Process Development Sr Scientist

BioSpace; Cambridge (MA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health and welfare plans

Bonuses

Stock incentives

Flexible work arrangements

Job summary

A leading biotechnology company is seeking a Process Development Sr Scientist to lead drug product commercialization efforts. The ideal candidate will have a strong scientific background with experience in pharmaceutical development and a passion for innovation. This role involves cross-functional collaboration and offers opportunities for professional growth within a dynamic team focused on improving patient outcomes.

Qualifications

• 5 years of scientific experience with Bachelor's; 3 years with Master's; or PhD.
• Experience in pharmaceutical development and manufacturing preferred.

Responsibilities

• Lead process development for pipeline products and support lifecycle management.
• Design and implement formulation and process development studies.
• Conduct data analytics to inform decisions and support manufacturing operations.

Skills

Problem-solving

Project management

Organizational skills

Collaborative skills

Education

Bachelor's degree

Master's degree

Doctorate degree (PhD, PharmD, or MD)

Tools

Statistical software

Data visualization tools

Job description

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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. 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 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 Scientist

What You Will Do

Let's do this. Let's change the world. In this vital role, you will provide technical and project leadership, integrating effective cross-functional collaboration, to ensure success through the Drug Product commercialization process and lifecycle management. Platform capabilities, prior product knowledge, modeling, and data analytics/visualization will be applied to advance Amgen's pipeline. The responsibilities of this candidate will include:

• Participate in Drug Product Commercialization Teams responsible for conducting process development of pipeline products and supporting commercial products through lifecycle management.
• Design, plan, implement, and document formulation and process development studies.
• Apply scientific/engineering principles and techniques to develop, characterize, and implement processes and next-generation technologies, and to solve technical challenges.
• Apply advanced statistical/data analytics techniques to draw conclusions and inform decisions.
• Support clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for process changes/improvements and non-conformance investigations.
• Author/review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions.
• Stay current on industry and scientific community developments to continue innovating and meet future business needs.
• Communicate effectively with management, cross-functional partners, and relevant stakeholders on progress and upcoming needs.
• Ability to travel domestically and internationally up to 10% of the time.

What we expect of you

We value diverse contributions to serve patients. The ideal candidate holds these qualifications:

• Bachelor's degree and 5 years of scientific experience; or
• Master's degree and 3 years of scientific experience; or
• Doctorate degree (PhD, PharmD, or MD).

Preferred Qualifications

• Advanced degree in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Chemistry, Materials Science, Pharmaceutics, or related field.
• Experience in pharmaceutical development and manufacturing.
• Experience in biologics process development, formulation development, fill-finish process engineering, technical transfers, statistical process control, and experimental design.
• Experience with co-formulations, advanced drug delivery technologies, programming, data visualization tools, and statistical software.
• Strong problem-solving, project management, organizational, and collaborative skills in a fast-paced environment.

What you can expect from us

We support your professional and personal growth through competitive benefits, inclusive culture, and rewarding work. The annual salary range in the U.S. varies based on skills and experience. Our total rewards include health and welfare plans, bonuses, stock incentives, time-off, flexible work arrangements, and more.

Apply now and make a lasting impact with Amgen.

Visit careers.amgen.com.

Amgen is an Equal Opportunity Employer and provides accommodations for individuals with disabilities during the application process.