- Title: Associate Scientist
- Code: RCI-19504
- Location: Irvine, CA 92612
- Posted Date: 09/23/2022
- Duration: 12 Months
- Name:Sumit Rawat
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 232
Contract: 1 year
- Masters with 2-3 years of exp. will also work
- FDA & ICH guidelines exp. would be good to have
- Must have a GMP background
- This is a laboratory-based position
- Excel exp
- Working in biological analytical laboratory
- Familarity with regulations gmp fda and ISO andICH guidelines
- Non-conformance quarterly trend reports, equipment Out of Tolerance investigations, Standard Operating Procedures and Work
- Do not perform testing in lab
- Clinical dev of biological and pharmaceutical work
- Review data and report generated by scientists
- Previous exp working in analytical lab performing exp
- BS in molecular biology, biochemistry is a preference
- ELN or LIMS is a plus
- Familarity with Analytical techniques (HPLC or GCMS or LCMS)
- Must have regulated industry exp.
- Must have 5 years of Analytical/Microbiological laboratory exp.
- Some quality background would be plus with a analytical laboratory exp.
- Minimum would be a Bachelor's degree
- Perform data and document review to ensure data integrity and compliance of laboratory reports including but not limited to Microbiology and Analytical data, method validation, stability and technical reports.
- Draft technical documents including but not limited to OOS and non-conformance quarterly trend reports, equipment Out of Tolerance investigations, Standard Operating Procedures and Work Instructions.
- Oversee critical laboratory instruments and equipment to ensure compliance with qualification, maintenance and calibration schedules. Initiate equipment change control and assist with coordination of set up and qualification activities for new assets. Assist with OOT investigations in the Asset Management System.
- Experienced in GMP regulated drug development environment.
- Knowledgeable of typical data, data types and documentation that are produced in CMC during clinical development of pharmaceutical and biological drugs (e.g manufacturing and QC of clinical trial material, stability testing, test method transfer).
- Strong working knowledge of cGMP, FDA and EMA GMP regulation and ICH guidance documents. Familiarity with CDC compliance requirements for Select Agent Toxin program preferred.
- Must possess a BS in molecular biology, biochemistry, or related field with at least five years of relevant experience.
- Knowledge of GMP, ISO, and FDA regulations a plus.
- Familiar with process and test method validations.
- Excellent communication skills.
- Ability to perform under pressure to meet project deadlines.
What hours and days will this person be working: M-F 8-5
Does this position offer the ability to work remotely on a regular basis or is it an on-site role: Onsite role only
What are the top 5 skills/requirements this person is required have?
- Required Skill 1: Strong working knowledge of data types and documentation produced in CMC during clinical development of pharmaceutical and biological drugs (e.g manufacturing and QC of clinical trial material, stability testing, test method transfer).
- Required Skill 2: Strong working knowledge of cGMP, FDA and EMA GMP regulation and ICH guidance documents.
- Required Skill 3: Experience in GMP regulated drug development environment.
- Required Skill 4: Experience with non-conformance investigations related to analytical testing and equipment out of tolerance results.
- Required Skill 5: Prior experience working in a biologics environment (regulated by CDC).
What years of experience, education, and/or certification is required? BS in molecular biology, biochemistry, or related field with 5+ years of relevant experience.
What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification? Familiarity with CDC regulations around Select Agents and Toxins.
What is the environment that this person will be working in (i.e. group setting vs individual role)? Both group and individual
Is any testing required for this role? Background check for the SRA program for working in biologics laboratory
Other notable details about the environment from the hiring manager about this role : Work environment: office, analytical, microbiology and biologic laboratories (toxins)