Sr. Process Dev. Associate/Scientist

Job Description

TITLE: Sr. Process Development Associate/Scientist, Surface Chemistry and Bioconjugation
DEPARTMENT: Operations-Technology Transfer and Consumable Manufacturing
REPORTS TO: VP Tech Transfer/Consumable Manufacturing

Position Summary

Under minimal supervision, this position is responsible for assisting Technology Transfer, Assay Development, Manufacturing and other team members in carrying out technology development, process development, technology transfer, Quality Control, and manufacturing processes involving a variety of laboratory methods, equipment and procedures.

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Principal Responsibilities

Responsibilities may include but will not be limited to the following as assigned:

  • Acquire knowledge and demonstrate competency of each process and technology for which directly or indirectly responsible.
  • Learn and demonstrate expertise with technical manufacturing processes, procedures and policies in Consumables Manufacturing department.
  • Research and Develop processes, new and improved, verify, validate and implement as per organizational needs and processes dictate with supervisor and appropriate stake holders, opinion leaders and subject matter experts.
  • May draft and revise documents including SOP’s, MRP’s, specifications and in-process or release testing protocols.
  • Perform specialized tasks as trained, become expert (if not current expertise), train and troubleshoot with team.
  • Maintain records of laboratory activities and notebooks in a professional, accurate manner as per QSR, GMP and ISO guidelines.
  • Learn and operate equipment and conduct tasks in a safe manner, adhering to established guidelines and applicable regulations.
  • Collaborate with supervisor to establish objectives, milestones, and timelines for completion. Report progress and results to Supervisor on a regular basis.
  • Operate at a consistent and competent level of efficiency, producing quality and accurate results. Routinely operate to QSR, GMP, GLP, ISO, and safety guidelines.
  • Participate in periodic reviews of component labor routings, material requirements, BOM’s and manufacturing procedure. Ensure information is accurate and up to date.
  • Establish and maintain lines of communication to ensure the timely and accurate flow of information. Coordinate tasks and functions with other staff members in a cohesive and effective manner. Regularly interact with all departments, including but not limited to, representatives from Engineering, Quality, Production Planning, Purchasing, Finance/Accounting and R&D.
  • Participate and or lead new product/process transfers. Ensure required documentation is complete.
  • Exhibit professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
  • Learn and demonstrate a commitment to Genalyte’s Quality Management System per ISO, FDA and other regulatory agencies.
  • Maintain compliance with all company policies, quality systems, and procedures.
  • Perform other duties as assigned.

Essential Requirements

  • BA/BS or MA in Chemistry or Biological Sciences
  • 5-8 years of relevant experience in academic, biotech, medical device, diagnostics or related field
  • Experience with surface chemistry, specifically, bioconjugation of biologically relevant molecules including proteins, peptides, DNA, RNA and small molecule targets
  • Experience with silane deposition on silicon surfaces
  • Experience with various linker chemistry strategies of biomolecules to solid supports or surfaces
  • Experience with analytical chemistry tools such as HPLC, NMR, Mass Spec, Bioanalyzer, XPS, Ellipsometry, AFM and IR
  • Experience with biochemistry tools a plus such as Gel Electrophoresis, Western Blot and ELISA
  • Demonstrated proficiency in carrying out laboratory/research assignments with minimal guidance in an accurate, effective manner
  • Able to work with a variety of people on multiple tasks
  • Knowledge in a variety of lab equipment and their operation
  • Able to independently plan and carry out experiments following established guidelines and accurately summarize results
  • Ability to learn and demonstrate knowledge of federal and other regulations, e.g. QSR’s, ISO, ISO 13485, CMDR
  • Demonstrate problem-solving and troubleshooting skills
  • Good verbal and written communication skills
  • Organized and detail oriented
  • Knowledge and ability to use MS Office, inventory control and other manufacturing systems
  • Ability to work in a team environment

To apply please e-mail Cover Letter and CV to careers@genalyte.com.

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