Scorpius BioManufacturing is an innovation-driven contract research, development and biomanufacturing organization offering clients a customized, integrated, end-to-end solution for their large molecule discovery research, process and analytical method development, cGMP manufacturing, product characterization, release testing needs, and clinical trial support. Our approach enables us to forge collaborative client relationships that move beyond the traditional service outsourcing model into full product development collaborations.
Reporting directly to the Principal Scientist/Group Leader, Scientist I will work with the laboratory team to achieve the contract research milestones. The candidate will perform assay development, method qualification, preparation of assay development & qualification plan / reports, method validation, writing standard operating procedures (SOP) under the direction of Principal Scientist / Group Leader. The candidate will also be involved in the execution of experimental protocols, data analysis, and preparation of test reports. The employee will be involved in analytical work to support clinical trials as well as for the CMC / biomanufacturing team. It is expected that up to 75% of the employee’s time will be spent at the bench.
The ideal candidate must be organized, initiative-taking, and thrive in a fast-paced and dynamic biotech environment. He/she must be versatile and adapt to rapid change with a strong desire to make a significant impact.
- Perform assays for characterization of large molecules including monoclonal antibodies and recombinant proteins (to determine purity, potency, and other desired attributes).
- Perform biochemical assays to support Pharmacokinetic and Pharmacodynamic (PK and PD) studies.
- Perform multiplex ligand binding assays using various platforms (Ella, Luminex, MSD).
- Perform various biochemical techniques such as HPLC, SEC, IEF, SDS-PAGE, CE-SDS, SPR (Biacore), Western blot, etc.
- Perform routine maintenance of key instruments.
- Prepare standard operating procedures (SOP), assay development reports, method qualification plan, qualification reports.
- Adhere to Good laboratory Practices (GLP), records all data / procedures in the lab notebook / electronic lab notebook.
- Develop and execute laboratory work plans/schedules independently but as per client / customer expectations and metrics.
- May perform lot release testing and stability testing or transfer assays to QC team members. May develop and execute test method suitability studies in a GXP environment.
- May be designated to lead projects based on the experience. Attend client meetings and participates in discussions.
- Attend relevant conferences and present capabilities and scientific data.
- Train new staff on instrumentation and laboratory techniques.
- Perform other work-related duties as assigned and directed by the Supervisor / Director.
EDUCATION & EXPERIENCE
- BS or MS degree from an accredited college or university with major coursework in a scientific discipline required.
- 1+ years of biological analytical characterization required.
- Must have experience of working in Biotech/Biopharmaceutical industry / clinical research facility and following Good Laboratory Practices (GLP) and /or Good Manufacturing Practices (GMP). Experience of working with external clients is a plus.
- Experience of various biochemical analytical techniques.
- Experience with Graphpad Prism is desired.
- Experience of other techniques (qPCR, flow cytometry, ELISPOT) is an additional plus.
KNOWLEDGE & SKILLS
- Outstanding people skills, teamwork, ability to build strong relationships with cross-functional team members and lead by example.
- Ability to take responsibility and “get the job done” in a high-energy, high-intensity, results-oriented environment.
- Excellent verbal and written communication skills, strong presentation skills.
- Must possess good to excellent writing and PC skills with a knowledge base in Microsoft Word, Excel, Power Point, and Project.
- Working knowledge of FDA and other regulatory agency guidelines is preferred.
PHYSICAL REQUIREMENTS and working Environment
- Flexibility is required for working hours. Some weekend work may be needed and earlier or later start/finish times may also be required.
- The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and laboratory environments and automated equipment.
- While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus. The employee must have the manual dexterity and manual ability to effectively use computer terminals.
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