Technical Writer
Analytical Methodologies for potency, impurities, content, and identity attributes in biologics (recombinant proteins, antibodies, ADCs, fusion proteins, enzymes, etc.).
(i.e.: cell based assays, residual ProteinA, host cell protein, residual DNA, protein determination) If possible, proven hands-on testing experience in QC laboratories.
location: Lexington, Massachusettsjob type: Contract
salary: $65.00 - 73.87 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- non-laboratory support of the QC analytical methods functions in method validation and method transfer projects.
- Authoring analytical method and support documentation for QC release and stability testing of biologics.
- Authoring method validation protocol and reports to support technology transfers.
- Creation, review, and revision of comprehensive method validation protocol, reports, , ensuring accuracy and adherence to ICH, FDA, EMA, regulatory standards.
- LIMS and Empower software platforms
- Expert knowledge in data analysis.
- Experience on test methods and method validation for internal teams and external partners.
- Must have knowledge of periodic documentation of assay trends, to maintain compliance and improve operational efficiency
- Skilled in proper laboratory compliance through detailed documentation practices.
- Experienced in the use of electronic laboratory notebooks and electronic data storage systems to maintain accurate records.
skills: Quality control, LIMS (Laboratory Information Management System
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.