Process Development Principal Scientist

Biopharma Careers; Thousand Oaks (CA); On-site; USD 141,000 - 192,000; Full time

Job summary

Amgen is seeking a Process Development Principal Scientist to lead manufacturing process development and analytical strategy for biotherapeutics. You will guide cross-functional teams, design experiments to improve efficiency and quality, and Advance regulatory-compliant documentation.

The role requires deep protein biochemistry knowledge, leadership, and expertise in analytical methods such as HPLC/UPLC, CE, and mass spectrometry.

Qualifications

• - Doctorate or equivalent with relevant industry experience.
• - Strong leadership and collaborative skills.
• - Expertise in analytical methods for protein therapeutics.

Responsibilities

• Head research and development efforts related to manufacturing processes.
• Lead analytical assessment of Pre-pivotal biotherapeutic through development.
• Design experiments to understand protein attributes and stability.
• Apply analytical expertise to characterize therapeutics using CE, SEC, IEX, RP, HILIC, and MS.
• Evaluate method performance and regulatory documentation.
• Support drug substance/product development and technology transfer.

Skills

Analytical chemistry

Protein biochemistry

Leadership

Communication

Independent work

Education

PhD/PharmD/MD with 2+ years

MS with 5+ years

BS with 7+ years

Tools

HPLC/UPLC

CE

Mass spectrometry

Job description

Career Category

Operations

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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 Principal Scientist

What you will do

• Let’s do this. Let’s change the world. In this vital role you will head the research and development efforts related to manufacturing processes. They design, conduct, and interpret experimental studies and develop novel methodologies to improve efficiency and quality.
• Serves as the Attribute Sciences Representative on cross-functional project teams and collaborates effectively with scientists across multidisciplinary teams.
• Leads and drives the analytical assessment of a Pre-pivotal candidate biotherapeutic through development.
• Designs experiments to build a fundamental understanding of therapeutic protein attributes and stability characteristics.
• Applies advanced technical expertise in analytical methods to characterize protein therapeutics, including CE, SEC, IEX, RP, HILIC, and mass spectrometry, with strong understanding of the theoretical and practical aspects of stability-indicating assays, including design, performance, and data interpretation.
• Evaluates analytical method performance and reliability, including the impact of proposed method changes.
• Demonstrates deep understanding of product quality attributes, analytical approaches used to measure them, and strategies to ensure appropriate control.
• Supports drug substance and drug product process development, protein characterization, analytical data generation for regulatory submissions, and technology transfer activities.
• Authors regulatory documents and applies understanding of regulatory expectations for analytical methods, control strategies, stability strategies, and comparability.
• Stays current in the field and evaluates emerging analytical technologies.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.

• Doctorate degree PhD OR PharmD OR MD and 2 years of Scientific experience
• OR
• Master’s degree and 5 years of Scientific experience
• OR
• Bachelor’s degree and 7 years of Scientific experience

• Ph.D. in biochemistry, analytical chemistry, biophysics, pharmaceutical chemistry or a related life science field, with 2 years of industry experience.
• Strong leadership skills and ability to communicate in a team environment succinctly and effectively.
• Deeply critical thinking with a creative and problem-solving mindset.
• Highly knowledgeable in protein biochemistry and protein-based biotherapeutics.
• Strong expertise in developing, qualifying, and troubleshooting analytical methods using HPLC/UPLC, CE, mass spectrometry, and related technologies to characterize protein therapeutics.
• Strong laboratory skills, including experimental design and execution, complex data interpretation, and timely delivery of results.
• Familiarity with common biotherapeutic critical quality attributes, such as aggregation, fragmentation, deamidation, oxidation, and partial reduction, as well as tools used for their characterization and quantification.
• Ability to work independently to advance projects and studies within required timelines.
• Excellent written and verbal communication skills, with the ability to document, present, and discuss scientific results in a fast-paced, multidisciplinary environment.

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.

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 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

141,836.95USD -191,897.05USD