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