Scientist I, Downstream Process Development

Job Description

Job Description

About the Position
As 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:
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

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.

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