Sr Associate Quality Control

Amgen Inc.; Dublin; Presencial; EUR 53 000 - 71 000; Tempo integral

Resumo da oferta

Amgen Inc. is seeking a QC Senior Associate for the QC Bioanalytical Sciences laboratory at the Amgen Manufacturing site. You will lead, coordinate, and support lab operations and compliance with minimal supervision, driving continuous improvement and Right First Time (RFT).

The role represents QC with internal and external customers and may include additional duties as required. You will work with Cell-Based Potency Bioassays, Immunoassays, and Cell Culture, plan complex methods, review data,

Qualificações

• Hold a third level qualification (Degree) in Biology, Biotechnology or related discipline.
• Have 4-5 years of experience in a pharmaceutical/healthcare Laboratory.
• Strong background in Cell-Based Potency Bioassays, Immunoassays and Cell Culture is essential.
• Excellent written and verbal communication skills.
• Experience leading cross-functional teams.
• Knowledge of applicable Regulatory requirements.
• Experience working with Regulatory inspections and interaction with inspectors is preferable.

Responsabilidades

• Experience in a wide variety of analytical techniques including but not limited to Cell-Based Potency Bioassays, Immunoassays, Cell Culture and Aseptic Technique.
• Plan and perform multiple, complex routine/non-routine methods and procedures and a large variety of assays.
• Participate in the peer review of analytical data.
• Responsible for providing technical guidance and applying expertise and critical thinking to help to resolve technical issues.
• Lead training of staff on technical aspects of job as required.
• Develop, revise and implement procedures that comply with appropriate regulatory requirements.
• Qualification of analytical equipment and related testing functions.
• Participate in Analytical Method Transfers Compliance with SOPs and Registered specifications.
• Ensure the laboratory is operated in a safe manner.
• Maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP.
• Ensure timely completion of Laboratory Investigations and Deviations.

Conhecimentos

Excellent written and verbal\n-?

Experience leading cross-functional\n-

Problem solving methods

Planning/organisation

Teamwork and collaboration

Coaching and motivating

Formação académica

Bachelor's degree in Biology, Biotechnology or related discipline

Ferramentas

Regulatory knowledge tools

Descrição da oferta de emprego

Career Category Quality Job Description Join Amgen’s Mission of Serving Patients 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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer.

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.

Overview

This job specification outlines the general responsibilities associated with the role of QC Senior Associate for the QC Bioanalytical Sciences laboratory on the Amgen Manufacturing site. This role will be responsible for leading, coordinating, facilitating, and undertaking activities pertaining to lab operations and compliance, with minimal supervision, acting as a role model for other lab colleagues. The role undertakes implementing continuous improvement projects and supporting a lean culture and Right First Time (RFT). The role also represents the QC unit by liaising with internal and external customers. Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with their role.

Key Responsibilities

Experience in a wide variety of analytical techniques including but not limited to Cell-Based Potency Bioassays, Immunoassays, Cell Culture and Aseptic Technique. Experience with liquid-handling robots is also preferable.

Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.

Participate in the peer review of analytical data.

Responsible for providing technical guidance and applying expertise and critical thinking to help to resolve technical issues.

Lead training of staff on technical aspects of job as required.

Develop, revise and implement procedures that comply with appropriate regulatory requirements.

Qualification of analytical equipment and related testing functions.

Participate in Analytical Method Transfers Compliance with Standard Operating Procedures and Registered specifications.

Ensure the laboratory is operated in a safe manner.

Maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP.

Ensure timely completion of Laboratory Investigations and Deviations.

Participate in the generation and update of SOP’s, trend data, investigations, Deviations, validation protocols, reports, method validation/verifications and equipment qualifications.

Participate in regulatory agency inspections as required.

Plan and implement procedures and systems to maximise operating efficiency.

Manage and contribute to the achievements of department productivity and quality goals.

Qualifications

Excellent written and verbal communication skills.

Knowledge of applicable Regulatory requirements.

Experience with Regulatory inspections and interaction with inspectors is preferable.

Experience leading cross-functional teams.

Experience working with teams and influencing decision.

Skilled in the use of problem-solving tools/techniques.

Knowledge and Experience: Hold a third level qualification (Degree) in Biology, Biotechnology or related discipline.

Have 4-5 years of experience in a pharmaceutical/healthcare Laboratory.

Strong background in Cell-Based Potency Bioassays, Immunoassays and Cell Culture is essential.

Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Salary Range

52,756.95 EUR - 71,377.05 EUR

Equal Opportunity

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

About Amgen

Amgen is a biotechnology pioneer since 1980, growing to one of the world’s leading independent biotechnology companies. It has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen