazards, reporting any unsafe work practices
Participate in cross-training, departmental projects, and team assignments
Perform other duties as required

Fulltime

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QC & Analytical Manager - ELISA

Job Description

Job Responsibility

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