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Scientific Technician
475 Green Oaks Parkway Holly Springs, NC 27540 US
Job Description
*Depending on experience
Job Description:
The Scientific Associate will work on the analytical development to support the process and product development of mRNA/LNP vaccine products. This role will contribute to assay development and sample testing of in?process samples, drug substance, and drug product using various analytical tools. This position will support process development, product release, stability, and characterization of toxicology and clinical trial materials.
Responsibilities
• Analytical Testing: Execute analytical methods and sample testing in accordance with established SOPs to support process development, product release, stability, and characterization
• Method Development: Collaborate as a core team member to develop and optimize phase?appropriate bioassays and molecular biology assays for mRNA vaccine programs under limited supervision
• Cross?Functional Collaboration: work closely with teams in separation, biophysics, mass spectrometry, and process development to support overall product understanding and characterization
• Assay Transfer and Validation: Act as a liaison between Analytical Development and QC GMP to facilitate assay transfer, qualification, and validation
• Investigation Support: Assist in product, process and testing?related deviations and investigations, including complaint, deviation, OOE and OOS investigations
• Documentation: Ensure all experimental procedures and documentation adhere to the highest quality and regulatory standards. Review documentation in notebooks, ELN and LIMS for specific lab?based processes
• Report writing: Author method protocols, qualification/robustness/validation protocols, and reports to support IND/BLA filing. Contribute to study protocols, characterization reports, and scientific manuscripts for internal and external publication and patent application
• Team Collaboration: Partner with diverse team members from various functions and locations within organization
Minimum Required Qualifications:
• Education: Bachelor’s Degree in related scientific fields with 2+ years of industry experience or master’s degree in related scientific fields
• Experience: Experience in biotech or pharmaceutical development in disciplines such as molecular biology, virology, immunology, biochemistry, biophysics, biomolecular sciences, or analytical chemistry
• Teamwork: Ability to work effectively in a matrixed team environment
• Communication Skills: Strong verbal, written and presentation communication skills in a cross?functional environment
• Attention to Detail: High level of attention to detail and ability to work under tight timelines
• Lominger Competencies: Demonstrated competencies in ethics and values, integrity and trust, decision quality, functional and technical skills, peer relationships, and perseverance
Preferred / Nice to Have Qualifications:
• Regulatory Knowledge: Familiarity with regulatory requirements and experience in a GLP/GMP environment is a plus
• Method Development: Experience in development of bioassays, immunoassays, or molecular biology assays is a plus. Hands?on experience in separation science (CE, HPLC) and particle analysis (DLS) is a plus.
• Experience: Experience in working in the R&D space
• Problem Solving: Demonstrated ability to solve problems and proactively own and drive assigned tasks to completion
• Learning Ability: Eagerness to learn new analytical skills
• Hands?on experience: Experience handling RNA/LNP samples
• Technical Skills: Proficiency in UV?based and dye?based RNA concentration methods, qPCR/ddPCR, immune?based and cell?based assays are highly desired. Competence in operating and maintaining relevant instrument and software.
• Liquid?Handing Experience: Conceptual knowledge, and hands?on experience with liquid?handing instruments such as Tecan, Opentrons, Hamilton, and Assist Plus
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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