The Director of Quality Control (QC) for proteins, assay kits, cell culture media, cell lines, lentiviruses, and detection buffer products plays a vital role in maintaining the integrity, functionality, and regulatory compliance of these products in drug discovery and development. This position requires strong management and leadership skills as well as technical skills. Below are the key responsibilities and requirements for this role:
Responsibilities:
Product Testing and Validation:- Protein and Assay Kit QC: Oversee the testing of raw materials, intermediates, and final assay kits to ensure accuracy, sensitivity, specificity, and consistency.
- Cell Culture Media QC: Ensure that cell culture media batches meet all required sterility, pH, osmolality, and nutrient composition specifications.
- Cell Line QC: Validate cell lines for identity, purity, functionality, viability, and contamination (e.g., mycoplasma, bacterial, or viral contamination).
- Detection Buffer QC: Ensure the buffer's stability, sensitivity, and compatibility with assays, testing for contamination and chemical properties to guarantee optimal performance in bioluminescence assays.
- Batch release: Review and approve batch records, ensuring each lot of proteins, assay kits, cell culture media, cell lines, and detection buffers complies with quality standards before release to market.
Method Development and Validation:- Develop and validate QC testing methods for new and existing products, ensuring they are reliable, repeatable, and compliant with ISO 9001:2015 standards.
- Validate assay sensitivity, specificity, and robustness for the detection buffer and ensure cell culture media supports consistent cell growth and assay performance.
Data Integrity and Compliance:- Ensure all QC data is documented accurately and in compliance with Good Documentation Practices (GDP) and electronic record-keeping regulations like 21 CFR Part 11.
- Maintain a robust Quality Management System (QMS) to ensure traceability and compliance with ISO 9001:2015 standards.
Team Management and Development:- Lead and mentor the QC team, ensuring staff are trained on relevant SOPs, quality standards, and testing protocol.
Deviation and Non-Conformance Management:- Investigate non-conformances, out-of-specification results, and product failures, and implement corrective and preventive actions (CAPA).
- Conduct root cause analyses and work with cross-functional teams to mitigate risks and prevent recurrence of quality issues across all product lines.
Regulatory Compliance and Audits:- Ensure that all QC activities adhere to the relevant regulatory frameworks, including GLP for testing, and ISO 9001:2015 standards. Prepare for and manage customer audits, and internal quality audits.
- Maintain updated documentation of quality systems, batch records, and testing protocols for audits.
Continuous Improvement:- Drive process improvement initiatives to enhance QC efficiency and accuracy, including the introduction of automation or advanced technologies to streamline testing. Implement Lean, Six Sigma, or other continuous improvement methodologies to reduce errors and enhance product quality.
Cross-Functional Collaboration:- Work closely with R&D, manufacturing, and quality assurance (QA) teams to ensure QC considerations are integrated into product development, scale-up, and production.
- Coordinate with suppliers to ensure raw materials for media, buffers, and kits meet quality specifications.
Requirements:
Educational Background:- Advanced degree (preferred) in a relevant field such as Biotechnology, Molecular Biology, Biochemistry, Cell Biology, Analytical Chemistry, or related life science disciplines.
- Advanced degrees PhD is often preferred for leadership roles in complex QC environments, particularly for managing multiple product categories like proteins, assay kits, and cell lines.
Experience:- Minimum 10 years of experience in quality control within the life sciences industry, with a focus on proteins, assay kits, media, or cell-based products.
- Proven experience in leading QC for diverse product lines, including assay kits, cell culture media, cell lines, and detection buffers.
- Strong knowledge of regulatory frameworks (ISO 9001:2015 and cGMP) related to QC for biologics, diagnostics, and related products.
- Experience with analytical method development, batch release protocols, and product testing validation for multiple product categories.
- Experience in leading teams and overseeing QC labs, including proficiency in biochemistry, cell biology, media testing, and buffer performance.
Skills and Competencies:- Technical expertise: In-depth knowledge of QC methods and tools, including ELISA, cell culture assays, mycoplasma testing, sterility testing, and analytical techniques relevant to buffer quality (e.g. spectrophotometry).
- Leadership: Strong management and leadership skills to guide a multidisciplinary QC team handling various products.
- Regulatory knowledge: Solid understanding of regulatory requirements and quality standards (e.g., cGMP, ISO) in relation to assay kits, cell culture media, and detection buffers.
- Problem-solving: Exceptional analytical skills to troubleshoot and resolve complex QC issues and implement corrective actions.
- Communication Skills: Strong verbal and written communication skills, with the ability to effectively present ideas and negotiate with stakeholders.
- Relationship Building: Strong interpersonal skills to build and maintain relationships with key customers, international distributors, and internal teams.
- Project management: Proven ability to manage multiple QC projects simultaneously, ensuring timely delivery of product batches while maintaining high quality standards.
- Attention to detail: High level of accuracy in analyzing test results, reviewing batch records, and ensuring compliance with regulatory and internal requirements.
- Demonstrate expertise in quality systems and process improvement.
Benefits:
- 401k with 4% company match
- Companywide lunches provided quarterly
- Medical/Dental/Vision health insurance plans
- Vacation and paid holidays
BPS Bioscience is an equal opportunity employer, without regard to race, color, religion, age, gender, sexual orientation, disability, or any other characteristic protected by applicable law.
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