Biochemistry Production Operator Job at Diasorin (Saluggia)

Manager Quality Control - HPLC Labs

Lead the HPLC Labs during the 2nd shift —ensuring compliant, accurate testing an...

Location

United States , Juncos

Salary:

Not provided

Amgen

Expiration Date

Until further notice

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

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

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

New

Biochemist I

The Biochemist I will work independently in a laboratory setting, performing tas...

Location

United States , San Diego

Salary:

Not provided

MillenniumSoft Inc

Expiration Date

Until further notice

Requirements

Previous experience in laboratory work or biochemistry-related tasks
Familiarity with conjugation techniques and laboratory equipment operations is preferred
Strong understanding of laboratory processes and chemistry principles
Attention to detail and consistency in techniques and documentation
Ability to prioritize tasks and meet deadlines
Proficient in problem-solving and addressing issues independently
Teamwork and collaboration skills
Bachelor’s degree in Biochemistry or a related field
Knowledge of laboratory safety practices and Environmental Health & Safety guidelines
Ability to follow instructions and complete tasks with minimal supervision

Job Responsibility

Perform various conjugation processes independently, understanding the techniques, theories, and chemistry involved
Ensure accuracy and consistency in laboratory techniques, documentation, data entry, labeling, and meeting production specifications
Review and resolve issues in batch records and other documents to minimize business impact
Follow departmental guidelines and promote a safe work environment, addressing hazards and participating in Environmental Health & Safety (EH&S) programs
Assist with lab supply orders, reagent preparations, equipment maintenance, and other assigned duties
Complete assignments within deadlines to maintain productivity

Fulltime

Specialist Manufacturing: NPI, Process Owner

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...

Location

United States , Holly Springs

Salary:

114990.00 - 139433.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED & 10 years of biotechnology operations experience
Associate’s degree & 8 years of biotechnology operations experience
Bachelor’s degree and 4 years of biotechnology operations experience
Master’s degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience
Doctorate degree
Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
Excellent cross-functional project management, meeting facilitation, and technical writing skills
Experience in Downstream GMP manufacturing operations
Strong technical knowledge of drug substance processing (harvest, chromatography, filtration, buffer preparation) and a broad understanding of related disciplinary areas in bioprocessing
Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.

Job Responsibility

Communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups
Ensure new products are successfully introduced into ANC’s biologics manufacturing facility and ownership of downstream unit operations
Host cross-functional meetings to drive to timelines to support the tech transfer of the program into the facility as well as process ownership for some downstream process unit operations
New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, as well as Quality to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools (i.e. Smartsheet)
Downstream biologics drug substance technical expert who leads or participates in projects, including aiding in commissioning and qualification and training staff on equipment and processes
Support Manufacturing in troubleshooting, problem solving and RCAs
Support CAPA development to prevent error recurrence
Owns New Product Introduction Change Controls and collaborates with stakeholders to drive on-time completion
Responds to regulatory questions and/or audit findings
Ensures that manufacturing production documents (e.g. Standard Operating Procedures) are accurate and up to date

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Specialist Manufacturing: NPI, Upstream Process Owner

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...

Location

United States , Holly Springs

Salary:

114990.00 - 139433.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED & 10 years of biotechnology operations experience
Associate’s degree & 8 years of biotechnology operations experience
Bachelor’s degree and 4 years of biotechnology operations experience
Master’s degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience
Doctorate degree
Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
Excellent cross-functional project management, meeting facilitation, and technical writing skills
Experience in Upstream GMP manufacturing operations
Strong technical knowledge of Upstream drug substance processing (media preparation, cell culture, harvest) and a broad understanding of related disciplinary areas in bioprocessing
Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.

Job Responsibility

Communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups
Ensure new products are successfully introduced into ANC’s biologics manufacturing facility and ownership of upstream unit operations
Host cross-functional meetings to drive to timelines to support the tech transfer of the program into the facility as well as process ownership for some upstream process unit operations
New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, as well as Quality to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools (i.e. Smartsheet)
Upstream biologics drug substance technical expert who leads or participates in projects, including aiding in commissioning and qualification and training staff on equipment and processes
Support Manufacturing in troubleshooting, problem solving and RCAs
Support CAPA development to prevent error recurrence
Owns New Product Introduction Change Controls and collaborates with stakeholders to drive on-time completion
Responds to regulatory questions and/or audit findings
Ensures that manufacturing production documents (e.g. Standard Operating Procedures) are accurate and up to date

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Principal Scientist – Sterility Assurance

The Principal Scientist – Sterility Assurance within Technical Services / Manufa...

Location

United States , Durham

Salary:

65.00 USD / Hour

Medasource

Expiration Date

Until further notice

Requirements

BS or MS in Microbiology, Biology, Biochemistry, Chemical/Biochemical Engineering, or related scientific discipline
Experience with parenteral drug product manufacturing in a cGMP environment
Experience supporting cGMP operations in areas such as environmental monitoring, sterility assurance validation, contamination control, technical services/MSAT, microbiology laboratory, or quality assurance

Job Responsibility

Provide technical guidance and oversight of aseptic processing activities to operational Process Teams
Support or lead investigations related to sterility assurance, including root cause analysis and remediation
Perform scientific and risk-based evaluations of aseptic processes, environmental monitoring, disinfectant efficacy studies, sanitization programs, and contamination control strategies
Support start-up and tech transfer activities related to sterile manufacturing operations
Analyze microbial, manufacturing, and environmental monitoring data using statistical principles to identify trends, process disruptions, and improvement opportunities
Conduct periodic review of EM program performance and recommend enhancements to ensure a state of control
Use risk management tools to evaluate proposed processes and associated controls for microbial, particulate, and endotoxin risk
Create, execute, review, and/or approve technical documents, including protocols, reports, procedures, and change controls
Support internal and external audits by providing subject-matter expertise in sterile manufacturing, environmental monitoring, and contamination control
Participate in continuous improvement projects aimed at strengthening quality systems and sterility assurance programs

What we offer

Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs
We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays
We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc

Undergrad Co-op - Quality, Manufacturing, Operations and/or Engineering

Join Amgen’s Mission of Serving Patients. We are offering multiple co-op opportu...

Location

United States , Juncos

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Currently enrolled in a Bachelor’s Degree program at an accredited college or university with a minimum 3.00 GPA
Pursuing or have completed at least 3 years of study in Biomedical, Industrial, Mechanical, Chemical, Electrical, Software, Computer Engineering, or Life Sciences (Chemistry, Biology, Microbiology, Biotechnology, Biochemistry)
Must be enrolled in a Bachelor’s degree program following the potential internship or co-op assignment

Job Responsibility

Measure and analyze current system and process performance
Drive improvements in operational efficiency and productivity across the organization, maximizing AI and other technology tools
Actively learn through on-the-job training to empower you to gain practical experience, develop new skills, and apply knowledge in real-world settings
Identify and implement new processes across departments and functions
Support the maintenance of detailed project plans and process performance metrics
Participate in and lead continuous improvement initiatives
Prepare project justifications and proposals

What we offer

Build a network of colleagues that will endure and grow throughout your time with us and beyond
Bring your authentic self to the table and become the professional you’re inspired to be through accepting a culture that values the diversity of thought and experience and will flex to your strengths and possibilities
Participate in executive and social networking events, team building activities, workshops, and more

Sterility Assurance Scientist

This technical role is responsible for developing and implementing the site’s st...

Location

United States , Concord

Salary:

35.00 USD / Hour

Medasource

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
Demonstrated understanding and experience with scientific principles for manufacturing parenteral drug products under cGMP conditions, including operations, microbiology, environmental monitoring, sterility assurance, validation, technical services, and/or quality assurance
2+ years (Senior) or 5+ years (Principal) pharmaceutical manufacturing experience in microbiology, sterility assurance, TSMS, or related departments
Technical expertise in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, cleaning/sanitization strategies, and disinfectant efficacy
Knowledge of microbiological media, enumeration techniques, and microorganism isolation and identification (Principal level)
Strong interpersonal, organizational, oral, and written communication skills for cross-functional teamwork and technical documentation
Experience with data analysis, trending, and root cause investigations related to sterility assurance programs
Ability to wear appropriate PPE and gown into cleanroom attire as required for manufacturing or laboratory environments
Flexibility to support varying production schedules, including occasional extended or off-hour work and travel for training and implementation
Ability to perform tasks requiring repetitive motion, standing or walking for long periods

Job Responsibility

Develop and implement sterility assurance programs and contamination control strategies for the site
Provide technical guidance and oversight for environmental monitoring, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization activities, including disinfectant efficacy
Lead or support technical activities related to airflow pattern testing, environmental monitoring performance qualifications (EM PQ), aseptic processing techniques, and facility monitoring
Author, execute, review, and approve technical documents, protocols, and change controls related to sterility assurance programs
Analyze microbial and manufacturing data to identify trends, process discrepancies, and opportunities for continuous improvement
Apply sterility assurance risk management to evaluate manufacturing processes and associated controls for potential microbial, endotoxin, and particulate contamination
Lead or support root cause investigations and corrective actions for sterility assurance issues
Participate in and provide technical support during internal and external audits
Mentor team members and collaborate with cross-functional teams to achieve business and quality objectives
Support the development and maintenance of cleanroom gowning and aseptic technique strategies/programs

What we offer

Competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs
401k plan that includes a company match and is fully vested after you become eligible
Paid time off, sick time, and paid company holidays
Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.

New

Scientist 2, Biology

The Life Science Innovation group at BD Technologies and Innovation (BDTI) is se...

Location

United States , Research Triangle Park

Salary:

28.00 - 32.00 USD / Hour

MillenniumSoft Inc

Expiration Date

Until further notice

Requirements

B.A./B.S. in Chemistry, Biology, Biochemistry, Microbiology, Biotechnology, or related field
Minimum of 2 years of relevant academic, clinical, or industry lab work required
Learning agility and timely execution of tasks is required

Job Responsibility

Execution of molecular biology methods including DNA quantitation and characterization (Electrophoresis, Nanodrop, Qubit, etc) DNA extraction and purification, qPCR, and isothermal nucleic acid amplification
Apply good laboratory practice and analytical skills to support meticulous reagent and consumable inventory tracking
Work with other team members to resolve technical challenges during assay development
Maintains familiarity of molecular diagnostics methodologies and demonstrate this knowledge within responsibility areas
Provides technical input based on experience to colleagues and provides support to other functional groups
Supports the development and/or adaptation of relevant Standard Operating Procedures (SOPs)
May assist with product quality investigations
Performing molecular assay work primarily focused on isothermal nucleic acid amplification
Analyze and interpret results to guide experimental design with minimal oversight

Fulltime

Biochemistry Production Operator

Diasorin

Location:
Italy , Saluggia

Category:
Manufacturing

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 11, 2026

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