- Perform analytical testing applied by the QC Laboratory for evaluation of raw materials, components, and products at various stages of the manufacturing process following established ATMs or SOPs.
- Participate in activities as defined in method transfer/qualification/validation/stability study protocols.
- Review, analyze, interpret, and report data following GDP and ALCOA principles.
- Report and participate in investigations of deviation, OOS/OOT results, CAPA and other related activities.
- Author, review, and revise SOPs and ATMs, as necessary.
- Calibrate, validate, or maintain laboratory equipment when needed.
- Review and maintain laboratory data (including contract laboratories) to ensure accuracy and regulatory compliance.
- Occasional weekend work will be required.
- Perform other duties that may be assigned.
- Scientist I: Bachelor of Science (MS preferred) in a Life Sciences discipline with 1+ years of relevant experience
- Scientist II: Master of Science in a Life Sciences discipline with 3-6 years of relevant experience or Bachelor's with 7+ years of experience
- Sr. Scientist: Ph.D. in a Life Sciences discipline with 2+ years of relevant experience
- 1-3 years of relevant experience working in a Quality Control work environment, preferably in the pharmaceutical industry with knowledge of cGMP is a plus
- Considerable expertise relevant to QC analytical methods used for cell therapy manufacturing including qPCR/dPCR, ELISA, flow cytometry or cell-based assays in a GMP environment.
- Experience in technical writing skills in SOPs and analytical test methods as well as method qualification/validation documentation.
- Excellent written/oral communication and interpersonal skills
- Self-starter with superior analysis and problem-solving skills ranging from simple to sophisticated situations.
- Be proficient in MS Office suite.
- Demonstrates proficiency in current Good Manufacturing Practice (GMP).
- Possess good communication skills to explain information and influence others
- Must have a strong work ethic and demonstrate dependability and timeliness.
- Have a high energy level and a positive outlook coupled with the requisite "can do" attitude.
- Join a high-growth and fast-paced organization
- Defined career path and annual performance review and feedback process
- Comprehensive Benefits Plan, including 100% company paid medical, dental, vision, life Insurance, short-term and long-term disability insurance, and more
- Competitive 401k match
- Paid holidays, sick leave, and annual leave
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Scientist I/II, Quality Control - Rockville, United States - AbelZeta Inc
Description
Job Description
Job DescriptionAbelZeta Inc (AbelZeta) is a biopharmaceutical company focused on the development of novel cancer immunotherapy products. Our core technology involves CAR-T, TCR-T, and tumor Infiltrating lymphocytes (TILs), for the treatment of advanced solid and hematological malignancies. We operate a state-of-the-art facility in Rockville, Maryland with five GMP suites in order to augment its global research and development capabilities and to support clinical development of multiple cell therapy platform technologies in the US.The Scientist, QC position supports the Quality Control group at AbelZeta Rockville GMP facility for IND and Phase I/II GMP manufacturing. The role requires knowledge and experience of scientific concepts, practices, and procedures within the biopharmaceutical field and a cGMP environment. The QC Scientist will focus on supporting the routine operation of the GMP facility in analytical development, batch release, and stability studies, etc.
Responsibilities and Duties:
Qualifications and Requirements:
Preferred Qualifications:
Why You Should Join AbelZeta
AbelZeta is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. AbelZeta validates right to work using E-Verify. Salary at AbelZeta is determined by various factors, including but not limited to location, the individual's particular combination of education, knowledge, skills, competencies, and experience, as well as contract-specific affordability and organizational requirements. The estimate displayed represents the typical salary range for this position and is just one component of AbelZeta's total compensation package for employees.
