R&D Analytical Development Associate Scientist

Medgene Labs has a single mission: To be a world-class Immunological Services Provider™ for leading livestock producers and their veterinarians. POSITION SUMMARY A Research and Development (R&D) Post License (level depending on experience) will be responsible for performing experiments and tasks in support of R&D projects involving vaccine research for various diseases in multiple species to address customers' needs.

In particular, the scientist will be responsible for conducting, modifying, and developing immunological assays, as well as support of other teams within R&D and throughout the company. The position requires the ability to perform detail-oriented work and successfully integrate

within a strong R&D team. The scientist will report to the R&D Post License Manager and will not have direct reports. JOB DUTIES Perform in both an individual and team setting.

Process clinical samples according to protocol with a high level of detail/accuracy Perform laboratory experiments according to a written method (with supervision level commiserate to experience) Designs and executes experiments (with supervision level commiserate to experience) Perform data analysis, troubleshooting, data presentation and discussion. Perform basic microscopy. Ability to learn and utilize software for set tasks including but not limited to Smartsheet, Compass, Soft Max, Gen5 Treat experiments and

data with a high level of integrity and ethics Able to follow detailed instructions, scientific protocols, and Standard Operating Procedures Strong understanding and application of aseptic technique, biosafety level requirements, and strong adherence to biosecurity practices Keep laboratory documents and logs as needed following ALCOA+ principles.

Maintain quality control checks and a safe environment in compliance with all governmental and laboratory policies, rules, regulations, and codes. Trains other scientists as appropriate for their knowledge and skill level Performs routine laboratory maintenance and upkeep, including cleaning glassware, autoclaving, waste disposal, and equipment maintenance/monitoring as necessary.

Performs literature searches to bring in new techniques or improve current assays. Coordinates with various teams within R&D as well as teams external to R&D Perform other duties as needed. MINIMUM QUALIFICATIONS: Bachelor's degree from an accredited university in microbiology, virology, molecular biology or related field. Knowledge of: General laboratory principles and equipment Biosafety (BSL1 / BSL2) and biosecurity practices Immunological methods and techniques involving both live and inactivated cultures. Cell culture methods including cryopreservation.

Viral propagation techniques and identification Bacterial propagation techniques and identification Microsoft Word and Excel computer skills Ability to: Perform various cell culture growth methods, tests, and analyses. Follow detailed directions and instructions. Work safely with dangerous and contagious materials and specimens. Operate general lab equipment and computers. Perform mathematical computations. Interpret subject matter. Establish and maintain effective working relationships with others. Perform various tests and adapt techniques as required.

Maintain accurate and up-to-date laboratory notebook records. Communicate information clearly and concisely. Job Posted by Applicant Pro

has a single mission: To be a world-class Immunological Services Provider for leading livestock producers and their veterinarians. Medgene is seeking to hire a Process Development and Improvement Associate Scientist for our rapidly growing business and product pipeline.

Purpose: Perform process development and improvement studies as directed by the Process Development and Improvement Leader. Distinguishing Feature: The Process Development and Improvement Associate Scientist is responsible for executing process development and improvement studies for the manufacture of recombinant proteins. The position requires the ability to write, read, and understand standard operating procedures and

be able to execute the procedures to ensure compliance with CVB regulations. Good documentation practices are required while documenting the work that is being performed.

Functions: Read and understand SOPs and Protocols for manufacturing vaccines. Maintains records detailing adherence to established policies. Execute experiments in small scale bioreactors and fermenters to optimize expression and product quality of recombinant biologics. Maintain detailed and accurate laboratory notebooks/batch records. Have proven hands on experience in aseptic techniques. Perform production of buffers, growth media, and solutions. Help maintain laboratory equipment, supplies, and a clean/safe working

environment. Assist with production activities as needed. Work with Production on transfer of products.

Manufacturing of veterinary vaccines in compliance with CVB guidelines and regulations. Maintains appropriate records commensurate with CVB guidelines. Ensures high-quality production standards from culture through bottling. Ensure security of Master Seed, Unreleased, and Released Products. Assist with creating the conditions for increasing productivity by analyzing and improving existing processes as well as improving technology transfers and minimizing losses. Performs other work as assigned. Reporting Relationships: Reports directly to the Process Development and Improvement Leader.

Indirectly reports to the VP of Manufacturing. Challenges and Problems: Challenged to provide effective, safe vaccines to commercial clients in a timely manner. Assist with investigations into poorly-growing cultures, inefficient yields, processing problems. Keeping of detailed records will be an absolute necessity, subject to Audit by the Regulatory and Compliance Officer and Quality Assurance. Decision-Making Authority The Process Development and Improvement Leader is responsible for making experimental decisions involved in the efforts of the position in order to deliver accurate, concise, and timely data.

Decisions may also be delegated to Process Development and Improvement Leader by the Vice President of Manufacturing. Contact with Others: Daily contact with manufacturing, QA, QC, Regulatory, and R&D personnel. Limited contact with Sales and Marketing. Working Conditions: Potential for exposure to human and animal pathogens, including blood-borne pathogens. Exposure to infectious agents, dangerous chemicals, high-voltage equipment, toxic fumes, high-pressure steam, temperature extremes, and potential mutagens. Knowledge, Skills, and Abilities: Knowledge of: BS in Biochemistry, Biology, or equivalent.

Previous experience with fermentation and/or cell culture, chromatography, or other downstream processing techniques. Basic level knowledge and understanding of 9CFR. Basic level knowledge and understanding of hazardous material handling. Aseptic Techniques and good laboratory practices. Good Documentation Practices. Ability to: Follow specific procedures. Work safely with infectious materials and specimens. Operate scientific equipment and computers. Establish and maintain effective working relationships with others. Keep detailed and accurate documentation.

Maintain a safe work environment for self and other employees at all times. Job Posted by Applicant Pro

precisely than previously possible. Medgene Labs has a single mission: To be a world-class Immunological Services Provider for leading livestock producers and their veterinarians. Purpose: Medgene Labs is seeking a Research Scientist to join our growing team and help fully develop our construct bank for viral and bacterial expressed proteins.

The candidate will serve as technical support, providing molecular engineering experience. Primary focus will be to perform daily laboratory assays, maintenance, and optimization of procedures. Distinguishing Feature: The Research Scientist is responsible for support within the Construct Team. Must have a strong background in molecular and immunological

assays, protein production and optimization, and bioinformatics. Coordination and cooperation with Construct Team, Immunological Services, Production, and Quality Assurance departments are essential.

The position requires independent judgement and interpretation under the direct supervisor. Candidates should have a minimum of a Bachelor of Science in Microbiology/Chemistry/Animal Science or related field. Experience preferred, but not required. Functions: Perform molecular cloning efforts by applying molecular biology techniques. Characterization of vaccine candidates by performing molecular biology techniques. Operate and maintain laboratory and experimental equipment. Work collaboratively

with other team members to accomplish project goals and milestones.

Track and document results with Official Documents and Laboratory Notebooks. Creating the conditions for increasing productivity by analyzing and improving existing processes. Monitoring Compliance with aseptic procedures and cleaning schedules as well as occupational health and safety regulations. Ensuring a culture of safety for all employees at VST/Medgene. Performs other work as assigned. Reporting Relationships: Typically reports to the Constructs and Process Development Director, and may provide work direction to Associates, Technicians, and/or students or other staff assigned to the laboratory.

Challenges and Problems: Challenges include performing within established timelines, maintaining accuracy, and consistency due to variance in constructs. Keeping of detailed records will be an absolute necessity, subject to audit by the Regulatory and Compliance. Problems include potential weekend and off-hours work. Decision-Making Authority Decisions include development of specific assays, interpretation of data and communication to appropriate department; what supplies to order; safety and accuracy of equipment; the identity of reference reagents and tests; sources of testing problems; when to contact supervisors for assistance; whether to call service for a piece of equipment; informing management of status of vaccine serials.

Contact with Others: Daily contact with junior technicians, additional staff of VST/Medgene. Working Conditions: Potential for exposure to human and animal pathogens, including blood-borne pathogens. Exposure to infectious agents, dangerous chemicals, high-voltage equipment, toxic fumes, high-pressure steam, temperature extremes, and potential mutagens. Knowledge, Skills, and Abilities: Knowledge of: The methods and techniques of bacterial, viral, mammalian and insect cell culture.

Baculovirus expression vectors and protein production Molecular techniques including transfections, cloning, DNA/RNA extraction and PCR, restriction enzyme digestion Common biochemical and immunological techniques, including SDS-PAGE, UV/Vis spectroscopy, ELISA and western blotting. Laboratory quality controls procedures and appropriate statistical methods. Ability to: Perform various cell culture growth methods, tests, and analyses. Follow specific procedures Work safely with infectious materials and specimens Operate scientific equipment and computers Write detailed SOPs and protocols Identify reference materials Establish and maintain effective working relationships with others Perform various tests, adapt techniques as required, and perform complex computations.

Prepare scientifically accurate and thorough reports. Medgene Core Competencies Accountability and level of Impact Plans and leads completion of project work with team Works autonomously; manages resources; consults with and updates supervisor Technical/Functional Expertise & Application Applies broad knowledge and specialized training in complex scientific principles and techniques Modifies existing processes, procedures and technologies, or develops new ones, as needed May provide training, or technical consultation to others Problem Solving and Innovation Applies methodology and creativity to resolve complex problems to individual accountabilities and project teamwork.

Communication, Collaboration, and People Influence Proactively collaborates and shares information/ better practices within and across Medgene teams, units and departments to influence at the site level. Produces internal written communications; provides input to publications for external use; facilitates team meetings; presents in project teams. Job Posted by Applicant Pro

upgrading plant-based commodities, such as soybean meal, to sustainable, high-quality ingredients. Our company is currently experiencing rapid growth and we are seeking an experienced Analytical Chemistry Manager to join our research and development team. The Analytical Chemistry Manager will lead the work of analytical chemists to achieve R&D established goals.

The successful candidate will have a strong scientific and technical experience in spectroscopy, chromatography, other analytical assay development, validation, and sample analysis to support R&D and the manufacturing plant. In depth knowledge of industry's best practices on analytical methods development and validation are required.

Responsibilities include, but are not limited to the following: Develop methods for HPLC, GCMS, ICP, IC, FTIR, UV-Vis to quantify target molecules in high-quality ingredients Work as the analytical Chemistry lead for the R&D team and serve as the internal / external analytical subject matter experts to develop and drive analytical strategy across the portfolio Define phase-appropriate analytical control strategy and provide accurate and timely quality control data and services to internal staff Help identify and draft SOPs for relevant analytical functions Collaborate with Prairie Aqua Tech leadership to build and implement annual strategic and tactical plans for investments in capital equipment,

operating budget and staffing to support the Company Support the build out and management of analytical team to manage project timelines and analytical deliverables Build a culture of analytical excellence and proficiency through individual and team career development, including active participation in appropriate analytical science societies (e.

g. AOAC, AOCS, ACS, etc. ) In conjunction with process development and new product development, develop innovative and robust analytical tools to support product quality, control, and innovation as well as intellectual property and regulatory requirements. Lead the development and internalization of digital data documentation systems Proactively identify and help to resolve scientific (analytical and process) issues during product development and early commercialization Represent the Analytical team at project team meetings Directly oversee transfer of methods, validation and QC testing to other analytical functions and or CROs and ensure they are executed successfully and with best practices Engage in technical process development and cross functional area team meetings as a subject matter expert for analytical development and investigational product characterization Maintain expertise in the analysis of products and in the processing parameters affecting product quality Work with Regulatory to author regulatory submissions and support responses to regulatory agency questions as needed.

Qualifications: Advanced degree (M. S. or Ph D) in analytical chemistry or related scientific field 3-5+ year of relevant experience in analytical methods development in spectroscopy and chromatography Extensive experience with and knowledge of analytical methods applied to agriculture processing and co-product streams which includes, but not limited to protein, fiber, and carbohydrates. 3-5+ years of experience managing technical staff Ability to work both independently and within team environments Strong data analysis and reporting Ability to scientifically understand, integrate, and communicate diverse analytical dataset Job Location: Brookings, SD Job Posted by Applicant Pro