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Description:
Qualified individuals will play role in downstream process development; scale up, and technical support of cGMP manufacturing for protein-based vaccines. The candidate will ensure scientifically sound design and scalable purification processes are created. The candidate will also be responsible for generating materials for developmental studies. The candidate is expected to be highly self-motivated, well organized, and very productive.
This position will be located at our Gaithersburg, MD facility and will report to the Manager of Downstream Process Development-Process Sciences group.
Responsibilities include but are not limited to:
Support the development of purification process by reviewing and compiling relevant literature data
Perform scale-up of processes to deliver materials for pre-clinical and clinical studies
Execute optimization experiments to demonstrate that the process is robust with high purity, yield, and scalable for clinical stage manufacturing of vaccine and other biologic product candidates
Design experimental work with supervision of senior scientists
Ability to process complex data and clearly communicate the implications of the results
Generate, manage, evaluate, and maintain critical data in a highly organized manner and provide assessment reports
Provide reagents and other supplies for various projects and departments
Support process characterization studies, process validation and tech transfer process as needed
Maintaining inventory of lab supplies and ordering lab consumables as needed
Responsible for preparation of buffers and column packing at different scales
Performs testing of in-process samples such as SDS-PAGE, Western blot, A280 (Nanodrop), BCA, DNA, and host cell protein ELISA assays
Operates the glass washing instruments and autoclaves as needed
This position is expected to be hands on in the laboratory and scale-up operation
Additional Skills & Qualifications:
Minimum requirements:
MS in relevant scientific discipline with 0-2 years of directly relevant experience
BS in relevant scientific discipline with 4-5+ years of directly relevant experience
Hands-on Downstream purification experience is required
Preferred qualifications:
Knowledge in purification of vaccines/biologics; Experience in various chromatography methods, filtration, and TFF unit operations at bench scale and/or pilot scale is a plus
Capable of performing multiple functions in a fast-paced environment. Strong technical protocol/report writing, and good organization skills are required
Excellent record keeping abilities to adequately record, analyze and document data generated in support of regulatory requirements
Demonstrated verbal and written skills in communicating scientific and technical information
Proficient in Window based software including Excel, PowerPoint and Word
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.
