CrawlJobs Logo

Manager Quality Control - Biochemistry Labs

Amgen

Location Icon

Location:
United States, Juncos

Category Icon
Category:
Quality Control

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

New

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
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
New

Associate Quality Control (Analytical)

Amgen is one of the world’s leading independent biotechnology companies. For ove...
Location
Location
Singapore , Tuas
Salary
Salary:
Not provided
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s Degree in Chemistry, Biochemistry, Life Science or related technological field and 2 years of directly related experience
  • Associate’s Degree in Chemistry, Biochemistry, Life Science or related technological field and 4 years of directly related experience
  • 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
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
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
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

Quality Control Analyst

Are you a Quality Control Analyst interested in joining a big global pharmaceuti...
Location
Location
Greece , Schimatari
Salary
Salary:
Not provided
https://www.randstad.com Logo
Randstad
Expiration Date
December 30, 2025
Flip Icon
Requirements
Requirements
  • Ensuring accuracy in documentation and test results
  • Proficiency in laboratory software and data management
  • Ability to clearly report and interpret test results
  • Bachelor's degree in chemistry, biochemistry, pharmacy, or a related field
  • Familiarity with lab techniques like HPLC, GC, and spectroscopy
  • Understanding of Good Manufacturing Practices and regulatory guidelines
  • Ability to conduct precise and accurate testing
Job Responsibility
Job Responsibility
  • GLP document preparation e.g. SOPs, Specification and Method of Analysis, Certificate of Analysis etc.
  • Good documentation practices and record keeping of all GMP documents / logs. (RM, PM, IP, FP sampling and testing)
  • Sampling and testing: RM, PM, FP and stability samples
  • Stability sample management and stability protocol preparation
  • Daily calibration and verification checks for QC instruments
  • Impurity and standard managements
  • Daily monitoring of data loggers and recording
  • Management of HPLC/GC Columns
  • Procurement of Laboratory chemicals & consumables
Read More
Arrow Right
New

Speech Language Pathologist

The Speech Language Pathologist is a registered professional who provides therap...
Location
Location
United States , Granby
Salary
Salary:
Not provided
angelscarehealth.com Logo
Angels Care Home Health
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Master’s degree in Speech Language Pathology from an accredited college or university
  • Current state license in Speech Language Pathology
  • Certificate of Clinical Competence from American Speech Language Hearing Association
  • Valid driver’s license
  • 2 years’ experience in an acute care or rehabilitation setting, home health preferred
  • Reliable transportation with current auto liability insurance
Job Responsibility
Job Responsibility
  • Provides coordinated care to patients in their place of residence
  • Plans, implements, and evaluates patient care plans to restore or maintain patient well-being
  • Collaborates with interdisciplinary team
Read More
Arrow Right
New

Certified Occupational Therapy Assistant

Certified Occupational Therapy Assistant (COTA) for Angels Care Home Health. The...
Location
Location
United States , Neosho
Salary
Salary:
Not provided
angelscarehealth.com Logo
Angels Care Home Health
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Graduate from an Accredited Collegiate Occupational Therapy Assistant Program with a Science or Applied Science Degree
  • Current licensure in state of practice as an Occupational Therapy Assistant (OTA) or Certified Occupational Therapy Assistant (COTA)
  • 1 year experience as a Certified Occupational Therapy Assistant preferred
  • Strong interpersonal skills
  • Proof of current CPR and Hepatitis profile
  • Valid driver license with current auto liability insurance
  • Reliable transportation
Job Responsibility
Job Responsibility
  • Provides coordinated occupational therapy to patients in their place of residence under the supervision of a licensed Occupational Therapist
  • Parttime
Read More
Arrow Right
New

Physical Therapist

Why choose Angels Care Home Health? Angels Care Home Health has a simple philoso...
Location
Location
United States , Maryville
Salary
Salary:
Not provided
angelscarehealth.com Logo
Angels Care Home Health
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Current state license as a Physical Therapist
  • Two years of experience as a Physical Therapist
  • Current CPR and Hepatitis profile
  • Knowledge of durable medical equipment
Job Responsibility
Job Responsibility
  • Plans, implements, and evaluates patient care plans to restore or maintain patient well-being
  • Plans, organizes, and conducts physical therapy treatment programs based on the medical referral and their evaluation
  • Collaborates with interdisciplinary team
What we offer
What we offer
  • Monday through Friday Schedule
  • Salary + Vehicle Allowance + Performance Bonuses (Full-Time)
  • Full Health, Dental, & Vision Benefits (Full-Time)
  • Generous Paid Time Off
  • Extensive Training
  • Company-Matched 401(k)
  • Career Advancement
Read More
Arrow Right
New

Occupational Therapist

Angels Care Home Health is a Medicare Certified Home Health agency providing qua...
Location
Location
United States , Maryville
Salary
Salary:
Not provided
angelscarehealth.com Logo
Angels Care Home Health
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Current state license as an Occupational Therapist
  • Two years of experience as an Occupational Therapist
  • Current CPR and Hepatitis profile
  • Knowledge of durable medical equipment
Job Responsibility
Job Responsibility
  • Perform clinical assessment
  • Identify patient needs and appropriateness of patient
  • Document, prepare, and complete a Plan of Care, progress notes, and other clinical record documentation on an ongoing basis
  • Revise the POC based on evaluation and ongoing assessment
  • Applies concepts of infection control and universal precautions in coordinating/performing patient care
  • Accepts clinical assignments that are consistent with education and competence to care for patients
  • Uses effective interpersonal relations and communication skills
  • facilitates the use of these skills by other team members to achieve desirable outcomes
  • Assess physical, social, and cultural components of the patient’s occupational environment
  • Parttime
Read More
Arrow Right
Welcome to CrawlJobs.com
Your Global Job Discovery Platform
At CrawlJobs.com, we simplify finding your next career opportunity by bringing job listings directly to you from all corners of the web. Using cutting-edge AI and web-crawling technologies, we gather and curate job offers from various sources across the globe, ensuring you have access to the most up-to-date job listings in one place.