CambridgeRecruiter Since 2001
the smart solution for Cambridge jobs

Senior Scientist

Company: Amgen
Location: Cambridge
Posted on: October 15, 2020

Job Description:

Employer Amgen Location Cambridge, MA, US Posted Oct 05, 2020 Ref R- Discipline Science/R & D, Biotechnology Hotbed Genetown, Ideal Employer Required Education Bachelors Degree Position Type Full time You need to sign in or create an account to save Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is currently seeking a Process Development Senior Scientist for our Commercial Drug Product Technologies Group located Cambridge, MA. This group is responsible for process development and lifecycle management of commercial drug product formulation and fill/finish processes across various modalities (synthetics, large molecule, siRNA, virus, etc.). The Scientist will provide technical and project leadership while integrating information generated by multi-functional teams to ensure success through the commercialization and life-cycle of the products. Responsibilities include: Serve as a leader on Drug Product Commercialization Teams responsible for planning, designing, executing, and detailing laboratory studies related to drug product design, formulation, and process development in support of commercialization and lifecycle management of both parenteral and oral solid dosage presentations management of parenteral products. 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 non-conformance investigations and process changes/improvements. Drive continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering. Participate and lead global multi-functional teams working effectively in a highly matrixed team environment to influence and inspire change, efficiency, and foster positive relationships. Author and review guideline documents, technical protocols, reports, product impact assessments, regulatory submissions, and developing responses to regulatory questions. Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs. Mentor and train junior staff with a particular focus on building technical expertise while enabling further career development Actively utilize sophisticated IS systems to improve drug product design through faster data availability, using historical information, analyzing large data sets, and statistical analysis. Ability to travel domestically and internationally up to 10% of the time. Basic Qualifications Doctorate degree or Doctorate degree completed by March 2020 Masters degree & 4 years of scientific experience or Bachelors degree & 8 years of scientific experience Preferred Qualifications Advanced degree in Pharmaceutics, Biotechnology, Engineering, Material Science or related subject area 5+ years of post-doctoral or industry experience in pharmaceuticals/biotechnology or related field Knowledge of/hands-on experience with end-to-end development for liquid and lyophilized drug products in various presentations Knowledge and awareness of the regulations governing combination product development Experience with unit operation for parenteral manufacturing (i.e. filling, filtration, mixing, etc.), specific scale-down model development, characterization, and scale-up Understanding of physical/chemical stability of proteins and how process related stress impacts product quality, specifically, the impact of freezing and drying to short- and long-term stability Aseptic processing experience and familiarity with cGMPs, ICH guidelines, and pre-approval inspection/audits Experience that includes elements of new product development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments Strong problem solving and effective cross-functional communication skills Proven ability to learn and act on dynamic information at a rapid pace We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment. Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. 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, or disability status. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. 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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. 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, or disability status. More searches like this Science/R & D jobs in Cambridge Biotechnology jobs in Cambridge

Keywords: Amgen, Cambridge , Senior Scientist, Other , Cambridge, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Associate, Claims & Fraud Operations, East Providence, RI
Description: Associate, Claims Fraud Operations, East Providence, RI---2002722-Description-As a member of Santander's retail banking division, you'll help serve Santander's retail and small business customers as (more...)
Company: Santander Holdings USA Inc
Location: East Providence
Posted on: 10/26/2020

CDL A Local Truck Driver - Dedicated Home Daily
Description: Job Description Join the Cowan Family as a dedicated local driver out of Uxbridge, MA. Our drivers on this account make between 57,000 and 63,000 per year. You'll enjoy our newly increased pay packages (more...)
Company: Cowan Systems
Location: Woonsocket
Posted on: 10/26/2020

Front of Store Attendant
Description: Job Description Lot Associates assist customers with the loading of their vehicles and also monitor
Company: The Home Depot
Location: East Providence
Posted on: 10/26/2020


Overnight Stocker
Description: Job Description Position Purpose: Associates in Freight/Receiving positions ensure
Company: The Home Depot
Location: Woonsocket
Posted on: 10/26/2020

Licensed Health Insurance Agent - Massive OEP Opportunity, limited hiring class
Description: Assurance has opened up 100 spots nationally for Licensed Health agents to join our platform by 10/31 Join the revolutionary ASSURANCE platform in time to have the best Open Enrollment Period OEP (more...)
Company: ASSURANCE Independent Agents
Location: Woonsocket
Posted on: 10/26/2020

CDL A Local Truck Driver - Dedicated Home Daily
Description: Job Description Join the Cowan Family as a dedicated local driver out of Uxbridge, MA. Our drivers on this account make between 57,000 and 63,000 per year. You'll enjoy our newly increased pay packages (more...)
Company: Cowan Systems
Location: East Providence
Posted on: 10/26/2020

Distribution Center Team Member - Full TIme - Located in Raymond, NH
Description: br As a Freight Handler at Walmart Supply Chain, you will have a critical role in moving product through our Distribution network to the Stores to service our Customers. Your role is critical in providing (more...)
Company: Walmart
Location: Concord
Posted on: 10/26/2020

Licensed Health Insurance Specialist - Free leads, flexible work schedule
Description: Assurance has opened up 100 spots nationally for Licensed Health agents to join our platform by 10/31 Join the revolutionary ASSURANCE platform in time to have the best Open Enrollment Period OEP (more...)
Company: ASSURANCE Independent Agents
Location: Woonsocket
Posted on: 10/26/2020

Associate, Claims & Fraud Operations, East Providence, RI
Description: Associate, Claims amp Fraud Operations, East Providence, RI - 2002722 Description As a member of Santander s retail banking division, you ll help serve Santander s retail and small (more...)
Company: Santander Holdings USA Inc
Location: East Providence
Posted on: 10/26/2020

Santander Holdings USA Inc: Sr. Representative, Fraud
Description: Sr. Representative, Fraud-2003028 DescriptionAs a member of Santander---s retail banking division you---ll help serve Santander---s retail and small business customers as part of one of the top banks (more...)
Company: Santander Holdings USA Inc
Location: East Providence
Posted on: 10/26/2020

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Cambridge RSS job feeds