Process Development Associate

Amgen Foundation, Inc.; Cambridge (MA); On-site; USD 75,000 - 101,000; Full time

Job summary

Amgen Inc. in Cambridge, MA, is seeking a Process Development Associate to support manufacturing process development.

You will conduct experiments, analyze data, and document results under GMP guidelines, collaborating with senior scientists to implement improvements. The role requires a Bachelor's or equivalent, hands-on experience with protein assays (ELISA) and molecular biology methods (qPCR, DNA isolation), and proficiency with data analysis tools.

Qualifications

• Bachelor's degree or higher is required; other paths accepted with demonstrated scientific experience.
• Associate's degree plus 2 years of scientific experience is acceptable.
• High school diploma with 4 years of scientific experience is acceptable.
• Experience with GMP and regulatory filings (IND, BLA, NDA) is preferred.

Responsibilities

• Develop and implement analytical methods for impurity release testing.
• Perform analytical testing to evaluate residual process impurities in drug substances.
• Prepare technical reports for investigations, characterisation and regulatory submissions.
• Document laboratory activities according to GMP guidelines.
• Generate, analyze and interpret analytical data to support development and regulatory needs.

Skills

Protein assays

ELISA

qPCR

DNA isolation

GMP documentation

Regulatory filings

Data analysis

Office software

Education

Bachelor's degree

Associate's degree

High school diploma

Tools

JMP

R

SAS

GraphPad

Job description

Process Development Associate page is loaded## Process Development Associateremote type: On Sitelocations: US - Massachusetts - Cambridgetime type: Full timeposted on: Posted Todayjob requisition id: R-260871## **Career Category**Scientific#### **Job Description**## Join Amgen's Mission of Serving PatientsAt 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. 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, 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 Associate**## **What you will do**Let's do this. Let's 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:**Bachelor's degreeORAssociate's degree and 2 years of Scientific experienceORHigh 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, we'll 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.## Apply now and make a lasting impact with the Amgen team.## **careers.amgen.com**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 deadlineAmgen 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.#### SponsorshipSponsorship 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 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. 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..**Salary Range**74,503.35USD -100,798.65 USD