Process Development Sr Associate

Amgen; Thousand Oaks (CA); Híbrido; USD 91 000 - 108 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Stock options

Retirement plan

Medical insurance

Life insurance

Disability insurance

Annual bonus

Sales incentive programs

Flexible work models (remote/ hybrid)

Resumo da oferta

Amgen's Process Development team in Thousand Oaks seeks a Process Development Associate to perform method development and qualification using HPLC, UHPLC, CE, and LC-MS to support product characterization and comparability studies.

You will document results, transfer methods with QA, help maintain GMP environment, and collaborate across teams on process development, characterization, and validation to support marketing applications.

Qualificações

• Bachelor’s degree in Chemistry or related field with 2+ years of relevant experience.
• Analytical chemistry experience for protein molecules and degradation studies.
• Experience with HPLC/LC-MS/CE and instrument troubleshooting.
• Ability to design, execute and transfer analytical methods with data analysis.
• GLP environment experience and accurate lab notebook documentation.

Responsabilidades

• Perform method development and qualification studies using HPLC, UHPLC, and CE.
• Conduct LC-MS studies to support protein characterization and comparability.
• Document results in notebooks and transfer through QA to operations.
• Maintain Attribute Sciences instruments and GMP-compliant environment.
• Evaluate quality attributes and perform attribute identification and characterization.
• Coordinate accelerated stability studies and define degradative pathways.
• Explore novel analytical technologies to drive innovation.
• Address questions from health authorities through experiments and analyses.
• Collaborate with partner organizations during process development, characterization, and validation.

Conhecimentos

Analytical chemistry for proteins

Data analysis

GLP knowledge

Documentation in notebooks

Formação académica

Bachelor’s degree in Chemistry, Chemical Biology or related field

Ferramentas

HPLC/UHPLC

Capillary Electrophoresis (CE)

LC-MS

Empower

Chromeleon

ChemStation

Waters instruments

Agilent instruments

Maurice software

Descrição da oferta de emprego

Career Category Process Development 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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. 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.

Process Development Associate Duties

• Perform method development and qualification studies using High Performance Liquid Chromatography (HPLC), Ultra-High Performance Liquid Chromatography (UHPLC), and Capillary Electrophoresis (CE) platforms;
• Perform chromatographic fractionation, peptide mapping, intact mass, and other Liquid Chromatography – Mass Spectrometry (LC-MS) studies to support product characterization and comparability studies;
• Author results in laboratory notebooks and method development reports, interfacing closely with Attribute Sciences Team Leads and Quality Control to transfer and troubleshoot qualified methods;
• Participate in the maintenance of Attribute Sciences instruments and assist the Attribute Sciences department in maintaining a phase-appropriate good manufacturing practices (GMP) environment;
• Focus toward evaluation of critical quality attributes, coordinate and perform attribute identification and characterization studies, including isolation and analysis of chromatography fractions;
• Conduct and coordinate accelerated stability studies to define therapeutic degradative pathways;
• Perform evaluation of novel platform analytical technologies to help drive innovation;
• Perform experiments to help answer questions from health authorities;
• Collaborate with partner organizations during commercial process development, process characterization, and process validation studies to support marketing applications.

Requirements

• Bachelor’s degree (or foreign equivalent) in Chemistry, Chemical Biology or related field & 2 years of experience in the job offered or a research-related occupation. Position requires 2 years of experience in the following: Analytical chemistry experience for protein molecules, and completion of project deliverables including: designing and conducting degradation experiments, extracting and analyzing results via dedicated software: Empower, Chromeleon, and ChemStation;
• Liquid Chromatography principles, including the concepts of stationary and mobile phases, partitioning and separation based on different affinities;
• Analytical method development (chromatography and mass spectrometry), technologies and instrumentation including: High Performance Liquid Chromatography (HPLC), Liquid Chromatography – Mass Spectrometry (LC-MS), Solo Variable Pathlength Extension (SoloVPE), and Capillary Electrophoresis (CE);
• Method qualification and transfer for analytical instruments, along with data analysis and statistical evaluation of experimental results;
• Application analytical instrument troubleshooting across different platforms: Waters, Agilent, and Maurice;
• Analytical deliverables for pharmaceutical processes and product development;
• Data analysis, statistical analysis and method qualifications and transfers;
• Technical knowledge of proteins and peptides;
• Implementing Standard Operating Procedures in a laboratory environment in accordance with good laboratory practices (GLP) standards;
• Recording experimental conditions, results and observations in a laboratory notebook.

Job type

Full-Time position.

The annual salary range for this position in the U.S. is $91,125.00 - $108,296.00 per year.

Also, this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation.

For more details visit https://careers.amgen.com/life-at-amgen/benefits/

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

• 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, including remote and hybrid work arrangements, where possible
• Also, this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. 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. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen