Process Development Associate Scientist- Biological and Structural Characterization

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

Benefits offered by this job

Retirement plan

Medical/dental/vision coverage

Life and disability insurance

Flexible spending accounts

Bonus program

Stock-based incentives

Paid time off

Flexible work model

Job summary

Amgen is seeking a Process Development Associate Scientist in Cambridge, MA. You will develop and transfer analytical potency and biological characterization assays, supporting sample testing and regulatory submissions.

The role requires Masters or Bachelors with relevant experience in cell culture, bioassay development, and analytical science. You will collaborate with cross-functional teams, generate data, and contribute to technical reports and project milestones while maintaining rigorous

Qualifications

• Masters degree and 1 year of scientific experience
• OR
• Bachelor's degree and 3 years of scientific experience
• Expertise in cell culture, and cell biology techniques for quantitative determination of biological activity of proteins
• Expertise in cell-based bioassay development (characterization methods, qualification, validation, technical transfer)
• Expertise with signal transduction, gene expression, receptor binding and fluorescent probe technologies
• Experience in molecular biology techniques to manipulate plasmid constructs for generation of transfected stable cell lines
• Innovation supports new ideas and initiatives
• Detail oriented and excellent documentation skills
• Experience with automated liquid handling preferred
• Client orientation establishes effective and responsive relationships with all clients; ensures value is delivered
• Communication and Interpersonal skills communicates effectively with others, using appropriate diplomacy and sensitivity; makes others feel respected, valued and understood; works well in teams

Responsibilities

• Developing, qualifying and transferring state-of-the-art analytical potency and biological characterization assays for release testing, stability testing, product characterization, reference standard characterization, and investigations
• Assisting in the preparation of technical reports for investigations, product and impurity characterization, and regulatory submissions
• Generating and analyzing analytical data to support product development and regulatory submissions
• May contribute to analytical development teams by providing analytical updates, documentation and data interpretation; keeps current in the analytical development field

Skills

Cell culture expertise

Bioassay development

Molecular biology techniques

Analytical data analysis

Documentation skills

Regulatory submission support

Education

Master's degree in a scientific field

Bachelor's degree with 3 years experience

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 Associate Scientist- Biological and Structural Characterization

What You Will Do

Lets do this. Lets change the world. In this vital role you will be responsible for developing, qualifying and transferring state-of-the-art and fit-for-purpose quantitative potency and biological characterization assays and supporting sample testing and regulatory submissions.

• Implementing state-of-the-art and fit-for-purpose analytical potency methods for: release testing, stability testing, product characterization/optimization, reference standard characterization, and investigations
• Assisting in the preparation of technical reports for investigations, product and impurity characterization, and regulatory submissions
• Generating and analyzing analytical data to support: product development and regulatory submissions
• May contribute to critical analytical development teams (e.g., product and process development teams, product quality teams) by providing analytical updates, analytical documentation and data interpretation. Keeps current in analytical development field including literature and technology development. Supports analytical projects involving method development, qualification, and transfer

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications

Masters degree and 1 year of scientific experience

OR

Bachelors degree and 3 years of scientific experience

Preferred Qualifications

• Expertise in cell culture, and cell biology techniques for quantitative determination of biological activity of proteins
• Expertise in cell-based bioassay development (characterization methods, qualification, validation, technical transfer)
• Expertise with signal transduction, gene expression, receptor binding and fluorescent probe technologies Experience in molecular biology techniques to manipulate plasmid constructs for generation of transfected stable cell lines
• Innovation supports new ideas and initiatives
• Detail oriented and excellent documentation skills
• Experience with automated liquid handling preferred
• Client orientation establishes effective and responsive relationships with all clients; ensures value is delivered
• Communication and Interpersonal skills communicates effectively with others, using appropriate diplomacy and sensitivity; makes others feel respected, valued and understood; works well in teams

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.

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.

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.