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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:

Acts as lead on multiple programs. Investigates, creates, and validates new scientific methodologies on a complex scope of projects in a biology environment. Works on technical/scientific project activities to execute strategies and technical solutions that meet client needs and expectations. Participates in technical discussions with clients with a high level of technical proficiency. Evaluates and contributes to the design of manufacturing processes and supports problem solving as necessary with independent judgment. Makes decisions that require developing new options to solve complex problems. Determines methods and procedures on new assignments and may coordinate activities of other employees. Typically assigned to a specific discipline, such as analytical, cell culture, process validation, or purification.

Key Responsibilities:

• Leads design of experimental plans based on the defined deliverables.

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

• Records results in notebook accurately, clearly, and regularly, and reviews documentation by others.

• Prepares protocols, reports, and test methods and writes SOPs.

• Maintains and ensures safe laboratory environment and work practices.

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

• Remains current in the field by review of relevant scientific literature and attendance at appropriate scientific seminars and conferences.

• Cell Culture: Leads design and development of 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 scaleup, media development, harvest (recovery) process development, process range finding, and statistical analysis of data. Oversees media optimization, bioreactor process development, and cell culture clarification.

Frequent Contacts:

Internal

• Department leaders and individual contributors

• Leadership team

• Project leads

External

• Customers

• Vendors

• Other business units

Minimum Requirements/Qualifications:

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

• With Bachelor’s degree, minimum of 8 years of experience related to pharmaceutical manufacturing, process, development or academic laboratory and that includes relevant industry and discipline experience.

• With Master’s degree, 6 years of experience related to pharmaceutical manufacturing, process, development or academic laboratory and that includes at least 2 years of relevant industry discipline experience.

• With PhD, significant practical scientific application directly related to job responsibilities; related industry and discipline experience preferred.

Other Job Requirements:

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

• Advanced and deep knowledge of varied aspects or a specialized aspect of discipline and working knowledge of principles and concepts in other relevant disciplines.

• Strong knowledge of general cGLP procedures and those specific to discipline.

• Strong knowledge of GMP/ GLP regulations in cGMP/ cGLP manufacturing environment. Demonstrated leadership skills.

• Excellent problem solving and critical thinking skills.

• Excellent writing, communication and presentation skills.

• Strong MS Excel, PowerPoint and Word skills. Microsoft Project skills preferred.

• Excellent organization and planning skills.

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

• Ability to design complex studies based on the deliverables.

• Ability to analyze and summarize complex scientific data.

• Ability to author reports, procedures, and other documents.

• 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 and communicate complex decisions.

• Ability to apply complex mathematical concepts to physical problems in areas.

• Ability to apply rigorous attention to detail when executing experimental protocols.

• Ability to perform all process steps and to guide manufacturing on the operation of all process steps.

• Ability to speak effectively before groups of customers and employees.

• Ability to apply complex mathematical concepts to physical problems in areas such as heat and mass transport.

• Ability to lead and mentor less experienced staff.

Additional Detail:

Assignment duration: ​6 months

Position hours: ​Normal business hours; 8:00-4:00, 9:00-5:00

This role temp is Temporary: ​ The candidate is welcome to apply for consideration if a position of interest opens

Interview process: Webex.

Number of interviews? ​1-2

Required experience to be considered: ​Upstream process development experience (mammalian cell culture, fed batch and/or perfusion bioreactors (stirred tank and/or single use), CHO, hands on experience with bioreactors or microbioreactor systems (AMBR15 or AMBR250), DOE, experience with process characterization, experience drafting protocols and reports

What are the intangible skills you’d like to see? ​Primary focus is the technical skillset above, but the ability to function successfully as part of a team, interact with customers, present data ​

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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