Duration: 1 Year
- Provide tech transfer project to enable completion of process validation and health authorities submission technical packages. Responsibility includes:
- Develop and execute logistics for analytical data supportive of technical and process validation studies. This includes: coordination with Manufacturing, Process Engineering, Quality Control, and Process Technical Development on non-routine sampling request, sample aliquoting, sample shipment, testing lab coordination, and test results compilation.
- Collaborate with Process Engineering and Quality Assurance to translate qualification runs batch genealogy into run context.
- Develop and execute translation of electronic batch records into process summary.
- Perform data verification of translated information from electronic batch records into process summary.
- Prepare technical package for data summary and supportive information to support conclusion of technical and process validation studies.
- Provide support on technical documentation logistics.
- Creates and maintains dashboard communication and visual management strategies to track activities assigned for ease of reporting to project lead(s).
- Occasionally, the position may involve some work during non-business hours.
- Solid understanding of basic engineering techniques and principles, and the ability to apply that knowledge.
- Must be able to clearly communicate information to a varied audience and good technical writing skills
- Effective communication and interpersonal skills with technical, operations, quality personnel as well as project/process engineering personnel
- Thorough understanding and application of cGMP's particularly as they relate to the Good Documentation Practices (GDP)
- Outstanding organization and attention to detail
- Ability to adapt to changing priorities
Ability to work independently, seek stakeholders input, and drive assignments to completion
Knowledge or previous experience on monoclonal antibody production processes and statistics (including the use of statistical software such as JMP) is highly desirable
Minimum of 2 years of related experience, preferably in the B.S./M.S./Ph.D. in Chemical/Biochemical Engineering, or other Engineering/Life Sciences majors
Why Work Here?inSync Staffing is a staffing agency supporting over 90 Fortune 500 clients for their national contract needs. Our clients move very quickly in their contract hiring decisions. inSync Staffing is also 100% USA based, you will always be communicating to someone here in the USA!
inSync Staffing is 100% based in the USA and provides employment services and support to over 90 Fortune 500 clients nationwide!