Associate Scientist, Downstream Process Development

1 month ago


Gaithersburg, United States Actalent Full time
Job DescriptionJob DescriptionJob Title: Associate Scientist, Downstream Process Development

Job Description

We are seeking an Associate Scientist for the Downstream Process Development group. The qualified individual will be responsible for hands-on execution of downstream chromatography and filtration processes in support of process development, scale-up, process characterization activities, and technical support of cGMP manufacturing for proteins, nanoparticles, and virus-like particle (VLP) based vaccines. You will ensure scientifically sound experimental execution, analysis, and reporting, and draft technical development reports summarizing critical data. The ideal candidate is highly self-motivated, well-organized, and an innovative thinker focused on execution with a sense of urgency.

Responsibilities
  • Reproduce the downstream chromatography and filtration processes for generation of representative material in support of process development and characterization activities.
  • Complete scale-up production runs and associated development reports to support technology transfer of processes to manufacturing.
  • Maintain and monitor equipment, and propose modifications to processes or equipment to deliver improvements.
  • Assist in the implementation of new technologies to improve downstream purification production processes.
  • Participate in the technology transfer of processes to the Manufacturing group and external partners and collaborators, including training staff and providing recommendations for equipment to use for scale-up.
  • Generate, manage, evaluate, and maintain critical data and records of all process development operations in support of regulatory requirements.
  • Author technical reports, data analysis summaries, and SOPs as needed, and present scientific findings at internal meetings.
  • Discuss data, draw preliminary conclusions, and design next experiments in conjunction with colleagues and managers.
  • Other duties as assigned.
Essential Skills
  • Experience with small-scale insect and/or mammalian purification process development.
  • Practical experience with small- to mid-scale chromatography systems and tangential flow and normal flow filtration for all typical unit operations used in biomanufacturing.
  • Experience with centrifugation and other cell culture clarification technologies.
  • Excellent verbal, written, and interpersonal communication skills.
  • Excellent troubleshooting skills.
  • Excellent record-keeping abilities to adequately record, analyze, and document process development data.
  • Self-motivated with a strong sense of ownership in areas of responsibility and willingness to accept temporary responsibilities outside of initial job description.
  • Ability to work and collaborate in cross-functional teams (research, development, and manufacturing) in a fast-paced and dynamic team setting with a sense of urgency.
  • Positive outlook coupled with a 'can do' attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles.
Additional Skills & Qualifications
  • BS in Bio/Chem Engineering, Biology, Chemistry, Pharmaceutical Science, Biochemistry, Biophysics, Molecular Biology, Life Sciences, vaccine development, or a related scientific discipline with 3+ years of experience, MS degree with 1+ years of experience in pharmaceutical or biotech companies, or PhD with relevant experience.
Work Environment

This role operates in a manufacturing environment, lab, and office. The position adheres to GMP standards.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

  • Hiring diverse talent
  • Maintaining an inclusive environment through persistent self-reflection
  • Building a culture of care, engagement, and recognition with clear outcomes
  • Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.



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