Jobs Posted on the Whova Community Board of 2021 Inspiring Women Leaders Conference
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Senior Engineers, Analysts, Interns & More!
Infotech Infotech is currently hiring for Senior Software Engineers, Senior Front End Engineers, and Solutions Engineers. We're also hiring for a few internship roles, and an economic and statistical analyst consultant. Learn more about these roles on our careers page! www.infotechinc.com/careers/
Biomanufacturing Associate I-III
Ology Bioservices Essential Position Responsibilities:
Assist with upstream related activities including cell culture at small and large scale, cell transfection, media and buffer preparation, and bioreactor and fermenter-based production. Assist with downstream related activities including chromatography purification, centrifugation and ultracentrifugation, ultrafiltration/ diafiltration, and viral clearance. Assist in drafting Standard Operation Procedures, Change Controls, and Deviations. Properly disinfect and stage materials into production rooms before the production campaigns. Assist with equipment ordering, installation, qualification and routine maintenance. Assist with drafting and reviewing Production batch records and review executed records. Assist in writing raw material specifications. research, source, and order material and lab wares. Assist with change-over cleaning in the manufacturing core and other production areas. Assist activities to support production campaign such as preparation of tubing assemblies, autoclaving, material request, and material transfer into production rooms. Adhere to safe working practices. Provide other assistance as needed to the Biomanufacturing Associates, Biomanufacturing Supervisors, and Managers
System Administrator I
Ology Bioservices The Systems Administrator 1 is primarily responsible for administrating and maintaining physical/virtual operating systems in support of business processing requirements. This position will install, upgrade, and patch operating systems and complex software packages, which will be scheduled in accordance with established IT policies and procedures. The Systems Administrator 1 will provide tier-2 support to the IT team and IT's customers Requirements: Experience working in highly-regulated industry (especially GMP) preferred Proficient with virtualization, specifically VMware MCSA or certifications highly desirable Database administration experience desirable Work independently and as a team Carry projects through to completion Self-motivated, take initiative Top-notch problem-solving skills Occasional after-hours / weekends required Attention to detail
Manager, Cell and Gene Therapy
Ology Bioservices Summary: Ology Bioservices, Inc. is an established Contract Development and Manufacturing Organization (CDMO) that is headquartered in Alachua, FL. Ology is setting up a new site in Alameda, CA that will be focused on cell and gene therapy process development, cGMP manufacturing and Quality Control testing for our customer's product lines. The Manager, Cell & Gene Therapy Manufacturing will be a foundational hire for the CA site and will report to the Director, Cell & Gene Therapy Manufacturing.
Requirements: Minimum B.S. (Biology, Microbiology, Chemistry, Engineering or equivalent) A minimum of five years of experience working in cell and/or gene therapy manufacturing environment with at least 1 of those years in a supervisor or management capacity. Hands on experience with either autologous and allogeneic cell therapy manufacturing processes or viral vectors for gene therapy. Knowledge of cGMP and CFR requirements. English reading comprehension and legible writing skills. Strong oral/ written communication skills in a teamwork environment.
QC Technical Writer
Ology Bioservices Principal responsibility is to perform QC level review of data generated in the QC labs prior to subsequent QA review. Following SOPs in performing cGMP data review generated by QC laboratories. Assist with the development and writing of Test Methods, SOPs, Work Instructions and all other documentation required in accordance with established and current quality requirements.
Bachelor’s degree in Biochemistry, Biology or Microbiology or related field At least 4 years of experience in a GMP laboratory Must be familiar with cGMP/GLP practices and ICH and FDA Guidelines. Strong verbal/written and interpersonal communication skills as a team player and willing to work in an environment where individual initiative, collaboration and accountability are valued. Ability to work independently with minimal supervision.
Director, Quality Site Lead
Ology Bioservices The Director, Quality Site Lead will provide strong leadership and strategic direction to the entire quality organization across the Alameda, CA site. This individual will work collaboratively with corporate and site leadership to ensure a smooth manufacturing process that ensures customer work and projects are completed on time and within regulatory and customer guidelines.
Bachelor’s degree or higher, with a focus in Engineering, Life sciences, or similar scientific/technical field A minimum of 15 years of relevant and current Quality Assurance/Control work experience in pharmaceutical / biotech / CDMO industry with extensive knowledge of CGMP, pharmaceutical manufacturing, Quality Control and Quality Assurance Expert knowledge of GMP, FDA and EMA regulatory requirements (21CFR1271 – Human Cells, Tissues, Cellular and Tissue-Based products) as applicable to Biologics including Cell/Gene/Viral therapy products A minimum of 10 years of progressive people leadership and workforce engagement. Experience in leading and managing regulatory audits and testing department/activities Completion of training in quality systems. Demonstrated Project Management skills leading multidisciplinary teams across a site in manufacturing investigations providing critical project deliverables according to established timelines Must have expert knowledge in CGMP compliance including authoring/implementing SOP and policies to ensure CGMP compliance as well as auditing for R&D and commercial manufacturing Experienced in the root cause analysis and corrective action generation for manufacturing investigations including all required documentation (OOS/OOT) Experienced in writing and reviewing of Chemistry, Manufacturing and Controls (CMC) sections for regulatory filings
Associate Director BioAnalytical
Ology Bioservices Summary: Ology Bioservices, Inc. is an established Contract Development and Manufacturing Organization (CDMO) that is headquartered in Alachua, FL. Ology Bio has a new site in Alameda, CA that will be focused on cell and ex vivo gene therapy process development (C>), cGMP manufacturing and Quality Control and BioAnalytical testing for our customer's product lines. The position is expected to lead current bioanalytical operations and build cell and ex vivo gene therapy analytical test methods. The BioAnalytical Associate Director position will be a foundational hire for the CA site and will report to the Director, or Executive Director, Process Development California
Candidate must have the following:
Minimum B.S. (Biology, Microbiology, Chemistry, Engineering or equivalent) – Masters or PhD preferred. A minimum of 8 to 10 years of experience working in cell and/or gene therapy manufacturing environment with at least 3 of those years in a supervisor or management capacity. Hands on experience with either autologous and allogeneic cell therapy analytical procedures or cytometry for gene therapy. Strong experience in managing GXP Lab day-to-day operations is required with demonstrated ability to interact with interdisciplinary teams. Knowledge of cGMPs and cGLPs applicable to the Cell Assay laboratory. Proficiency in ELISA type assays (colorimetric, fluorimetric, chemiluminescent, etc.) and/or qPCR molecular assays. Experience in implementation of data analysis software (SoftMaxPro, PLA or similar) preferred. Strong analytical problem-solving and troubleshooting skills. English reading comprehension and legible writing skills. Strong verbal / written and interpersonal communication skills as a team player and willing to work in an environment where individual initiative, collaboration and accountability are valued.
Analytical Chemistry Associate Scientist
Ology Bioservices Essential Position Responsibilities
Independently perform analytical methods qualification. Perform testing in support of product release, in process testing, and raw material testing. Development and maintenance of procedures (SOPs), protocols, and reports in the department. Participate in laboratory administration, including out of specification and non-conformances, progression of change controls, SOP reviews and closure of assigned activities. Perform other duties as assigned and directed.
Requirements Minimum four year degree in Chemistry, Biochemistry or related field. Minimum three to fives years cGMP / cGLP pharmaceutical laboratory experience. Hands on experience and knowledge of HPLC, FT-IR, and UV/VIS spectrophotometry and other methods. Strong analytical problem solving and troubleshooting skills. Demonstrated verbal and written communication skills and strong inter-personal and communication skills are a must. Ability to work independently with minimal supervision
Director of Human Resources
SharpSpring SharpSpring is a Gainesville, FL-based, publicly traded SaaS company (NASDAQ: SHSP) offering a sales and marketing management platform with powerful automation capabilities. Our team has grown to over 235 employees, with ~25% working from home offices across the country. And we’re looking for our next Director of Human Resources!
This position plays a critical role on the Senior Management team, leading all people operations for this dynamic, fast-growth technology company. We are looking for an experienced, proven HR leader ready to build on our established processes and programs with new knowledge, ideas, and experiences. This is a unique and exciting opportunity to step into leading a team of productive, dedicated HR and Talent Acquisition professionals in an organization where people and culture are valued and celebrated.