- Ph.D. in Chemical/Biochemical Engineering, physical, chemical, or related Biological Sciences
- 0-3 years of experience in the Pharmaceutical/Biotech industry
- Experience in downstream process development of biopharmaceuticals from mammalian cells
- Experience with scale-up and tech transfer to support pre-clinical and clinical development
- Experience with purification of complex bi-functional proteins
- Experience with host cell protein reduction using novel methods
- Experience with high throughput automation is a plus
- Experience with DOE based downstream process development
- Working knowledge of cGMP manufacturing processes for biopharmaceuticals
- Experience in authoring technical reports
- Excellent written and verbal communication skills
- Detailed knowledge of downstream processing of mammalian cell culture harvests
- Experience with data analysis tools and developing scale down modeling workflows
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Scientist I, Downstream Process Development - Durham, United States - SHATTUCK LABS, INC.
Description
Job Description
Job DescriptionAbout the PositionAs the downstream Scientist I - II, you will be a member of a team with experienced scientists. This team is responsible for downstream process development, scale-up, and technology transfer of purification processes for the clinical manufacturing of Shattuck pipeline biopharmaceuticals expressed in mammalian expression systems.
Summary of Key Responsibilities
Responsibilities will include high-throughput resin and buffer scouting, support process development activities including experimental design, data analysis, authoring and reviewing technical protocols and reports, support technology transfer into the pilot plant, generate documents for internal and external manufacturing of clinical stage programs. Primary responsibilities will include downstream processing lab support, development and optimization of clinical entry and late phase downstream processes, technical support during transfer to manufacturing facilities, and support documentation drafting and review for regulatory submissions. Routine collaborative interactions with Upstream Process Development, Analytical, Research, Quality, and Regulatory groups at Shattuck is a must. Provides hands-on support to execute lab scale process development, pilot scale methods transfer and actively support outsourced cGMP campaigns, including batch record review and deviation investigations. The downstream process development Scientist will be actively involved in working with Technical Operations leadership to develop strategic plans for Shattuck's assets.
Required Qualifications and Skills
We are looking for professionals with these required skills to achieve our goals:
Note to External Recruiters: Our Human Resources department manages all open positions and candidate recruitment. We kindly ask that recruiters not contact employees or hiring managers directly to present candidates or solicit business. Please note that we will consider failure to comply with this request when determining whether to enter into a professional relationship with a recruiting agency. Please also note that submission of unsolicited resumes does not create any obligations for Shattuck Labs, implied or otherwise.
Scientist I, Downstream Process Development professionals in Durham
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Dishant Gada
Business Analytics Graduate