Batch Record Specialist

Position Summary

We are seeking a Batch Record Specialist who will report to the Executive Director, Quality Assurance. You will support the company’s Quality Assurance vision and objectives and help establish and oversee the implementation of systems and processes that meet or exceed quality standards and regulatory requirements.

Responsibilities

• Review, and verify executed batch records of APIs, drug products, primary and secondary labeling and packaging
• Review and verify analytical data
• Review and assess the relevant quality control results against acceptable limits
• Review and complete records ensuring compliance with applicable SOPs and regulatory regulations
• Communicate with CMOs on missing documentation and error corrections
• Archive of the entire batch documentation in eQMS (e.g. Veeva)
• Report all variances, errors and deviations to supervisor
• Manage records in eQMS
• Able to collaborate on complaint and/or nonconformance reports
• Write and implement standard operating procedures and work instructions for QA processes
• Support inspection readiness, as needed

Qualifications

• Bachelor’s degree in health or life sciences, or related field; or relevant experience
• A minimum of 3 years of experience in quality assurance, commercial pharmaceutical drug manufacturing and GMP’s in the pharmaceutical / biotech industry
• Analytical education/background is preferred
• Working knowledge of regulatory requirements (FDA, EU) and related standards (GxP, ICH)
• Experience in supporting regulatory inspections and interacting with regulatory agencies / health authorities
• Adept at collaborating and communicating effectively with individuals across diverse roles, experience levels, and perspectives
• Excellent written and verbal communication skills, with ability to influence and build credibility at all levels
• Attention to detail and ability to manage multiple processes and documentation requirements
• Strong technical and analytical skills with advanced knowledge in MS Office including Word, Excel, and PowerPoint
• Able to work in a team and independently as needed to ensure timely, accurate, and thorough completion of assignments
• Outstanding organizational skills with the ability to prioritize
• Demonstrated independent and sound decision-making skills; ability to think critically and make decisions in a fast-paced environment
• Continuous improvement mindset; seeking ways to drive innovation and efficiencies throughout the organization
• Flexible and willing to learn; adapting to business and site needs in a dynamic environment
• Maintain a positive, approachable, and professional attitude

About Us

Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications. The company was founded to develop a better way to treat the cellular drivers of tumor growth. Our lead therapeutic candidate, gedatolisib, is an intravenously administered, potential first-in-class PI3K/AKT/mTOR (PAM) pathway inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. Gedatolisib phase 3 clinical development programs are focused on the treatment of patients with HR+/HER2- ABC in the 1L and 2L settings. A Phase 1b/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is on-going. Celcuity is an Equal-Opportunity Employer. Celcuity is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are competitive. For this role, the anticipated base pay range is $70,000 – $100,000 DOE. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience. The successful candidate will be eligible for an annual performance incentive bonus and a new hire equity package. Celcuity also offers various benefits offerings, including, but not limited to, medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.