Process Development Associate- Attribute Sciences

Amgen; Thousand Oaks (CA); Hybrid; USD 75,000 - 101,000; Full time

Job summary

Amgen Inc. in Thousand Oaks, CA is seeking a Process Development Associate in the Attribute Sciences group to support protein characterization using HPLC, UPLC, CE, and MS.

The role includes method development and qualification, data interpretation, and transferring methods to Quality Control while maintaining GMP practices and regulatory readiness.

Qualifications

• Bachelor’s degree in a scientific field or equivalent.
• Experience with HPLC/UPLC/MS preferred.
• Knowledge of GMP environment and regulatory expectations.

Responsibilities

• Perform method development and qualification studies using HPLC, UPLC, and Capillary Electrophoresis.
• Conduct LC-MS based characterization including intact mass and peptide mapping.
• Author results in notebooks and transfer qualified methods to QC.
• Coordinate studies supporting regulatory filings and comparability assessments.
• Collaborate with PD and QC teams to optimize analytical workflows.

Skills

Analytical chemistry

Team collaboration

Scientific documentation

Education

Bachelor’s degree in Chemistry/Biochemistry/Analytical Chemistry

Tools

HPLC

UPLC

Capillary Electrophoresis

MS

Job description

**Process Development Associate- Attribute Sciences**## **What you will do**Let’s do this. Let’s change the world. Amgen is a leading biotechnology company with a mission to serve patients around the world. As a science-based, patient-focused organization, we discover and develop innovative therapies to treat serious illnesses.Amgen’s Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces and optimizes innovative analytical tools to guide that development. The Pivotal PD organizations focus is developing and commercializing robust manufacturing processes across a wide range of therapeutic biologic modalities, including (but not limited to) monoclonal and bispecific antibodies, bispecific T-cell engagers (“BiTEs”), live oncolytic viruses, and synthetic medicines.As a PD Associate, the candidate will participate in protein characterization studies to support regulatory filings using High Performance Liquid Chromatography (HPLC) / Ultra Performance Liquid Chromatography (UPLC) and mass spectrometry (MS). The candidate will also work to develop, qualify, and transfer analytical methods to Quality Control, and optimize and troubleshoot existing methods.They will collaborate with other process development departments to support commercial process development and process characterization studies in support of marketing applications.This position is located at our Thousand Oaks, CA site. **Key responsibilities:** • Perform method development and qualification studies using HPLC, UPLC, and Capillary Electrophoresis platforms• Perform chromatographic fractionation, peptide mapping, intact mass, and other 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• With a 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## ## **What we expect of you**We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.**Basic Qualifications:**Bachelor’s degree OR Associate’s degree and 2 years of Scientific experience OR High school diploma / GED and 4 years of Scientific experience**Preferred Qualifications:*** Scientific background in method development and product characterization for therapeutic proteins* Preferred Degree in Biochemistry, Analytical Chemistry, Protein Chemistry or related subject area* Excellent written and verbal communication skills, ability to multitask, efficiently plan and follow through on complex projects* A self-starter, and someone who values working in teams## **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.In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:* 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. Refer to the Work Location Type in the job posting to see if this applies.## Apply now and make a lasting impact with the Amgen team.## **careers.amgen.com**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 does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.## ## SponsorshipSponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.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..**Salary Range**74,503.35USD -100,798.65 USD