Process Development Sr. Associate Scientist- Drug Substance Purification
Amgen
Juncos, Region Metropolitana, PR
hace 6 días

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have.

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.

Become the professional you are meant to be in this meaningful role.

Process Development Sr. Associate Scientist Drug Substance Purification

What you will do

Let’s do this. Let’s change the world. In this vital role you will develop, characterize, monitor and validate processes in support of our Drug Substance manufacturing facilities.

The candidate will develop a deep understanding of the operations and become a subject matter expert for the following processes : protein chromatography purification, filtrations, ultrafiltration diafiltration (UFDF) and Drug substance fill.

The role will support activities including commercial support, process monitoring, data evaluation to support process understanding, improvement of existing processes and / or acquisition on new technologies.

The position requires to have good documentation skills to write reports that can be used in regulatory audits.

Specific Responsibilities include but are not limited to :

  • Provide technical recommendations and guidance for protein purification processes.
  • Evaluate and interprets experimental results and provide recommendations based on scientific data using strong statistical methodologies.
  • Provides continues process monitoring to generate recommendations based on scientific knowledge and statistical evaluations.
  • Provides input to new and existing processes to generate robust and reliable data.
  • Technical lead for process improvement implementation to drug substance processes with reliable and robust data that aligns to Amgen requirements and regulatory expectations to improve productivity and efficiency.
  • Provide on the floor support to commercial operations on a day to day basis providing assessments of product impact and document revisions
  • Apply sophisticated technical principles, theories, and concepts in the development of new process solutions and novel concepts to address specific issues.
  • Establish, leads and / or participate in technical forums for sharing the best methodologies and applications of drug substance processes
  • May support or lead efforts with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and / or highly sophisticated system / facility or process modifications.
  • Communicates and / or presents scientific / technical information within area of expertise across projects within a function / department, and occasionally to the external scientific community (i.
  • e. regulatory agencies, review boards, conferences)

  • Supervise, coordinate and review work of a small team on a project basis.
  • May train and mentor other coworkers.
  • Contributes to and may author scientific / technical documents (i.e. posters, presentations, publications, regulatory marketing applications, patent applications, technical reports, investigation reports)
  • What we expect of you

    We are all different, yet we all use our unique contributions to serve patients. The Sr. Associate Process Development professional we seek is an individual contributor leader with these qualifications.

    The Basic Qualifications are :

    Master’s degree and 3 years of research and scientific or regulated industry experience

    Bachelor’s degree & 5 years of research and scientific or regulated industry experience

    Beyond those the preferred additional qualifications are :

  • Educational background in Life Sciences (Biochemistry or Protein Science is preferred)
  • Experience working in a GMP or highly regulated industry
  • Experience working in Pharma, Medical Devices and / or Biotechnology industry
  • Understanding of protein purification processes (e.g. chromatography, filtration and UFDF systems)
  • Ability to interpret and apply GLP's and GMPs.
  • Advanced laboratory work skills
  • Experience in technology transfer and process validation lifecycle
  • Experience in regulatory filings and RTQs authoring
  • Good understanding of process monitoring and statistical tools
  • Excellent communication skills : oral and written. Interacts effectively with variety of communication and working styles.
  • Fully bilingual in Spanish and English
  • Computer literacy (Windows environment : Word, Excel, Power Point, Minitab)
  • Thrive

    Some of the vast rewards of working here

    As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

  • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
  • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work / life balance, and career benefits with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
  • Apply now

    for a career that defies imagination

    Objects in your future are closer than they appear. Join us.

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