Process Development Associate

BioSpace; Cambridge (MA); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Retirement plan

Medical insurance

Stock incentives

Discretionary bonus

Flexible work options

Job summary

Amgen is seeking a Process Development Associate to contribute to Drug Substance Process Development for late-stage biologics, including development, characterization, and scale-up of upstream and downstream manufacturing processes.

You will work with cell culture and purification scientists across multiple modalities, performing small-scale bioprocess experiments, maintaining cultures, and supporting purification and automation efforts. Strong collaboration and communication are essential.

Qualifications

• Hands-on experience with mammalian cell culture and/or purification operations.
• Familiarity with bioprocess development and purification principles.
• Experience with design of experiments and statistical analysis of data.

Responsibilities

• Contribute within a project team on goals such as improving process yield and robustness, and scaling-up processes to manufacturing sites
• Perform small-scale bioprocess experiments that encompass both upstream (cell culture) and downstream (purification) operations
• Cell culture responsibilities may include maintaining cultures in shake flasks, culture bags, and benchtop bioreactors
• Purification experiments include, but are not limited to, protein chromatography, filtration, and UF/DF operations
• Automation programming for benchtop bioreactors, chromatography systems, and robotic liquid handling systems
• Experimental design and data interpretation, leveraging in-house visualization and analytics tools
• Communication of findings through oral presentations and written documentation (technical reports as well as GMP documents to support regulatory filings)
• Provide scientific technical support for technology transfer of processes to manufacturing sites

Skills

Mammalian cell culture

Protein chromatography

Filtration principles

Bioprocess development

Data interpretation

Design of experiments

Statistical analysis

Education

Bachelor's degree in Chemical/Biomedical Engineering or Life Sciences

Associates degree and 2 years of scientific experience

High school diploma/GED and 4 years of scientific experience

Tools

In-house analytics 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 Associate

What you will do

Lets do this. Lets change the world. In this vital role you will contribute towards Amgens Drug Substance Process Development for late stage clinical and commercial biologics programs, including the development, characterization, and scale-up of upstream and downstream manufacturing processes supporting Ph II/III clinical trials to marketing application. This role is within an integrated organization in which cell culture and purification scientists work together to advance Amgen's rich and dynamic pipeline. With Amgen's biology first approach, the position provides a unique opportunity to work on multiple modalities, from antibodies to oncolytic viruses to bi-specifics.

• Contribute within a project team on goals such as improving process yield and robustness, and scaling-up processes to manufacturing sites
• Perform small-scale bioprocess experiments that encompass both upstream (cell culture) and downstream (purification) operations
• Cell culture responsibilities may include maintaining cultures in shake flasks, culture bags, and benchtop bioreactors
• Purification experiments include, but are not limited to, protein chromatography, filtration, and UF/DF operations
• Automation programming for benchtop bioreactors, chromatography systems, and robotic liquid handling systems
• Experimental design and data interpretation, leveraging in-house visualization and analytics tools
• Communication of findings through oral presentations and written documentation (technical reports as well as GMP documents to support regulatory filings)
• Provide scientific technical support for technology transfer of processes to manufacturing sites

What we expect of you

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

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

Preferred Qualifications

• Bachelor's degree in Chemical, Biomedical, or related Engineering; Life Sciences; or other relevant sciences
• Experience and demonstrated interest in laboratory work, particularly hands-on experience with mammalian cell culture and/or purification operations
• Basic understanding of cell culture, protein chromatography, and filtration principles
• Demonstrated ability to identify and solve problems by applying scientific and engineering principles, preferably in a process development environment
• Strong communication and interpersonal skills, and the ability to work flexibly in a dynamic and collaborative environment with diverse team members
• Familiarity with design of experiments and statistical analysis of data

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.

Benefits

• 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.

Additional Information

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.

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.

Our Commitment to Diversity and Inclusion

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.