Process Development Sr Scientist - Cambridge, MA
Process Development Sr Scientist - Cambridge, MA
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
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. 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 Sr Scientist
What you will do
Lets do this. Lets change the world. In this vital role you will provide technical and project leadership integrating effective cross functional collaboration to ensure success through the Drug Product commercialization process and lifecycle management. Platform capabilities prior product knowledge modeling and data analytics/visualization will be applied to advance Amgens pipeline. The responsibilities of this candidate will include:
Participate in Drug Product Commercialization Teams responsible for conducting process development of pipeline products and for supporting commercial products through lifecycle management
Design plan implement and document formulation and process development studies
Apply scientific/engineering principles and techniques to develop characterize and implement processes and next generation technologies and to solve technical challenges
Apply advanced statistical/data analytics techniques to draw conclusions and inform decisions
Provide support as needed to clinical and commercial fill/finish manufacturing operations through process capability analysis troubleshooting root cause analysis and product impact assessments for process changes/improvements and non-conformance investigations
Author/review guideline documents technical protocols reports product impact assessments and regulatory sections in support of IND and marketing application submissions
Stay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needs
Effectively and consistently communicate with management cross-functional partners and relevant stakeholders on progress towards milestones and forthcoming program needs.
Ability to travel domestically and internationally up to 10% of the time
Additional Qualifications/Responsibilities
What we expect of you
We are all different yet we all use our unique contributions to serve patients. The Scientific professional we seek is an individual with these qualifications.
Basic Qualifications:
Bachelors degree and 5 years of Scientific experience; Or
Masters degree and 3 years of Scientific experience; Or
Doctorate degree PhD OR PharmD OR MD
Preferred Qualifications:
Advanced degree in Chemical Engineering Biochemical Engineering Mechanical Engineering Chemistry Materials Science Pharmaceutics or related field
Experience in pharmaceutical development and manufacturing
Experience in biologics process development formulation development fill-finish process engineering technical transfers to global manufacturing sites statistical process control (SPC) and statistical design and analysis of experiments
Experience with development and characterization of co-formulations
Experience with advanced drug delivery e.g. sustained release technologies targeted delivery systems microfluidics
Experience with programming (e.g. Python R MATLAB) and database languages (e.g. SQL) as well as data visualization tools (e.g. Tableau Spotfire D3js)
Proficiency in at least one statistical software package (e.g. SAS JMP or Minitab)
Critical thinking problem solving and independent research skills
Strong project management skills including the ability to manage ones project resources (material manpower time etc.)
Good organizational skills with strong attention to detail
Strong ability to operate well in a fast-paced matrixed environment and collaborate successfully cross-functionally
What you can expect from 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 including remote and hybrid work arrangements where possible
Salary Range
127764.00 USD - 152656.00 USD
Required Experience:
Senior IC
Employment Type
Full Time
