YOUR MISSION

The Stability Manager is responsible for managing all aspects of the stability program across all projects and UK and Ireland

sites, including initiating and managing stability studies, protocol development and maintenance, data monitoring, trending and

reporting.

JOB DESCRIPTION

MAJOR ACTIVITIES

Designs, coordinate, and execute stability studies for clinical and commercial gene therapy products according to regulatory

guidelines and company protocols.

Generate stability reports by applying analytical testing expertise to ensure scientific and technical excellence. Utilize

statistical software like JMP to perform rigorous statistical analyses, ensuring robust interpretation of data and adherence to

regulatory standards.

Authors, reviews, revises, and approves SOP's, stability protocols and reports, memo’s, regulatory and specification documents

(as required).

The Stability Manager will also assist with leading the functionality and maintenance of stability related processes and

systems.

Drives continuous improvement activities for the stability programs.
Ensures that the GMP stability program continuously aligns with FDA, ICH and other international agencies.
Manages Quality Systems records for QC Stability- creates, assesses, reviews Deviations, Change Controls, CAPA's and other

applicable stability-related investigations and events.

Guide and work with others to identify opportunities for continuous improvement and implement/maintain solutions.
Provide strong teamwork in establishing a quality culture and shared accountability. Ensure GMP compliance is built into the

design and implementation of processes and systems, including tracking metrics to monitor and improve performance.

Responsible for ensuring that own work and that of the team complies with GMP, Data Integrity and Good Documentation Practice

(GDP) and is undertaken in accordance with applicable procedures

Responsible for ensuring that own training and that of the team is undertaken in a timely and GMP compliant manner before the

task is undertaken.

Responsible for ensuring that any GMP documentation e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs &

audit/inspection actions, within own area of responsibility, is closed timely and in a RFT state.

JOB BACKGROUND

5 years of relevant industry experience in Pharma / Biotech industry required.
Strong understanding of gene therapy stability principles, including degradation pathways, accelerated stability testing, and

shelf-life determination.

Proven experience in managing staff.
Demonstrated proficiency and expertise in various analytical methodologies, particularly in the context of stability testing

and assessment of biologics or gene therapy.

Solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to stability study

design, expiry dating, and analytical method qualification/validation for biologics and gene therapy.

Solid understanding and hands-on experience of applying basic statistical tools for stability data trending and rate analysis

to support retest period/ shelf-life proposals.

Attention to detail and excellent skills in record keeping / documentation.
Experience in IND, NDA and BLA submission is highly preferred.
Strong interpersonal skills; ability to communicate effectively both verbally and in written formats.
Solid understanding of product development activities in biotech/drug/gene therapy development, including key

interdependencies, and knowledge of proven development strategies and tactics.

To travel to other Meira sites when required.

Role

QC Stability Manager

Tags for this job

Similar Jobs

QC Analytical Scientist

MeiraGTx•London

YOUR MISSION The QC Analytical Scientist is responsible for the testing of gene therapy products and associated materials used for manufacturing to EU and FDA GMP requirements. JOB DESCRIPTION MAJOR ACTIVITIES * The testing of gene therapy products in accordance with product specifications to ensure all testing is completed within the required timelines in alignment with the production schedule. * Support testing requirements for the management of the facility including support of the environmental monitoring schedule. * Operation and maintenance of laboratory equipment ensuring all equipment is calibrated and suitable for use in alignment with the test schedule. * Record of out of specifications, non-conformances, investigations, analysis and implementation of corrective action(s) as applicable. * Assistance with the development and updating of SOPs and laboratory documentation. * Part of the Quality Control team, maintain the flow of information, ensuring appropriate communications are passed and information folders are maintained with most recent version/communication. * Ensure all training is undertaken in a timely manner as required to perform required activities. Support any training activities of other employees where required. * Maintain QC facilities to meet GMP requirements, conduct necessary checks to support any health authority, customer/stakeholder site visits. * Support with maintaining the Quality Management System and controlling of documents and assuring the data integrity of all data produced. * Support any external or internal audits where required. * Support with all reasonable managerial requests and ad-hoc tasks. * Work in a team manner with Production personnel. Additional Activities * Assist in the introduction of new analytical methodology for testing gene therapy products. KEY PERFORMANCE INDICATORS * All testing performed meets QC KPI requirements. * Internal quality control audits. * Plan, manage and record training effectively. KEY JOB COMPETENCIES * QC testing of products to GMP requirements. * Maintenance of Laboratories to GMP standards. * Analytical - Synthesizes complex or diverse information; collects and researches data and uses intuition and experience to compliment data. * Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyses information skilfully; develops alternative solutions and works well in group problem solving situations. * Leadership - exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others and accepts feedback from others. * Cost Consciousness - works within approved budget; develops and implements cost saving measures. * Motivation - achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence. * Planning/Organizing - prioritizes and plans work activities; uses time efficiently. * Professionalism - approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments. * Quality Management - looks for ways to improve and promote quality; demonstrates accuracy and thoroughness. * Oral Communication - speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings. * Written Communication - writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information. * Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures. * Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken. * Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a RFT state. JOB RESPONSIBILITIES * Compliance with GMP. JOB BACKGROUND * Degree in Human Health or Sciences or equivalent relevant work experience in the pharmaceutical or other similar regulated industry (i.e. biologics,). * Demonstrate knowledge/experience of a GMP environment and quality control within a pharmaceutical or other regulated industry. * Proficiency in a body of information required for the job e.g. knowledge of EU and FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. * Proficiency in IT, Microsoft Office software (Word, Excel and PowerPoint) preferred.

Deadline: Aug 16Posted: Jul 17

Associate Director, Analytical Development & QC

Relay Therapeutics•Cambridge, MA

Job Description: Your Role: * You will lead and drive strategy for analytical method development and phase-appropriate method validation/transfer activities supporting full characterization of small molecule NCEs, from early development through late-stage/commercial readiness. * Own the analytical strategy for drug substance programs at CDMOs, directing method development, validation, and troubleshooting to enable characterization, release, and stability testing of Relay clinical candidates. * Lead the evaluation and introduction of modern analytical technologies, setting direction for how new techniques are incorporated into method development workflows across programs. * Provide senior-level review and approval of method transfer/validation protocols, data sets, and reports, ensuring scientific rigor and regulatory readiness. * Hold accountability for QC testing oversight across analytical testing labs and DS manufacturing sites, including vendor performance and quality of deliverables. * Review and approve method qualification protocols and reports at external laboratories, serving as the final scientific authority on method suitability. * Direct the review and QC of raw data from third parties supporting batch release and stability; lead data trending efforts, proactively flag risks to the team, and drive resolution of issues. * Manage a portfolio of concurrent projects, prioritizing resources and timelines across programs in a fast-paced, evolving environment. * Serve as a cross-functional leader, partnering with CMC, Quality Assurance, and Regulatory Affairs to shape regulatory and development strategy, and representing Analytical Development in cross-functional and external-facing forums. Your Background: * Ph.D. in Analytical Chemistry, Biotechnology, or a related discipline with 8+ years of relevant industry experience (or MS with 10+ years, or BS with 12+ years) in small molecule pharmaceutical analytical development. * Demonstrated expertise leading analytical method development, validation, troubleshooting, and quality control programs, including experience directing work performed at external CMOs/CROs. * Deep, hands-on analytical knowledge and technical authority in small molecule analytical methods for drug substance and solid-state characterization. * Strong working expertise across analytical instrumentation including HPLC, GC, KF titration, XRPD, ICP-MS, UV, and solid-state characterization techniques, with the judgment to guide method selection and troubleshooting strategy. * A confident, articulate communicator and cross-functional influencer, capable of representing Analytical Development with contract laboratories, manufacturing partners, and internal leadership. * Proven ability to lead through ambiguity and shifting priorities in a fast-paced environment, balancing multiple high-visibility programs against firm timelines. * Previous experience filing or working on IND and/or CTA filings is a plus. * Strong command of regulatory and analytical guidelines, including cGMPs, ICH, FDA, USP, and other global regulatory requirements, with experience applying this knowledge to shape submission strategy. Estimated Salary Range: [$140,000-$200,000]. The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate’s education, experience, skills and location. #BP1 About Relay Therapeutics Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process. Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you’re excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us!

Deadline: Aug 22Posted: Jul 22

Other

Head, POS Hardware & Repair

Moniepoint•Lagos

Who We Are Moniepoint is Africa's all-in-one financial ecosystem, empowering businesses and their customers with seamless payment, banking, credit, and management tools. In 2023, we processed $182 billion and are Nigeria’s largest merchant acquirer. What We Do At Moniepoint, we are a customer-focused community, dedicated to crafting solutions that redefine our industry. We have several products that provide essential services for businesses, such as credit, overdrafts, etc. We leverage artificial intelligence and data to make our decisions but also have the technology and data-driven best practices used to support our businesses. Curious about what makes Moniepoint an incredible place to work? Check out posts on how we cultivate a culture of innovation, teamwork, and growth. About the Role The Head of POS Hardware & Repair is a strategic technical leadership role focused on ensuring the quality, reliability, and serviceability of all Point of Sale (POS) hardware devices used by the company. This individual acts as the primary technical liaison with POS manufacturers, driving design and component selection to meet rigorous company standards and optimize for easy, cost-effective repair in the Nigerian market. This role directly manages and oversees all POS device repair operations. KEY RESPONSIBILITIES 1. POS HARDWARE QUALITY ASSURANCE & DESIGN STRATEGY * Manufacturer Liaison: Serve as the main technical point of contact with all POS hardware manufacturers. * Design Adherence & Vetting: Rigorously review and audit manufacturer design specifications and component lists to ensure strict adherence to the company's recommended designs, quality standards, and use of robust, reliable components. * Design for Serviceability (DFS): Proactively recommend specific design updates, modifications, and material changes to manufacturers that simplify repair processes, reduce component costs, and improve the Mean Time to Repair (MTTR). * Component Reliability: Evaluate and approve critical hardware components (e.g., batteries, screens, printers) based on reliability data, failure rates, and long-term supply stability. * Failure Analysis: Partner with Engineering/Data teams to conduct root cause analysis (RCA) on recurring hardware failures and translate these findings into concrete, mandatory design improvements for manufacturers. 2. LOCAL MARKET ADAPTATION & RELEVANCE (NIGERIA FOCUS) * Market Insight: Maintain deep, continuous awareness of the operational reality, environmental conditions, and logistical challenges specific to the Nigerian market. * Design Recommendation: Translate local environmental and usage data (e.g., power fluctuations, dust, handling) into practical design requirements (e.g., ruggedization, better component protection) for manufacturers. * Spare Part Management: Define and validate the list of required spare parts that must be provided by the manufacturer, ensuring they are the most critical and highest-failure-rate components suitable for the local repair environment. 3. POS REPAIR OPERATIONS OVERSIGHT * Repair Strategy: Define the strategy and operational model for all POS device repair operations, including internal repair centers and outsourced service providers. * Performance Management: Manage and monitor the performance of the repair function against key metrics, focusing intensely on reducing Mean Time to Repair (MTTR) and improving the First-Time Fix Rate. * Process Standardization: Develop and enforce standardized repair procedures, diagnostics, and quality control (QC) protocols to ensure consistent, high-quality repair outputs across all channels. * Tooling & Training: Approve and oversee the technical training and certification of all repair technicians and ensure they have the necessary diagnostic equipment and tools. * Repair Data Reporting: Establish a robust reporting structure for tracking component failure rates, repair costs, and inventory of parts used in repair to inform future design changes. QUALIFICATIONS AND EXPERIENCE * Education: Bachelor’s degree in Electrical Engineering, Electronics Engineering, Mechatronics, or a closely related technical field. * Experience: Minimum of 8+ years of experience in hardware engineering, quality control, technical operations, or product service management, with at least 3 years in a leadership role. * Technical Expertise: Deep, hands-on knowledge of embedded systems, circuit board components, electronic repair methodologies, and diagnostic tools, particularly within the POS, terminal, or embedded payment device space. * Manufacturer Management: Proven track record of successfully managing technical relationships with international hardware manufacturers, including design review and quality auditing processes. * Operational Acumen: Experience managing complex repair/service operations, with a strong focus on KPIs like MTTR, Cost-of-Repair, and Failure Rate analysis. * Market Knowledge (Highly Preferred): Direct experience with hardware deployment and service operations in the Nigerian or similar emerging markets, understanding the unique environmental and logistical constraints. * Soft Skills: Exceptional negotiation, technical communication, and analytical skills. What we can offer you * Culture: We put our people first and prioritize the well-being of every team member. We’ve built a company where all opinions carry weight and where all voices are heard. We value and respect each other and always look out for one another. Above all, we are human. * Learning: We have a learning and development-focused environment with an emphasis on knowledge sharing, training, and regular internal technical talks. * Compensation: You’ll receive an attractive salary, pension, health insurance, an annual bonus, plus other benefits. What to expect in the hiring process * A preliminary phone call with the recruiter * An interview with the hiring team. * An interview with a member of our executive team. Moniepoint Inc. is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees and candidates.

Deadline: Aug 17Posted: Jun 29

Repairs and Insurance