Location: Brookings, SD
Company: Medgene Labs
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
Science Jobs are specialized career paths within the field of science that encompass a wide range of disciplines such as biology, chemistry, physics, environmental science, and more. These jobs often require a strong educational foundation and specialized training. Key features of science jobs include a focus on research and development, data analysis, and the practical application of scientific knowledge to solve real-world problems. Additionally, professionals in science jobs are typically engaged in expanding the frontiers of scientific understanding and contributing to technological and medical advancements. These roles can be found in academia, government agencies, private sector research labs, and industrial settings.
Science Jobs refers to a category of employment that specializes in the field of science, encompassing a diverse range of professions including researchers, laboratory technicians, science educators, and many others engaged in scientific disciplines. These jobs are characterized by their focus on inquiry, exploration, and the application of scientific methods to understand the natural world. They often require a strong educational background in science, critical thinking, problem-solving skills, and sometimes, experience with specialized equipment or software. In today's world, Science Jobs are crucial for innovation, technological advancement, and addressing complex challenges in healthcare, environment, and industry.
work and successfully integrate with a strong Manufacturing team. Purpose: Perform daily laboratory operations of Vaccine Production within the site's described procedures. Distinguishing Feature: The Manufacturing Associate Scientist is responsible for manufacturing of vaccines, in accordance with established methods.
Knowledge of basic laboratory procedures and aseptic techniques are preferred. The position requires the ability to 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. 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. Maintenance of all laboratory equipment, facility, and standards within the Vaccine Production division. Assisting with
the planning and organizing of production processes as well as providing guidance and training to staff through instructions and SOPs.
Ensure compliance with aseptic procedures and cleaning schedules. Performs other work as assigned. Reporting Relationships: Reports directly to the Bio Process Sciences Manager. May take direction from Manufacturing Senior Scientists. Challenges and Problems: Challenged to provide effective, safe vaccines to commercial clients in a timely manner. Assist with different problems such as mechanical/equipment failure, contamination, poorly-growing cultures, incomplete inactivation and failure of serial release. Keeping of detailed records will be an absolute necessity, subject to Audit by the Regulatory and Compliance Officer and Quality Assurance.
Decision-Making Authority Decisions may be delegated to Manufacturing Associate Scientist by Bio Process Sciences Manager or Senior Scientist. Contact with Others: Daily contact with manufacturing, QA, and QC personnel. Limited contact with Regulatory, Sales and Marketing, and R&D personnel. 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: Aseptic Techniques and good laboratory practices. Good Documentation Practices. Microbiology background is preferred. Ability to: Perform various cell culture and bacterial growth methods. 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
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
