Process Development Associate

BioSpace; Thousand Oaks (CA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Comprehensive benefits

Bonus program

Stock incentives

Time-off flexibility

Flexible work model

Job summary

Amgen in Thousand Oaks, CA is seeking a Process Development Associate to participate in protein characterization studies supporting regulatory filings using CE, HPLC/UPLC and MS. The PD team optimizes analytical methods and transfers them to Quality Control, enabling robust manufacturing processes.

You will collaborate across departments to support marketing applications, perform method development and qualification studies, and contribute to GMP-compliant operations in a fast-paced,

Qualifications

• Bachelors degree
• Associates degree and 2 years of Scientific experience
• High school diploma / GED and 4 years of Scientific experience

Responsibilities

• Perform method development and qualification studies using HPLC, UPLC, and CE 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 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

Education

Bachelors degree

Associates degree and 2 years of Scientific experience

High school diploma / GED and 4 years of Scientific experience

Job description

Basic Qualifications

Bachelors degree

Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Process Development Associate

What you will do

Lets do this. Lets 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.

Amgens 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), antibodydrug conjugates, live oncolytic viruses, and synthetic medicines.

As a PD Associate, the candidate will participate in protein characterization studies to support regulatory filings using Capillary Electrophoresis (CE), 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 CE 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

• Bachelors degree
• Associates degree and 2 years of Scientific experience
• 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, well 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

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.

Application deadline

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.

Sponsorship

Sponsorship 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 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. 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.