Process Development Senior Scientist - Attribute Sciences

Initial Therapeutics, Inc.; Cambridge (MA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Stock-based long-term incentives

Retirement and Savings Plan

Award-winning time-off plans

Flexible work models

Job summary

Amgen is seeking a Process Development Senior Scientist in Cambridge, MA to join the Biologics Pivotal Attribute Sciences team. You will develop and transfer analytical methods, lead protein characterization, and drive automation-ready workflows while supporting regulatory submissions for INDs/BLAs.

The role emphasizes cross-functional collaboration and data-driven decision making. Ideal candidates have a doctorate with strong analytical biology expertise, and experience in chromatographic and

Qualifications

• PhD or equivalent required with strong analytical biology background.
• Experience in analytical method development for biologics and CMC support.
• Ability to author/regulatory submissions for INDs/BLAs.

Responsibilities

• Develop, optimize, and transfer analytical methods for CQAs and process characterization.
• Lead late-stage protein characterization and mass spectrometry analyses.
• Create robust, automation-ready workflows to improve lab efficiency.
• Interpret complex data and draft technical/regulatory documents for INDs/BLAs.
• Provide SME guidance to cross-functional partners.

Skills

Analytical method development

LC/MS expertise

Data interpretation

Cross-functional guidance

Regulatory documentation

Education

Doctorate degree

Master's with 2 years scientific experience

Bachelor's with 4 years scientific experience

Tools

Thermo Orbitrap platforms

Chromeleon

Biopharma Finder

Laboratory automation software

Job description

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. 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, 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 Senior Scientist Attribute Sciences

What you will do

Lets do this. Lets change the world.This is an exciting opportunity to join the Amgen Biologics Pivotal Attribute Sciences team based in Cambridge, Massachusetts. In this role you will:

• Develop, optimize, troubleshoot, qualify, validate, and transfer analytical methods for monitoring critical quality attributes and supporting process characterization, comparability assessments, investigations, and control-strategy development.


• Lead late-stage protein characterization, structural elucidation, and forced degradation studies using high-resolution LC/MS, including peptide mapping, disulfide mapping, and intact mass analysis.


• Establish robust, automation-ready analytical workflows encompassing sample preparation, instrument integration, data processing, and report generation to reduce hands-on time and increase lab efficiency.


• Interpret complex analytical data and author or review technical and regulatory documentation, including analytical methods, protocols, reports, and CMC sections for INDs and BLAs.


• Provide analytical subject-matter expertise and technical guidance to cross-functional partners.

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 leder with these qualifications.

Basic Qualifications:

Doctorate degree
OR
Masters degree and 2 years of Scientific experience
OR
Bachelors degree and 4 years of Scientific experience

Preferred Qualifications:

• Three or more years of experience in pharmaceutical process development with related experience in analytical support, execution of methods, and investigational testing.


• Deep expertise in analytical method development, as well as structural and physicochemical characterization of biologics, including monoclonal antibodies, fusion proteins, and protein conjugates such as antibody-drug conjugates.


• Deep LC/MS expertise in bottom-up peptide mapping (including disulfide mapping) and intact mass analysis for biologics, with strong fundamentals in sample preparation, artifact control, and MS/MS data interpretation.


• Hands-on experience with Thermo Orbitrap platforms, including routine maintenance, calibration, and independent troubleshooting of common failure modes. Experience with Chromeleon and Biopharma Finder is a plus.


• Hands-on experience with laboratory automation including liquid handlers, pipetting robots, and automation software.


• Experience in authoring and reviewing regulatory submissions, especially module 3 (Quality) common technical documents for IND/BLA submissions.


• Strong written and verbal communication skills, with the ability to translate complex data into clear recommendations for diverse internal and external stakeholders.


• A proactive self-starter with strong problem-solving and decision-making skills who works independently, prioritizes effectively, and manages multiple complex projects through completion.

What you can expect from 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.

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.

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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.