Process Development Sr Principal Scientist

BioSpace; Thousand Oaks (CA); On-site; USD 170,000 - 210,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical, dental, and vision coverage

Flexible work models

Job summary

Amgen is seeking a senior Process Development Sr Principal Scientist in Thousand Oaks, CA. You will lead analytical method development and provide strategic leadership to advance late-phase programs through commercialization.

You will mentor a team of analysts, collaborate across PD, Manufacturing, Quality, and Regulatory, and help define analytical control strategies for product and process understanding. Excellent communication and writing are essential.

Qualifications

• Experience in analytical method transfer and validation.
• Strong cross-functional collaboration.
• Experience with oligonucleotide or small molecule analytics.
• Excellent technical writing skills.

Responsibilities

• Lead analytical method development for late-phase programs.
• Mentor analysts and lead ASTL team.
• Collaborate with PD, Manufacturing, QA, Regulatory.
• Prepare regulatory CMC sections and address inquiries.

Skills

Excellent communication

Cross-functional teamwork

Analytical thinking

Technical writing

Education

PhD in Analytical Chemistry

PharmD

MD

MS degree

Bachelors degree

Tools

Mass spectrometry (MS)

UV spectroscopy

NMR

FTIR

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 Sr Principal Scientist

What you will do

In this vital role, you will lead a team of analytical scientists responsible for developing, transferring, validating, and implementing analytical methods to support late-phase oligonucleotide programs through commercialization. As the Attribute Sciences Team Lead (ASTL), you will provide scientific, technical, and strategic leadership, driving the development and application of analytical tools to characterize critical quality attributes and advance product and process understanding. You will leverage platform expertise and deep product attribute knowledge to shape analytical control strategies and enable successful process performance qualification (PPQ), regulatory submissions, marketing authorization, and commercial launch. In close collaboration with Process Development, Manufacturing, Quality, Regulatory, and external partners, you will influence cross-functional decisions, resolve complex technical challenges, and ensure successful execution of commercialization strategies.

Lead and mentor a group of analysts in supporting process development. Provide career development guidance to the team members.

Lead analytical method development for synthetic small molecules, synthetic peptide, and/or SiRNA manufacturing, release testing and characterization.

Collaborate closely with drug substance and drug product process development colleagues to achieve project objectives.

Define analytical control strategies and implement methodologies for development of late phase clinical programs.

Provide concise summary to cross-functional leadership for endorsement of key decisions.

Oversee activities at contract manufacturing and testing sites.

Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Address analytical and product quality inquiries from health authorities.

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.

Basic Qualifications

• Doctorate degree PhD OR PharmD OR MD and 2 years of Scientific experience
• OR
• Masters degree and 5 years of Scientific experience
• OR
• Bachelors degree and 7 years of Scientific experience

Preferred Qualifications

• PhD in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Material Sciences, Pharmaceutical Sciences, or related discipline.
• Experience in the pharmaceutical or biotech industry, focusing on process and product development, and analytical method development for small molecule, peptide, and/or oligonucleotide drug substances and products.
• Strong understanding of small molecule analysis, structure elucidation and solid-state characterization informed by knowledge of organic chemistry.
• Strong understanding of peptide and/or oligonucleotide structural elucidation and characteristics that relate to quality of peptide and/or oligonucleotide.
• Hands on experience in method development, validation, and transfer for in-process, release, and stability testing
• Strong experience in oligonucleotide method development, characterization, and analytical control strategy especially having mass spectroscopy (MS) experience.
• Proficiency in a broad spectrum of structure elucidation and physicochemical techniques including MS, UV, NMR, FTIR, etc.
• Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, etc.
• Solid understanding of GLP and GMP requirements and their application in a phase appropriate manner
• Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, able to manage deliverables against timelines.
• Excellent communication skills and ability to provide concise summary to cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile
• Ability to work effectively in cross-functional teams, and across various geographic locations in different time zones.
• Excellent technical writing skills with attention to detail in authoring methods, specifications, technical reports, and regulatory filing documents

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.

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.

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.

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.