CrawlJobs Logo

Manager Quality Control - Biochemistry Labs

amgen.com Logo

Amgen

Location Icon

Location:
United States , Juncos

Category Icon

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided

Job Description:

Lead all Biochemistry laboratories during the night shift (including Wet Chemistry and HPLC Labs) —ensuring compliant, accurate testing and fostering an impactful team that safeguards product quality and patient safety.

Job Responsibility:

  • Lead and develop a successful QC team, fostering a culture of safety, compliance, and continuous improvement
  • Oversee daily QC operations to ensure timely, accurate, and reliable testing aligned with production schedules
  • Serve as the QC subject matter expert during audits and inspections, ensuring inspection readiness
  • Provide technical guidance and troubleshooting support for complex assays and testing issues
  • Drive training initiatives and ensure team members are appropriately cross-trained for operational flexibility
  • Monitor assay results and documentation to ensure compliance with cGMP, SOPs, and regulatory standards
  • Communicate clear expectations on safety, quality, and compliance, addressing discrepancies promptly
  • Organize and prioritize team tasks based on impact and deadlines, adjusting as needed to meet changing requirements
  • Use data and dashboards to monitor QC performance metrics, identify trends, and implement improvements
  • Collaborate with cross-functional stakeholders to align QC activities with broader site and organizational goals
  • Empower team members through coaching, feedback, and development plans tailored to individual strengths
  • Promote continuous improvement initiatives to optimize workflows, increase efficiency, and reduce cycle times

Requirements:

  • Doctorate degree
  • Or Master’s degree and 3 years of Manufacturing Support, Quality Control and/or Laboratory experience
  • Or Bachelor’s degree and 5 years of Manufacturing Support, Quality Control and/or Laboratory experience
  • Or Associate’s degree and 10 years of Manufacturing Support, Quality Control and/or Laboratory experience
  • Or High school diploma / GED and 12 years of Manufacturing Support, Quality Control and/or Laboratory experience
  • Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Nice to have:

  • Educational background in Life Sciences, Chemistry, Biochemistry, or related fields
  • Experience in Quality and/or Laboratory operations within a GMP environment
  • Expertise in overseeing biochemistry laboratory operations, including Wet Chemistry and HPLC testing
  • Strong knowledge of analytical techniques such as HPLC, TOC, UV spectroscopy, pH, conductivity, appearance, color, clarity, polysorbate, physical methods
  • Familiarity with laboratory systems such as LIMS, LMES, CIMS, and Empower for HPLC data management
  • Knowledge of method transfer and validation activities
  • Proven ability to optimize schedules and improve laboratory efficiency and productivity
  • Strong people management skills, including team development, coaching, and engagement
  • Demonstrated ability to balance working both independently and in teams, driving cross-shift collaboration and efficiency with other managers within the organization
  • Highly collaborative leadership style with experience working effectively across diverse departmental groups
  • Excellent communication skills (written and verbal) in English and Spanish
  • ability to facilitate and present effectively
What we offer:
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
  • 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 and an annual site shutdown

Additional Information:

Job Posted:
December 18, 2025

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:

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

Briefcase Icon

Similar Jobs for Manager Quality Control - Biochemistry Labs

Manager Quality Control - HPLC Labs

Lead the HPLC Labs during the 2nd shift —ensuring compliant, accurate testing an...
Location
Location
United States , Juncos
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree
  • OR Master’s degree and 3 years of Manufacturing Support, Quality Control and/or Laboratory experience
  • OR Bachelor’s degree and 5 years of Manufacturing Support, Quality Control and/or Laboratory experience
  • OR Associate’s degree and 10 years of Manufacturing Support, Quality Control and/or Laboratory experience
  • OR High school diploma / GED and 12 years of Manufacturing Support, Quality Control and/or Laboratory experience
  • Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
  • Educational background in Life Sciences, Chemistry, Biochemistry, or related fields
  • Experience in Quality and/or Biochemistry Laboratory operations within a GMP environment, preferably in HPLC testing
  • Strong knowledge of analytical techniques such as HPLC
  • Familiarity with laboratory systems such as LIMS, LMES, CIMS, and Empower for HPLC data management
Job Responsibility
Job Responsibility
  • Lead and develop a successful QC team, fostering a culture of safety, compliance, and continuous improvement
  • Oversee daily QC operations to ensure timely, accurate, and reliable testing aligned with production schedules
  • Serve as the QC subject matter expert during audits and inspections, ensuring inspection readiness
  • Provide technical guidance and troubleshooting support for complex assays and testing issues
  • Drive training initiatives and ensure team members are appropriately cross-trained for operational flexibility
  • Monitor assay results and documentation to ensure compliance with cGMP, SOPs, and regulatory standards
  • Communicate clear expectations on safety, quality, and compliance, addressing discrepancies promptly
  • Organize and prioritize team tasks based on impact and deadlines, adjusting as needed to meet changing requirements
  • Use data and dashboards to monitor QC performance metrics, identify trends, and implement improvements
  • Collaborate with cross-functional stakeholders to align QC activities with broader site and organizational goals
What we offer
What we offer
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
  • 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 and an annual site shutdown
  • Flexible work models where possible
  • Fulltime
Read More
Arrow Right

Senior Director, Quality Control Analytical Sciences

We are seeking a Senior Director, Quality Control (QC) Analytical Sciences, to l...
Location
Location
Salary
Salary:
245000.00 - 260000.00 USD / Year
apogeetherapeutics.com Logo
Apogee Therapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • PhD in relevant discipline (e.g., analytical biochemistry or relevant field)
  • 15+ years of QC experience with complex biologics, particularly monoclonal antibodies, spanning late-stage development and commercialization
  • Proven people leader with a growth mindset, willing to learn from others, and dedication to promoting a psychologically safe environment
  • Excellent communicator with an ability to present to and be understood by a variety of stakeholders and tailor message accordingly
  • Experience with regulatory filing preparation and messaging across global jurisdictions
  • Deep knowledge and understanding of relevant global regulatory guidance and requirements
  • Ability to keep pace with a fast-moving organization
  • Availability to participate in calls across multiple international time zones
  • Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
  • Ability and willingness to travel up to 30%
Job Responsibility
Job Responsibility
  • Lead QC Analytical Sciences team, responsible for QC activities for all pipeline programs including strategies for phase-appropriate method qualification, validation, and transfer for drug substance, drug product, and drug-device combination testing
  • in-process/release/stability testing
  • specification justification and maintenance
  • shelf-life management
  • and critical documentation
  • Partner with new and existing external QC testing labs and CDMOs, managing relationships and all relevant activities in collaboration with TechOps Program Management, Quality Assurance, and Manufacturing
  • Develop analytical regulatory strategies and prepare relevant Module 3 regulatory documents
  • Contribute to a mature QC infrastructure, implementing processes and procedures to support the development of therapeutic candidates in a GMP-compliant manner
  • Monitor data trends, troubleshoot QC method performance, and investigate OOT/OOS results
What we offer
What we offer
  • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
  • three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
  • Commitment to growing you professionally and providing access to resources to further your development
  • Apogee offers regular all team, in-person meetings to build relationships and problem solve
  • Fulltime
Read More
Arrow Right

Laboratory Technician

We're seeking a motivated and detail-oriented Laboratory Technician to join our ...
Location
Location
United States , Cincinnati
Salary
Salary:
41600.00 - 42600.00 USD / Year
bhsg.com Logo
Beacon Hill
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in a scientific field preferred (e.g., Biology, Chemistry, Biochemistry, or related discipline)
  • work experience in a laboratory environment will also be considered in lieu of degree
  • Previous laboratory experience preferred (academic or professional)
  • Familiarity with standard lab equipment and procedures
  • Strong attention to detail and excellent organizational skills
  • Ability to follow written and verbal instructions accurately
  • Effective communication and teamwork skills
Job Responsibility
Job Responsibility
  • Perform laboratory tests and procedures according to standard operating protocols
  • Prepare samples, reagents, and documentation for analysis
  • Accurately record and report data in compliance with lab standards
  • Calibrate and maintain laboratory instruments and equipment
  • Assist in inventory management and ordering of lab supplies
  • Support general lab maintenance and cleanliness to ensure a safe working environment
  • Fulltime
Read More
Arrow Right
New

Sr. QC Associate I

10x Genomics is looking for a Sr. QC Associate I to join our Quality Control tea...
Location
Location
United States , Pleasanton
Salary
Salary:
37.64 - 50.91 USD / Hour
10xgenomics.com Logo
10x Genomics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • B.S. in Analytical Chemistry, Biochemistry, or a related field
  • 5+ years of laboratory experience specifically in a QC environment
  • Strong hands-on experience with NGS and tissue-based assays (including immunofluorescence and flow cytometry)
  • Proficiency in PCR, qPCR, spectrophotometry, spectrofluorometry, and HPLC
  • Experience collaborating with R&D and QA on risk-based QC strategy assessment including assay robustness, assay cost, and alignment of QC checkpoints to the manufacturing process
  • A solid understanding of New Product Introduction (NPI) and manufacturing processes
  • Ability to manage and track diversified QC assays and projects in a rapidly evolving environment
  • Strong critical thinking, logical problem-solving skills, and the ability to communicate effectively with stakeholders
Job Responsibility
Job Responsibility
  • Execute QC Testing: Perform quality control operations according to defined procedures to ensure the integrity and quality of raw materials, intermediates, and finished goods
  • Data Analysis & Disposition: Complete QC testing in a timely manner and disposition materials based on established acceptance criteria
  • Product Development and Sustaining Support: Serve as the primary QC point of contact to oversee project completion, providing expert guidance on assay setup and assisting in the introduction and optimization of new products and processes
  • Assay Cross-Training: Cross-train on various inspections, including first article inspection, metrology, microscopy, analytical assays, and NGS
  • Documentation: Maintain quality control batch records and ensure Good Documentation Practices (GDP) under ISO requirements. Accurately track QC test data, calibration records, and inventory. Draft Work Instructions in collaboration with the Manufacturing Systems & Engineering team
  • Quality Compliance: Initiate non-conformance, deviation reports, engineering change orders (ECO) and follow up on necessary action items. Ensure that lab operations and workflow execution are compliant with ISO requirements
  • Problem Solving: Effectively identify and communicate complications arising from QC testing with minimal supervision. Work closely with scientists to establish and maintain technical solutions. Drive completion of investigations and minimize disruptions to QC operations
What we offer
What we offer
  • Equity grants
  • Comprehensive health and retirement benefit programs
  • Annual bonus program or sales incentive program
  • Generous time off
  • Competitive and comprehensive health benefits package
  • Family friendly policies like parental leave
  • Fulltime
Read More
Arrow Right

Laboratory Technician

As a Laboratory Technician working onsite in the Resin QC Laboratory in Delaware...
Location
Location
United States of America , Delaware
Salary
Salary:
Not provided
ppg.com Logo
PPG Industries
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree required
  • Degree in Chemistry, Biochemistry, Chemical Engineering
  • 1 year of academic or professional laboratory experience to apply laboratory methods
  • Work weekends as dictated by business need
  • Work additional overtime as determined by business and project needs
Job Responsibility
Job Responsibility
  • Troubleshoot batch QC result abnormalities
  • Test all production samples – following SOPs as defined, performing test methods, and recording all test results
  • Support project and continuous improvement work to help maintain project timelines
  • Understand customer requirements and determine adjustments for batches
  • Collaborate with other QC teams, production, and technical groups to independently disposition batches
  • Maintain all laboratory equipment and perform required calibrations as assigned
  • Use immediate production and project need to prioritize daily activities
  • Maintain lab ancillary inventory, daily material stocking needs, and contribute to 6S
  • Understand and maintain Delaware's Quality Management System requirements
  • Support Departmental X matrix action items as assigned
What we offer
What we offer
  • Medical
  • Dental
  • Vision
  • 401K
  • Fulltime
Read More
Arrow Right

Senior Research Associate I, Services

We're in search of an exceptional Senior Research Associate I to join our Transl...
Location
Location
United States , Pleasanton
Salary
Salary:
97700.00 - 132100.00 USD / Year
10xgenomics.com Logo
10x Genomics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • B.S. or equivalent, in Microbiology, Molecular Biology, Biochemistry, or a related field with 3+ years lab experience
  • Experience working in similar positions in an industry service provider/core facility
  • Experience with molecular biology techniques and related equipment, including NGS library preparation workflows, flow cytometry, microscopy, high-throughput single cell genomics (e.g. QuantumScale, 10x Genomics Chromium assays)
  • A proven track-record of using, optimizing and troubleshooting molecular biology protocols
  • Strong customer service orientation, with a commitment to project success
  • Demonstrated flexibility in collaborating with cross-functional internal groups
  • Strong organizational skills and ability to plan and structure your work
  • Excellent interpersonal skills, including written and oral communication
  • Ability to work in a fast-paced and quickly changing environment
  • Capacity for repetitive tasks
Job Responsibility
Job Responsibility
  • Perform single cell assays with a wide range of tissue inputs
  • Perform flow cytometry
  • Perform a variety of NGS library preparation workflows
  • Troubleshoot assays in collaboration with the assay team
  • Optimize protocols for specific tissue samples
  • Improve workflows and provide feedback to development and marketing teams
  • Deliver processed sequencing data to, and work closely with, computational biologists, project managers, and other scientific investigators
  • Generate and maintain meticulous laboratory records, SOPs, and batch records
  • Ensure work is conducted with appropriate quality controls
  • Manage sample receipt, tracking and storage
What we offer
What we offer
  • Equity grants
  • Comprehensive health and retirement benefit programs
  • Annual bonus program or sales incentive program
  • Generous time off
  • Competitive and comprehensive health benefits package
  • Easy-to-use benefits that promote wellbeing
  • Family friendly policies like parental leave
  • Fulltime
Read More
Arrow Right

Laboratory Manager

In this position, the successful candidate will oversee and guide the day-to-day...
Location
Location
United Kingdom , Cambridge
Salary
Salary:
Not provided
avantorsciences.com Logo
Avantor
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • A Bachelor’s degree in a scientific discipline, preferably Biochemistry, or equivalent laboratory experience
  • Proven excellent customer service focus and ability to work collaboratively
  • Clear and concise written and spoken communication skills
  • Ability to influence people at all levels to deliver improvements and cost savings to the customer
  • Some knowledge and experience of lean sigma processes is an advantage
  • Able to partner with other teams and suppliers and deliver results in a matrix environment, managing multiple internal and external partners/stakeholders.
  • Excellent problem-solving capabilities and confidence to make clear decisions sometimes with limited information.
  • Exceptional planning, organisational, analytical and networking skills.
  • Project management skills, ability to be flexible and handle multiple responsibilities and tasks on a regular basis
  • Proficient in data capture, analysis and reporting utilising various IT systems particularly Microsoft Excel
Job Responsibility
Job Responsibility
  • Operational day to day Laboratory management providing a ‘single point of contact‘ for laboratory scientists and external visitors
  • Ensures the laboratory maintains its operational efficiency by liaising with all FM suppliers - planning preventative and scheduled maintenance regimes with minimal impact to daily operations, ensuring any FM helpdesk requests are completed
  • Assists with organised visits from internal/external partners and regulatory bodies
  • Maintains and organises laboratory consumable inventories and provides reports to the Dept leadership team as requested
  • Performs laboratory inductions for internal/external and temporary lab users working in the area to familiarise them will lab policies and procedures
  • Provide operational support on projects to build understanding of business needs and identify opportunities for process improvements
  • Co-ordinate laboratory scientists to ensure 6-monthly laboratory cleans are completed effectively
  • Maintain and update the orientation plan for new starters
  • Knowledge or experience of equipment IQ/OQ/PQ
  • Serves as a committee member on several cross functional teams including: SHE Safety Committee, Operations Lab Rep meetings. Ensure relevant actions are implemented with Research labs
What we offer
What we offer
  • competitive salary and benefits package
  • flexible approach to work
  • Fulltime
Read More
Arrow Right

Manager, Bioanalytical Services

Manager, Bioanalytical Services- Full-Time, Onsite; Whitesboro, New York. ICON p...
Location
Location
United States , Whitesboro
Salary
Salary:
100472.00 - 125590.00 USD / Year
iconplc.com Logo
iconplc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s or advanced degree in Biochemistry, Pharmacology, or a related field
  • Proven experience in bioanalytical services, laboratory management, or a related role, with a strong understanding of GLP and regulatory requirements
  • Excellent leadership and team management skills, with the ability to oversee complex laboratory workflows
  • Strong problem-solving and organizational skills, with a focus on delivering high-quality data under tight deadlines
  • Effective communication and collaboration skills, with experience working in cross-functional project teams
Job Responsibility
Job Responsibility
  • Managing the day-to-day operations of the bioanalytical laboratory, ensuring timely and accurate analysis of clinical samples
  • Leading a team of scientists and lab technicians, providing mentorship and guidance to maintain high performance and scientific integrity
  • Overseeing the development and validation of bioanalytical methods in compliance with GLP and regulatory standards
  • Collaborating with cross-functional teams, including clinical and regulatory teams, to ensure alignment of bioanalytical activities with project goals
  • Ensuring all laboratory processes adhere to quality control procedures and regulatory requirements, and implementing continuous improvement initiatives
What we offer
What we offer
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others
  • Fulltime
Read More
Arrow Right