CrawlJobs Logo
Amgen Logo Amgen · Quality Control

Sr. Manager Quality Control - Chemistry

United States, Holly Springs Employment contract 142103.85 - 192258.15 USD / Year · Job Posted May 29, 2026
Apply Position
Job Link Share

Job Description

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Job Responsibility

  • Lead teams responsible for the QC Chemistry laboratory and 1st and 2nd shift Quality Control operations
  • Include the startup and validation of laboratory equipment, transfer and implementation of analytical methods, and development of a diverse team to support site startup and successfully transition into steady-state commercial operations at Amgen North Carolina
  • Overall responsibility for startup, operational readiness, and day-to-day management of the QC Chemistry laboratory and oversight of 1st and 2nd shift QC teams, including successfully transitioning the organization from site startup activities into routine commercial operations
  • Lead QC Chemistry functions supporting analytical method families including chromatography (HPLC/UPLC), capillary electrophoresis (CE), gel-based methods, and general compendial chemistry testing
  • Manage 1st and 2nd shift managers 7 days a week for cross functional night shift support for manufacturing
  • Ensure laboratory and shift operations are conducted in compliance with safety guidelines, cGLPs, cGMPs, and other applicable regulatory requirements
  • Build, lead, coach, and develop a high-performing organization capable of supporting both startup execution and long-term commercial manufacturing operations
  • Implement effective digital tools for leading the organization
  • Partner cross-functionally with Manufacturing, Process Development, Quality Assurance, Facilities & Engineering, Supply Chain, and other site functions to support startup readiness, process performance, and ongoing manufacturing operations
  • Participate in regulatory agency inspections and support site licensure and inspection readiness activities
  • Establish and drive Lean principles across all areas of responsibility to improve operational performance, reliability, efficiency, and compliance
  • Establish departmental goals, organizational strategies, staffing models, and KPIs to ensure successful execution of business objectives and sustainable 24/7 operational support
  • Interface with senior management on significant matters requiring coordination across organizational units and exercise independent judgment in decision-making
  • Translate complex technical and operational data into actionable insights and apply strong scientific and leadership knowledge to meet business objectives
  • Identify process gaps, implement innovative solutions, and lead operational excellence initiatives within the Amgen global QC network to improve efficiency, productivity, compliance, and cost effectiveness

Requirements

  • High school diploma / GED and 12 years of Aseptic Manufacturing experience OR Associate’s degree and 10 years of Aseptic Manufacturing experience OR Bachelor’s degree and 8 years of Aseptic Manufacturing experience OR Master’s degree and 6 years of Aseptic Manufacturing experience OR Doctorate degree and 2 years of Aseptic Manufacturing experience
  • In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.

Nice to have

  • Experience working in a GMP pharmaceutical manufacturing environment with classified areas and applicable gowning requirements
  • Degree in Chemistry, Biochemistry, Analytical Chemistry, Chemical Engineering, or related scientific field. Advanced degree preferred
  • Experience with QC analytical chemistry operations, including method transfer, qualification, validation, and routine testing in support of commercial biologics manufacturing
  • Strong technical expertise in analytical method families including chromatography (HPLC/UPLC), capillary electrophoresis (CE), gel-based methods, and general chemistry techniques
  • Experience with laboratory startup activities, equipment qualification, and transitioning teams and systems from startup into commercial operations
  • Experience with analytical data trending, laboratory investigations, deviations, CAPAs, change controls, and regulatory documentation within a GMP environment
  • Experience supporting regulatory inspections and health authority interactions
  • Strong understanding of cGMPs, data integrity requirements, and quality systems applicable to pharmaceutical Quality Control laboratories
  • Strong written and verbal communication skills, including technical writing, data interpretation, and presentation of complex technical information to leadership and cross-functional teams
  • Demonstrated ability to work independently, lead cross-functional initiatives, manage multiple priorities, and develop high-performing teams in a fast-paced manufacturing environment
  • Experience establishing and driving Lean, continuous improvement, and operational excellence initiatives within a QC organization

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 where possible
Amgen - All Job Offers

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Sr. Manager Quality Control - Chemistry

8 matching positions

Sr Facility Technical Manager

The SrFacility Technical Manager is responsible for managing the quality effort ...
Location
Location
United States , Fridley
Salary
Salary:
110000.00 - 140000.00 USD / Year
hbfuller.com Logo
H.B. Fuller
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in chemistry, Chemical Engineering, or other related degree
  • Strong competence with SAP or similar ERP systems
  • Experience with quality management systems and “Best Practices”
  • Experience leading and supervising others, communicating effectively, and solving problems independently or as part of a team
  • Strong organizational skills and ability to meet deadlines
  • Experience with Microsoft Word and Excel
  • Ability to lift and carry up to 50 pounds
Job Responsibility
Job Responsibility
  • Become familiar with and execute productivity, yield, and quality enhancement techniques and adjustments to process equipment and formulations
  • Troubleshoot quality problems, document and address issues with timely corrective actions
  • Recommend process and formulation improvements to new and existing products
  • Assist in process design and development
  • Batch validation and troubleshooting with R&D Chemist and Production Operators, including batch sheet computations
  • Oversee management of rework per standard business practices guidelines
  • Act as the ISO management representative for the facility, leading improvement and management of ISO procedures and work instructions
  • Support safe manufacturing practices and assist in compliance with all applicable safety and environmental rules, regulations, and procedures
  • Experience with ISO 9001
  • Develop, lead, and implement a plant quality assurance plan to reduce COPQ by conducting gap analysis and using tools such as SPC, control charts, Pareto diagrams, and 8D
What we offer
What we offer
  • comprehensive benefits
  • incentive and recognitions programs
  • health & wellness benefits
  • 401K contributions
  • paid time off
  • paid holidays
  • Fulltime
Read More
Arrow Right
New

Sr Manager, Quality - Microbiology

At Baxter Healthcare Corporation, we are deeply committed to improving patient o...
Location
Location
United States , Cleveland
Salary
Salary:
136000.00 - 170000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • A BS degree or equivalent experience, preferably in Microbiology, Biology, Chemistry, or related scientific discipline or equivalent relevant experience and at least 30 semester hours of microbiology coursework. A graduate degree in Microbiology or related field is desirable
  • A minimum of 10 years of professional experience in pharmaceutical or regulatory microbiology environments including at least 5 years of people management or supervisory experience
  • In-depth knowledge of pharmaceutical microbiology principles, regulatory requirements, and applicable industry standards
  • Demonstrated ability to analyze complex problems, lead investigations and develop sound, data-driven conclusions
  • The ability to manage and supervise a team of employees
  • Proven leadership skills with the ability to effectively manage, engage and develop teams
  • Excellent written and verbal communication skills, with the ability to collaborate effectively across multiple functional areas
  • Strong change leadership capabilities and experience supporting enterprise-level initiatives
Job Responsibility
Job Responsibility
  • Provide overall direction and leadership for microbiology laboratory operations to ensure results consistently meet product quality, safety, and performance standards
  • Implement, maintain and continuously improve quality systems and procedures to ensure compliance with Baxter policies and regulatory requirements
  • Ensure full compliance with applicable regulations in the including FDA, USP and cGMP requirements within the microbiology laboratory
  • Serve as a primary quality microbiology liaison during regulatory inspections
  • lead preparation activities and develop effective, timely responses to regulatory observations
  • Lead and participate in internal and external supplier quality audits and assessments to identify compliance gaps, assess risk, and implement corrective action plans
  • Identify, prioritize and manage continuous improvement initiatives that enhance quality, reliability, efficiency and cost effectiveness
  • Develop, revise and implement laboratory procedures, methods and techniques to ensure alignment with current operational and regulatory standards
  • Ensure laboratory safety, cleanliness, and biosafety compliance in accordance with Good Laboratory Practices (GLP) and biosafety requirements
  • promote a strong safety culture
What we offer
What we offer
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • medical and dental coverage that start on day one
  • insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
  • 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
  • Flexible Spending Accounts
  • Fulltime
Read More
Arrow Right

Sr Chemist

The Senior Chemist serves as a technical leader within the laboratory, providing...
Location
Location
United States , Tyler
Salary
Salary:
Not provided
delekus.com Logo
Delek US
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 4 year / Bachelor's Degree (Required)
  • In lieu of the above education requirements, an equivalent combination of education and experience may be considered
  • Five (5) or more years laboratory experience in a refining or related industry
  • including advanced knowledge of instrumentation troubleshooting and repair
  • Advanced knowledge analyzing data
  • Statistical Quality Control and laboratory LIMS systems (Required)
  • Advanced knowledge of refinery laboratory instrumentation and ASTM/UOP methods
  • Leadership or mentoring experience preferred
  • Method development and technical writing preferred
  • No Licensure or Certification Required
Job Responsibility
Job Responsibility
  • Provides advanced analytical support for refinery operations, with scheduled and requested analysis, to maintain proper quality of unit products
  • Provides advanced analytical support for Process Engineering problem solving
  • Provides advanced analytical support for Supply and Distribution to control raw materials and ensure quality of finished products, including retaining samples for future analysis verification
  • Monitors and runs necessary standards to ensure the accuracy and reliability of the laboratory equipment
  • Provides advanced support to Economics and Planning for finished product compliance and reporting
  • Evaluates results against operational targets and recommends a course of action if out of compliance
  • Mentor, train, and provide technical guidance to Chemists and Laboratory Technicians
  • Conduct advanced troubleshooting and repair coordination for laboratory instruments and analytical methods
  • Develop or modify analytical methods for unknown or non-routine samples and interpret results to support operational decisions
  • Maintain laboratory Quality Control (QC) systems to ensure the integrity, accuracy, and reliability of analytical data
What we offer
What we offer
  • up to a 10% match on 401K on your hire start, with a vesting timeline of only one year
  • medical benefits that start on day one with a 30% premium rebate annually
  • access to the Calm app for FREE
  • annual incentives through performance management program
  • pay for performance culture
  • Fulltime
Read More
Arrow Right

Sr Chemist

The Chemist is responsible for conducting chemical and physical laboratory tests...
Location
Location
United States , Krotz Springs
Salary
Salary:
Not provided
delekus.com Logo
Delek US
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 4 year / Bachelor's Degree
  • Six (6) or more years laboratory experience in a refining or related industry
  • Advanced knowledge of instrumentation troubleshooting and repair
  • Advanced knowledge analyzing data, Statistical Quality Control and laboratory LIMS systems
  • Analysis
  • Lab Operations
  • Detail Oriented
  • Communication
  • Reporting
  • Relationship Management
Job Responsibility
Job Responsibility
  • Conducting chemical and physical laboratory tests using instrumental and wet techniques in making qualitative and quantitative analyses of solids, liquids and gaseous materials to ensure quality and regulatory standards are met for raw, in-process and finished petroleum materials
  • Support safe and reliable operations to the Lab and other areas of the refinery
  • Utilizes all lab equipment and material appropriately, maintaining a safe, clean, and orderly working environment by complying with safety and laboratory procedures, rules, and regulations
  • Communicates and accurately records results using LIMS software
  • Conducts advanced troubleshooting of methods and instrumentation malfunctions and devise resolution plan
  • Develops testing methods for unknown samples and draws conclusions from results to support Operations
  • Maintains QC systems for the Laboratory to ensure data quality
  • Provides advanced analytical support for refinery operations, with scheduled and requested analysis, to maintain proper quality of unit products
  • Provides advanced analytical support for Process Engineering problem solving
  • Provides advanced analytical support for Supply and Distribution to control raw materials and ensure quality of finished products, including retaining samples for future analysis verification
What we offer
What we offer
  • Up to a 10% match on 401K on hire start with a vesting timeline of only one year
  • Medical benefits that start on day one with a 30% premium rebate annually
  • Access to the Calm app for FREE
  • Performance management program with additional annual incentives
  • Fulltime
Read More
Arrow Right

Sr Quality Engineer

As directed by the Quality Engineering Leader, the Quality Engineer II or Sr Qua...
Location
Location
United States , San Diego
Salary
Salary:
38.00 - 41.00 USD / Hour
gomillenniumsoft.com Logo
MillenniumSoft Inc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum of 3-5 years of experience in Medical Device, Biotech or Pharma Industry
  • Must have Validation, Nonconformance and CAPA experience
  • BS Biological Sciences, Chemistry, Bio-tech engineering, Bio-engineering or related field
  • Strong verbal and written communication skills
  • ability to write technical documents
  • Knowledge of quality system methodologies
  • Statistical Analysis basic knowledge e.g Minitab or Excel
  • Strong knowledge of Design Control, Process Validation and Supplier Management
  • Strong understanding and knowledge on ISO 9001, ISO 14971 and/or ISO 13485 (Design Control, Supplier Management and Risk Management)
  • Hands on experience using Six Sigma methodology
Job Responsibility
Job Responsibility
  • Experience with addressing any internal quality issues and help team to resolve it in timely manner with production, quality, and regulatory compliance need
  • Part of MRB team to help team to create or drive quality notification to release the material
  • Experience performing equipment and process validation studies such as writing and/or reviewing protocol, report, data analysis and deviations for new, existing and site relocation activities
  • Have a working knowledge of medical device or biological equipment maintenance from Quality standpoint such as Preventive Maintenance, Calibration and Out Of Tolerance activity support to the site and equipment owners
  • Experience performing supplier qualification including Audits and surveys with quality/purchasing/planning team to complete the supplier risk classification and supplier approval list
  • Support Supplier Corrective Action and Investigation activity to represent the Customer side
  • Experience on CAPA(Corrective Action and Preventive Action) for internal and external complaints or Non conformance or continuous improvement activities
  • Fulltime
Read More
Arrow Right

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

Sr Manager, Supplier Food Safety and QA

Lead the end-to-end Food Safety and risk mitigation strategy for Suppliers (Own ...
Location
Location
United States , Grand Rapids
Salary
Salary:
Not provided
meijer.com Logo
Meijer
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in Food Science, Microbiology, Chemistry, Engineering, or related field (or equivalent experience)
  • 8+ years in Food & Beverage quality/food safety with significant supplier management and manufacturing exposure
  • plant-level quality leadership experience required
  • Strong working knowledge of FSMA/Preventive Controls/HACCP, GFSI benchmarked schemes (e.g., SQF, BRCGS)
  • Demonstrated capability in risk assessment, supplier auditing, statistical tools/SPC, change management, and leading complex cross functional projects
  • Excellent communication skills with the ability to influence at multiple levels and with external partners
Job Responsibility
Job Responsibility
  • Lead the end-to-end Food Safety and risk mitigation strategy for Suppliers
  • Build and own a risk-based supplier Food Safety strategy
  • Establish policies and standards based on science, industry best practices, emerging risks, regulatory requirements
  • Translate regulatory changes and emerging risks into clear, prioritized controls, SOPs, and verification plans
  • Determine supplier compliance with applicable regulations
  • Support implementation of department processes, standards, policies, and projects
  • Build the program to establish, implement, and manage the Meijer Supplier Food Safety Standard
  • Lead standard development, risk model development, determine the risk ranking requirements, qualification, approval, and maintenance audits of supplier facilities
  • oversee corrective and preventive actions (CAPA) and escalation pathways
  • Integrate food safety requirements for product and process controls within the Own Brand product specifications
What we offer
What we offer
  • Weekly pay
  • Scheduling flexibility
  • Paid parental leave
  • Paid education assistance
  • Team member discount
  • Development programs for advancement and career growth
Read More
Arrow Right

Sr Associate, Manufacturing Regulatory

The Sr Associate, Manufacturing Regulatory Affairs is responsible for supporting...
Location
Location
Italy , Pomezia
Salary
Salary:
Not provided
it.alfasigma.com Logo
Alfasigma
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Degree in Pharmaceutical Chemistry and Technology (CTF), Chemistry, or Industrial Chemistry
  • A Master's degree in Regulatory Affairs is considered a strong asset
  • 1–2 years of experience in Regulatory Affairs within pharmaceutical companies, preferably in an international environment
  • Fluent in English (written and spoken)
  • Good proficiency with standard IT tools and basic statistical analysis
  • Strong attention to detail and quality-oriented mindset
  • Proactive, results-driven approach with the ability to manage assigned responsibilities independently
  • Excellent communication and interpersonal skills
  • Ability to work effectively in cross-functional teams
Job Responsibility
Job Responsibility
  • Assess regulatory impact of changes related to manufacturing sites, processes, and products
  • Plan and support activities associated with CMC (Chemistry, Manufacturing & Controls) variations and manufacturing site changes
  • Coordinate the collection, review, and organization of GMP documentation required for regulatory submissions
  • Draft and review documentation supporting CMC variations and manufacturing changes
  • Prepare product-specific regulatory declarations and contribute to Product Quality Reviews (PQRs)
  • Collaborate cross-functionally with Quality, Manufacturing, and other relevant departments to ensure alignment on regulatory strategies and timelines
  • Support continuous improvement initiatives to ensure ongoing compliance with regulatory standards
What we offer
What we offer
  • competitive salary
  • comprehensive benefits
  • extensive opportunities for professional growth and development
  • Fulltime
Read More
Arrow Right