Process Development Principal Scientist

Initial Therapeutics, Inc.; Cambridge (MA); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Comprehensive employee benefits

Discretionary annual bonus program

Stock-based long-term incentives

Flexible work models

Job summary

Amgen is looking for a Process Development Principal Scientist in Cambridge, Massachusetts. In this role, you will lead analytical efforts in pivotal clinical process development, working closely with cross-functional teams to define control strategies for late phase clinical programs.

The ideal candidate will have a PhD and experience in analytical method development, small molecule analysis, and solid-state characterization. Join us to contribute your expertise to key drug development projects.

Qualifications

• Doctorate degree in relevant field and 3 years of experience.
• Masters degree with 6 years of scientific experience.
• Bachelors degree with 8 years of scientific experience.

Responsibilities

• Lead attribute and analytical aspects of pivotal clinical process development.
• Define analytical control strategies for development of late phase clinical programs.
• Author technical reports and CMC sections in regulatory documents.

Skills

Small molecule analysis

Analytical method development

Chromatographic techniques

Solid-state characterization

Good Laboratory Practices

Good Manufacturing Practices

Leadership

Technical writing

Education

Doctorate degree PhD, PharmD, or MD

Masters degree

Bachelors degree

Tools

Analytical Chemistry

Process Analytical Technologies

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

In this vital role you will join Amgen’s Attribute Sciences (AS) department within the Process Development (PD) organization. You will define the favorable quality characteristics of the therapies it produces and optimize state‑of‑the‑art analytical tools to guide that development. The Pivotal PD organization focuses on developing and commercializing robust manufacturing processes across a wide range of therapeutic modalities, including synthetic medicines (oligonucleotides and small molecules).

In this vital role as an Attribute Sciences team lead and group lead you will provide strategic analytical leadership to teams developing commercial manufacturing processes for synthetic and hybrid molecules and collaborate closely with Drug Substance, Drug Product, and Product Quality colleagues.

• Lead all attribute and analytical aspects of a program in pivotal clinical process development while working cross‑functionally within a Product development team
• Define analytical control strategies and implement methodologies for development of late phase clinical programs, including analytical method development and optimization
• Lead method transfer and support cGMP manufacturing activities at internal manufacturing, and contract manufacturing and testing sites
• Author technical reports and analytical Chemistry, Manufacturing, and Controls (CMC) sections in regulatory documents; answer analytical and product quality questions from health authorities
• Drive product characterization in support of process comparability studies, regulatory filings, regulatory questions, and reference standard qualification
• Provide expertise and evaluation of Amgen’s platform and analytical technologies, helping to drive innovation and efficiency within Process Development
• Help define strategies that improve the effectiveness and efficiency of the Attribute Sciences department
• Maintain current knowledge in the analytical development field, including literature and technology development for cutting‑edge and regulatory‑driven activities, and apply this knowledge to the evaluation and development of new methodologies
• Serve as a scientific resource who can provide mentorship to junior staff

What we expect of you

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

Basic Qualifications

Doctorate degree PhD, PharmD, or MD (and relevant post‑doc where applicable) and 3 years of experience in the discipline and/or sub‑discipline.

OR

Masters degree and 6 years of scientific experience.

OR

Bachelors degree and 8 years of scientific experience.

Preferred Qualifications

• PhD with 3+ years of industry experience.
• Strong understanding of small molecule analysis, including chromatographic and spectroscopic techniques, with an emphasis toward separation science, Process Analytical Technologies (PAT) for process understanding and control, structure elucidation, and solid‑state characterization.
• Knowledge of analytical method development and testing requirements toward solid oral dosage support (immediate and controlled release solid dosage forms, liquid formulation or lyophilized formulation), including dissolution method development.
• Solid understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) requirements and their application in a phase‑appropriate manner.
• Hands‑on experience in development, validation, transfer, and remediation of methods for in‑process, release, and stability testing.
• Knowledge of the major Pharmacopeia and International Conference on Harmonization (ICH) / Food & Drug Administration (FDA) guidance documents related to analytical method transfer and validation, impurities, genotoxic impurities, early phase development.
• Experience in technical transfer for non‑GMP and GMP production and testing to external contract organizations.
• Ability to multitask and manage deliverables on complex projects against timelines.
• Strong leadership, problem‑solving, decision‑making, and communication skills with the ability to work cross‑functionally and globally within CMC teams to deliver results.
• Excellent technical writing skills and 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, we 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 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

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.