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PDS Tech Inc Upstream Process Development Scientist in Saint Louis, Missouri

PDS Tech is seeking candidates for an Upstream Process Development Scientist position in St. Louis, MO

Position Summary:

Provides moderately complex analyses in a biology environment within defined procedures and practices. Participates in development of scalable processes with improved product yield and reduced costs in a biologics environment. Supports internal development and/or manufacturing operations. May research and implement new methods and technologies to enhance operations. Makes detailed observations and reviews, documents, and communicates test results; recommends solutions. Maintains lab equipment. Typically assigned to a specific discipline, such as analytical, cell culture, process validation, or purification.

Key Responsibilities:

• Assists with the design of experimental plans based on the defined deliverables.

• Conducts semi-routine and moderately complex tasks and sample analyses to support process development. Works with Process Development and Manufacture groups to trouble-shoot process challenges.

• May function as a process subject matter expert in a cGMP environment.

• Records results in notebook accurately, clearly, and regularly.

• Assists with preparing protocols, reports, and test methods.

• Maintains and ensures safe laboratory environment and work practices.

• Helps to maintain laboratory and order common supplies.

• Executes, records, and evaluates experimental data appropriately, including the writing and revising of process development reports and technology transfer protocols as needed.

• Develops mammalian cell culture processes to support the production and manufacturing of recombinant proteins (including mAbs) under varying levels of direction, including, but not limited to cell culture scale up, media development, harvest (recovery) process development, process range finding, and statistical analysis of data. Performs media optimization, bioreactor process development, and cell culture clarification.

Frequent Contacts:

Internal

• Department leaders and individual contributors

• Project leads

External

• Vendors

Minimum Requirements/Qualifications:

• Bachelor's degree in biology, chemistry, biochemistry, chemical engineering, or a related field.

• With Bachelor’s degree, minimum of 2 years of experience related to pharmaceutical manufacturing, process, development or academic laboratory.

• Relevant industry experience preferred.

• With Master's degree, no experience required; related industry experience preferred.

• Experience using advanced statistical software packages and experience with design of experiments (DoE) software (i.e. MiniTab, JMP) preferred.

Other Job Requirements:

• Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment

• Applied knowledge from the experience of applying the principles, concepts, and practices of discipline.

• Working knowledge of GMP/GLP regulations in cGMP/cGLP manufacturing environment preferred. Solid lab skills. Good problem solving and critical thinking skills.

• Good writing, communication and presentation skills.

• Good MS Excel, PowerPoint and Word skills.

• Excellent organization and planning skills.

• Strong attention to detail and ability to adhere to standards procedures.

• Ability to design and execute tasks and studies based on the deliverables.

• Ability to analyze and summarize moderately complex scientific data.

• Ability to properly document work and write reports.

• Ability to function in a rapidly changing environment.

• Strong attention to detail and ability to adhere to standards procedures.

• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.

• Ability to make decisions that require choosing between limited alternatives to resolve problems of moderate complexity.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

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