SR. QUALITY CONTROL ANALYST I
General Job Description:
This position is located within the Quality Control department and is responsible for performing lot release testing, stability testing, clinical sample testing, and in-process characterization assays utilizing various methodologies including cellular bioassay, ELISA, ddPCR and RT-qPCR and other related Quality Control methods. Additional responsibilities include: qualification of the assays transferred from development group or CTL; draft qualification protocol and qualification report; trending the performance of the reference standard and positive controls; assisting with QC sample accessioning and management; supporting product release, and regulatory submissions; participate in OOS investigation, Deviation and CAPA system.
GenVivo’s mission is to pioneer innovative gene therapies for administration to cancer patients in order to improve patient survival and ultimately to make patients cancer free. Our approach to synergistically kill tumors while activating the immune system to fight the patient’s cancer combined with the integration of novel companion diagnostics, positions us on the cutting edge of cancer immunotherapies and emerging clinical stage cancer companies. We are an ambitious, growing company whose employees are enthusiastic and passionate, respectful of each other, and highly committed to our mission and values. The company thrives on collaboration and since we are currently small, every individual and each idea is important and counts.
Primary Duties and Responsibilities (include but are not limited to):
- Perform ELISA, cell-based potency assays, and ddPCR/RT-qPCR assays in a GLP/GMP regulated environment for Investigational Product lot release, ongoing stability measurements, and assay of clinical research samples;
- Transfer assays from Development group for implementation and qualification;
- May be involved in the development and/or optimization of various assays;
- Participate in formal analytical method transfer and validation studies with internal and external testing laboratories;
- Contribute to the understanding and interpretation of results and how they impact product quality and the design of subsequent experiments;
- Author standard operating procedures, test methods, qualification protocols and reports;
- Support change control and investigation activities;
- Assist with QC sample accessioning and management;
- Maintain lab areas and equipment to GLP/GMP standards including routine cleaning and decontamination of lab benches, biosafety cabinets, and other equipment;
- Participate in equipment and instrument installation, operation, and performance qualification;
- Coordinate calibration and preventive maintenance of equipment;
- Work independently with minimal supervision and direction;
- Maintain close communication and interaction with QC management and staff to ensure on-time completion of assigned activities;
- Fully comply with company health and safety procedures and practices;
- Perform other additional job related duties as required.
- Bachelor's degree in Chemistry or Biology with 9+ or Master’s degree with 7+ industry experience;
- Minimum 5 years hands-on proficiency in ELISA, mammalian cell culture, cell-based assays, and PCR techniques;
- Experience working in a GMP or GLP regulated environment;
- Strong attention to detail and familiarity with GMP documentation;
- Capable of effectively handling multiple projects simultaneously;
- Good understanding of drug development process;
- Good computer skills and working knowledge of common software;
- Excellent organizational and problem-solving skills;
- Excellent verbal and written communication skills, including report writing skills;
- Team player with strong interpersonal skills and proven ability to work effectively in a fast-paced team environment;
- Must be an individual with proven initiative and demonstrated accountability;
- Professional integrity and maturity with high degree of discretion dealing with confidential information;
- Support the mission and strategic plan of the Company and ensure project deadlines and performance standards are met;
- Operate both independently and as a team member depending on current company priorities;
- Ability and willingness to work flexible hours when necessary;
- Applicant must be eligible to work in the U.S.
NO PHONE CALLS PLEASE AND NO AGENCIES OR RECRUITERS.