Process Development Associate

BioSpace; Cambridge (MA); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

Amgen is seeking a Process Development Associate to support manufacturing process development by conducting experiments, analyzing data, and documenting results. You will work with senior scientists and engineers to implement improvements and ensure compliant documentation.

Responsibilities include method development for impurity release testing, analytical testing of residual impurities, and preparation of technical reports for regulatory submissions.

Formación

• Bachelor's degree required; 2+ years with science-related work optional, depending on degree path.
• Experience with protein assays, particularly ELISA, and formats for protein interactions.
• GMP experience and regulatory filings knowledge (IND/BLA/NDA) are a plus.

Responsabilidades

• Develop and implement analytical methods for impurity release testing.
• Perform analytical testing to evaluate residual process impurities in drug substances and intermediates.
• Prepare technical reports for investigations, product and impurity characterization, and regulatory submissions.
• Document laboratory activities according to GMP guidelines.
• Generate, analyze, and interpret analytical data to support development investigations and regulatory submissions.
• Keep abreast of analytical development literature and technology.

Conocimientos

ELISA

qPCR

DNA isolation

JMP

R

SAS

GraphPad

GDP documentation

Electronic Lab Notebook

GMP compliance

Regulatory filings (IND/BLA/NDA)

Microsoft Office

Educación

Bachelors degree

Associates degree

High school diploma / GED

Herramientas

Microsoft Office

ELISA

Descripción del empleo

Basic Qualifications

Bachelors degree

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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

What you will do

Lets do this. Lets change the world. In this vital role you will support the development of manufacturing processes by conducting experiments, analyzing data, and documenting results. They work closely with senior scientists and engineers to implement process improvements.

Responsibilities Include

• Developing and implementing pioneering and fit-for-purpose analytical methods for: impurity release testing.
• Performing analytical testing to evaluate residual process impurities in drug substance and drug substance intermediates
• Preparing technical reports for investigations, product and impurity characterization, and regulatory submissions.
• Documenting laboratory activities according to GMP guidelines
• Generating, analyzing, and interpreting analytical data to support: product development investigations, routine testing, and regulatory submissions
• Keeps current in analytical development field including literature and technology development for groundbreaking and regulatory activities
• Supporting analytical projects involving method development, qualification, and transfer
• Participates in and contributes to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates and documentation.

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

• Bachelors degree
• Associates degree and 2 years of Scientific experience
• High school diploma / GED and 4 years of Scientific] experience

Preferred Qualifications

• Experience and expertise with protein assays, particularly ELISA as well as most common formats for measuring protein-protein interactions.
• Experience and expertise with molecular biology, particularly qPCR and DNA isolation.
• Experience with GDP documentation and Electronic Laboratory Notebook systems.
• Experience working in a GMP regulated environment, as well as with regulatory filings (IND, BLA, and NDA) and ICH Guidelines.
• Experience and expertise with Microsoft Office software, particularly Word, PowerPoint and Excel.
• Experience with data analysis and data analysis software, including JMP, R, SAS, and/or GraphPad.
• Innovation positive approach to challenges; champions new insights and initiatives; brings out and applies others creativity to improve unit performance
• Communication establishes and maintains effective communication mechanisms to keep staff appropriately advised; bridges communication between individuals, units and other organizations as necessary
• Social skills communicates optimally, using appropriate tact and sensitivity; makes others feel respected, valued and understood

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

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.

Amgen is an Equal Opportunity employer

We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements

Please contact us to request accommodation.