38 Process Development Sr Associate Jobs in Cambridge, MA
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Process Development Sr Associate
$102k-129k (estimate)
Full Time | Scientific Services
2 Weeks Ago
Amgen is Hiring a Process Development Sr Associate Near Cambridge, MA
HOW MIGHT YOU DEFY IMAGINATION?You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Process Development Sr AssociateLiveWhat You Will DoLet’s do this! Let’s change the world!
Amgen is currently seeking a Process Development Senior Associate for our Pivotal Drug Product Technologies Group in Cambridge, MA. This group is responsible for late stage drug product formulation and fill/finish process development for large molecule modalities (e.g. monoclonal antibodies, bispecific T-cell engagers (BiTEs), and fusion proteins). Working closely with a team of scientists and engineers, the successful candidate will apply scientific and engineering principles to advance the technical aspects of Amgen’s drug product and process development.
Responsibilities Include
Basic Qualifications
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.
Amgen Offers a Total Rewards Plan Comprising 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 Including
careers.amgen.comAmgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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.
Process Development Sr AssociateLiveWhat You Will DoLet’s do this! Let’s change the world!
Amgen is currently seeking a Process Development Senior Associate for our Pivotal Drug Product Technologies Group in Cambridge, MA. This group is responsible for late stage drug product formulation and fill/finish process development for large molecule modalities (e.g. monoclonal antibodies, bispecific T-cell engagers (BiTEs), and fusion proteins). Working closely with a team of scientists and engineers, the successful candidate will apply scientific and engineering principles to advance the technical aspects of Amgen’s drug product and process development.
Responsibilities Include
- Participate in the planning, design, execution, and documentation of studies related to drug product design, formulation development, and process development in support of commercialization and life cycle management of biologics.
- Author and review technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions.
- Actively utilize advanced IS systems to improve drug product design through faster data availability, leveraging historical information, analyzing large data sets, and statistical analysis.
- Create visualizations to enable business application of data analysis.
- Explore and evaluate new digital tools and techniques to improve the team’s developmental and operational capabilities.
- As needed, provide support to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements.
- Support standardization and optimization of departmental practices by contributing to guideline documents.
- Participate in global cross-functional teams working effectively in a highly matrixed team environment to progress product development.
- Deliver progress reports and presentations to ensure management awareness and engagement of the current status, progress, and future program and functional needs.
- Ability to travel domestically and internationally up to 10% of the time.
Basic Qualifications
- High school diploma / GED and 6 years of Scientific experience OR
- Associate’s degree and 4 years of Scientific experience OR
- Bachelor’s degree and 2 years of Scientific experience OR
- Master’s degree
- Master’s degree in Pharmaceutics, Biotechnology, Engineering, Material Science or related discipline.
- 2 years of experience in pharmaceuticals/biotechnology that includes elements of new product development, process characterization, formulation development, equipment design and implementation, technology transfers, statistical process control (SPC), and statistical design and analysis of experiments.
- Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down models, characterization, and scale up.
- Understanding of physical/chemical stability of proteins and how process related stress impacts molecule attributes and product quality.
- Proficiency in at least one statistical software package (such as SIMCA or JMP).
- Experience with coding/scripting for automated data analysis and modeling to enable better access and standardization across the function.
- Strong problem solving and effective cross-functional communication skills.
- Proven ability to learn and act on dynamic information at a rapid pace.
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.
Amgen Offers a Total Rewards Plan Comprising 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 Including
- 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 and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
careers.amgen.comAmgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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.
Job Summary
JOB TYPE
Full Time
INDUSTRY
Scientific Services
SALARY
$102k-129k (estimate)
POST DATE
08/28/2024
EXPIRATION DATE
09/25/2024
WEBSITE
amgen.com
HEADQUARTERS
BOTHELL, WA
SIZE
15,000 - 50,000
FOUNDED
1980
TYPE
Public
REVENUE
$10B - $50B
INDUSTRY
Scientific Services
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About Amgen
Amgen discovers, develops, manufactures and delivers human therapeutics for patients suffering from serious illnesses.
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