Process Development Principal Scientist

BioSpace; Cambridge (MA); On-site; USD 140,000 - 210,000; Full time

Job summary

Amgen is seeking a Process Development Principal Scientist to lead analytical and regulatory efforts within the Attribute Sciences department, guiding development and commercialization of robust manufacturing processes for complex therapeutics.

The role emphasizes strategic analytical leadership across teams and collaboration with Drug Substance, Drug Product, and Product Quality to support regulatory filings.

Qualifications

• Doctorate (PhD/PharmD/MD) with 3+ years of relevant experience.
• Or Master's degree with 6 years of scientific experience.
• Or Bachelor's degree with 8 years of scientific experience.

Responsibilities

• Lead all attribute and analytical aspects of a program in pivotal clinical process development.
• Define analytical control strategies and methods for late-phase programs.
• Lead method transfer and support cGMP manufacturing activities.
• Author CMC sections in regulatory documents and respond to health authorities questions.
• Drive product characterization for regulatory filings and standards.
• Provide expertise in analytical technologies and drive innovation within Process Development.
• Mentor junior staff and develop team capabilities.
• Help define strategies to improve department effectiveness.

Skills

Analytical leadership

Regulatory writing

Method development

cGMP knowledge

Team leadership

Cross-functional collaboration

Education

PhD/PharmD/MD

Master's degree

Bachelor's degree

Tools

Chromatography

Spectroscopy

Analytical method transfer

QA documentation tools

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 Principal Scientist

What You Will Do

Lets do this. Lets change the world. In this vital role you will joining Amgens Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces and optimizes state-of-the-art analytical tools to guide that development. The Pivotal PD organizations focus is developing and commercializing robust manufacturing processes across a wide range of therapeutic modalities, including (but not limited to) synthetic medicines (oligonucleotides and small molecules).

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

• 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 Amgens platform and analytical technologies, helping to drive innovation and efficiency within Process Development
• Help to define strategies that improve the effectiveness and efficiency of the Attribute Sciences department
• Maintain current 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
• Recognized as a scientific resource in area of expertisewho 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 these qualifications.

Basic Qualifications

Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 3 years of [Job Codes Discipline and/or Sub-Discipline] experience

OR

Masters degree and 6 years of Scientific experience

OR

Bachelors degree and 8 years of Scientific experience

Preferred Qualifications

• PhD with 3+ plus 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 process 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 managing 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 details 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.

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.