What are the responsibilities and job description for the QC Method Validation Scientist (Contractor Only) position at Cytovance Biologics?
Job Description:
General Summary:
The successful candidate will work as one of the technical leads for the analytical methods in the QC department. He/she will be responsible for various activities related to analytical method validation including bioanalytical methods, HPLC/UPLC based test methods for protein analysis, method qualification, and method transfer activities in QC department. Duties will be carried out in accordance with quality standards and procedures set by the company and applicable government agencies.
Essential Duties and Responsibilities:
- Prepare method qualification / validation protocols, participate in the execution of the protocols, and prepare final reports per ICH and other regulatory guidelines for various analytical methods for the characterization of biopharmaceutical protein products.
- Take independent role in implementing/trouble shooting various assays/test methods in the QC laboratories.
- Guide and help laboratory analysts during the method validation / qualification / transfer, and platform method verification/evaluation activities in QC department.
- Specify and source new analytical equipment as required to expand the testing capabilities of the QC Analytical Laboratory.
- Serve as one of the technical leads for data analysis including appropriate statistical application as required.
- Draft and review analytical method related protocols, SOP’s, reports, and other documentation to support ongoing activities in the QC laboratory.
- Support the training of new and existing laboratory personnel for Analytical methods including Bioassays.
- Perform and evaluate analytical technology transfers associated with new products or processes to QC laboratory.
- Perform OOS investigation as necessary!
- Analyze laboratory data for trending.
- Participate during the technical discussions between the company team members and clients related to analytical methods.
- Provide support as subject matter expert (SME) during Quality Audits, Client Audits, and Audits by the Regulatory Agency.
- Other duties as assigned.
Job Requirements:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Minimum M.S in Life Sciences/Chemistry with 6 years of academic /industry experience in method development, method validation/qualification and method transfer
- Higher degree (PhD) and laboratory experience dealing with Analytical Method Validation/Qualification for biologics preferred.
- A working knowledge of GMP and good documentation practice (GDP) as it relates to the QC laboratory is desirable.
- Demonstrated expertise with a range of protein/glycoprotein analytical techniques including HPLC/UPLC, ELISA, icIEF, enzymatic, electrophoretic (SDS-PAGE, Western blots, IEF, and CE), and PCR based test procedures. Cell culture and bioassay/potency assay experience is plus.
- Reasonable knowledge and understanding of overall maintenance, calibration, and qualification of the QC laboratory analytical equipment.
- Working knowledge of ICH, ISO and GMP regulatory compliance requirements related to product stability testing is plus.
- Organizational, multitasking, problem-solving, math, statistical, interpersonal, written, and oral communication skills. Detail-oriented and ability to prioritize work.
- Must be able to work within multifunctional teams such as Analytical Development (AD), QA and Program Management.
- Ability to function well in a fast-paced multiple project environment.
- Communicates openly with development, production & quality personnel to resolve problems before or as they arise.
Physical Demands:
While performing the duties of this job, the employee is frequently required to stand; sit and talk or hear. The employee is occasionally required to walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is moderate.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class.
Cytovance Biologics acknowledges that providers may be a valuable resource for identifying and recruiting Candidates for employment. However, we require that all external recruiters engage directly with Cytovance Biologics Human Resources Team and comply with Cytovance Biologic’s requirements prior to transmitting any Resumes/CV’s or introducing any candidates to an employee of Cytovance Biologics. Cytovance Biologic’s Human Resource Team is the only function within the Company that can enter contractual relationships with external recruiters and recruiting agencies.
