Rx Group is recruiting for a clinical stage cell therapy biotech, based in Maryland, who are searching for a Director, QC Microbiology, overseeing the microbiology program supporting lot release and environmental monitoring. Demonstrating adept leadership and collaborative skills, they will spearhead the expansion of the QC Microbiology team.

Principal Duties/Responsibilities:

• Lead and oversee the microbiology program supporting lot release and environmental monitoring.
• Drive the growth of the QC Microbiology team.
• Serve as the principal QC liaison with site manufacturing operations teams for microbiological routine testing and support.
• Responsible for recruiting, developing, and managing the Microbiology labs.
• Manage budgets for capital and operational costs of the QC Microbiology teams.
• Provide hands-on management and supervision of daily operations in the microbiology laboratory, including sample processing, data analysis, and reporting.
• Introduce and implement innovative technologies, methods, and processes for microbial analysis.
• Ensure all laboratory activities comply with relevant regulations and guidelines.
• Offer scientific leadership and technical expertise to the laboratory team.
• Mentor and manage a team of microbiologists and technicians, including recruitment, training, and performance evaluation.
• Collaborate with other departments and external partners on applicable projects.
• Oversee maintenance and calibration of laboratory equipment and instrumentation.
• Prepare reports and presentations for senior management and external stakeholders.
• Ensure compliance with company policies, evolving Health Authority regulations, and expectations for the QC Microbiology Team.
• Support QC planning and scheduling activities as necessary.

Qualifications:

• Hold a Ph.D. with post-graduate experience in Microbiology, along with a minimum of 10 years' experience in Microbiology-focused projects within the Pharmaceutical Industry.
• Possess a deep understanding and experience of GMP principles.
• Exhibit strong leadership skills in motivating and developing departmental staff.
• Proven success in team environments and adeptness in managing professionals through evolving business needs.
• Ability to influence cross-functional work in a matrix environment, from startup to commercial manufacture.
• Experience in technical transfer of new products and product changeover, including interactions with regulatory agencies.
• Extensive management experience of increasing responsibility.
• Desired experience in building and growing organizations.
• Comprehensive knowledge of US and EMA GMP regulations and guidance.
• Proficiency in leadership, interpersonal, communication, and motivation skills.
• Understanding of test methods and instrumentation associated with biopharmaceutical processes, including microbiological release testing.
• Excellent written and verbal communication skills for conveying complex scientific information.
• Strong planning and organizing abilities to manage resources against timelines and project commitments, adapting to changing priorities and dynamic work environments.

Please contact Hemish Ilangaratne at h.ilangaratne@rx-group.io or apply directly via the website for further information. 

Rx Group is recruiting an Executive Director of Quality Assurance for a clinical stage cell therapy biotech in California. Reporting directly to the Senior Vice President of Quality, the Executive Director of Quality will play a pivotal role in ensuring compliance with regulatory requirements, driving continuous improvement initiatives, and maintaining a culture of quality excellence throughout the organization.

Key Responsibilities:

• Develop and implement the overall quality strategy in alignment with company goals and regulatory requirements.
• Provide strategic direction and leadership to the quality assurance and control teams.
• Ensure compliance with relevant regulations and guidelines, including FDA, EMA, and other international regulatory authorities.
• Oversee the preparation for regulatory inspections and support regulatory submissions as needed.
• Establish and maintain robust quality systems to support late-phase clinical development activities.
• Monitor and evaluate the effectiveness of quality systems and processes, implementing improvements as necessary.
• Develop and maintain quality assurance programs to ensure product safety, efficacy, and compliance with specifications.
• Conduct internal audits and oversee vendor audits to assess compliance with quality standards.
• Identify and assess quality risks associated with cell therapy manufacturing and clinical development activities.
• Develop risk mitigation strategies and ensure their effective implementation.
• Recruit, mentor, and develop a high-performing quality team capable of supporting the company's growth and objectives.
• Provide coaching and guidance to team members to foster a culture of continuous learning and improvement.

Qualifications:

• Bachelor's degree in a relevant scientific discipline; advanced degree preferred.
• Minimum of 10 years of experience in quality assurance and control within the biopharmaceutical industry, with specific experience in cell therapy highly desirable.
• In-depth knowledge of FDA and international regulatory requirements for late-phase clinical development.
• Proven track record of leading successful quality initiatives and driving continuous improvement.
• Strong leadership and communication skills, with the ability to collaborate effectively across functions and levels of the organization.

This is a full-time, hybrid position based in California. The Executive Director of Quality will have the opportunity to make a meaningful impact on the development and commercialization of innovative cell therapies while working in a dynamic and collaborative environment. If you are passionate about quality and driven to make a difference in patients' lives, we encourage you to apply directly or reach out to Hemish Ilangaratne at h.ilangaratne@rx-group.io.

Rx Group is recruiting for a Head of QC to join a late phase gene therapy biotech for an on-site position in Florida.

Key Responsibilities:

• Leadership: Provide strategic direction and leadership to the QC team, fostering a culture of excellence, collaboration, and continuous improvement.
• Team Management: Recruit, develop, and mentor a high-performing QC team, ensuring adequate staffing and training to support departmental objectives.
• QC Operations: Oversee all QC activities related to Microbiology and Analytical testing, including method development, validation, and transfer.
• Compliance: Ensure adherence to regulatory requirements and industry standards (e.g., FDA, EMA, ICH) in QC operations, documentation, and reporting.
• Quality Systems: Establish and maintain robust quality systems to support QC operations, including SOPs, protocols, specifications, and investigations.
• Technology Transfer: Lead the transfer of analytical methods and technologies from development to QC, ensuring seamless integration and implementation.
• Risk Management: Identify and mitigate risks related to QC operations, ensuring product quality and patient safety throughout the product lifecycle.
• Cross-Functional Collaboration: Collaborate closely with other departments, including Manufacturing, Quality Assurance (QA), Regulatory Affairs, and R&D, to support overall business objectives and project timelines.
• Continuous Improvement: Drive continuous improvement initiatives within the QC function, implementing best practices and innovative technologies to enhance efficiency and effectiveness.
• Communication: Communicate QC strategy, progress, and issues effectively to senior management and key stakeholders, providing regular updates and recommendations.

Qualifications:

• Bachelor's degree in a relevant scientific discipline (e.g., Biology, Chemistry, Microbiology); advanced degree (e.g., Master's or Ph.D.) preferred.
• Minimum of 8-10 years of experience in pharmaceutical or biotech QC, with at least 5 years in a QC leadership role.
• Extensive knowledge of QC principles, methodologies, and regulatory requirements applicable to gene therapy products.
• Strong technical expertise in Microbiology and Analytical testing techniques, including PCR, ELISA, HPLC, and other relevant assays.
• Experience with quality systems (e.g., GMP, GLP) and regulatory inspections (e.g., FDA, EMA).
• Proven track record of successfully managing and developing high-performing QC teams in a fast-paced environment.
• Excellent leadership, communication, and problem-solving skills, with the ability to influence and collaborate effectively across functions.
• Detail-oriented mindset with a strong commitment to quality, compliance, and patient safety.

Please apply directly or contact Hemish Ilangaratne at h.ilangaratne@rx-group.io for further information.

Rx Group is recruiting for an Associate Director, Quality Control Microbiology for a clinical stage gene therapy biotech in Florida. The role is an on-site position.

The Associate Director, QC Microbiology will be responsible for oversight of all activities in the Quality Control and Microbiology laboratories. This includes oversight of projects both internally to the company as well as with external partners and contractors. In collaboration with manufacturing, they will set requirements for raw materials from suppliers. Additionally, they will establish metrics for assay performance.

Duties and Responsibilities

• Manage Quality Control Microbiology staff including recruiting, onboarding, and performance management.
• Focus on employee engagement by creating a culture of transparent communication, teamwork, and empowerment with a strong focus on career development for Quality Control Microbiology staff.
• Develop short-term and long-term goals for Quality Control Microbiology team in alignment with project goals and broader organizational goals; monitor progress against goals.
• Oversight for maintaining complex analytical instruments, using knowledge and experience to appropriately respond to performance degradation or malfunctions, scheduling, monitoring, and interfacing with external personnel as necessary.
• Ensure all project team deliverables are met for outsourced Quality Control Microbiology work including lot release, stability testing, method validation/transfer/verification, reference standard qualification and analytical comparability.
• Continue to build a strong interface to Analytical Development to ensure seamless transfer of analytical methods into QC labs and subsequent phase appropriate validation of such methods.
• Establish, own, and lead a global community of practice, using the community to align and standardize microbiology best practices.
• Establish a program of periodic audits of the site-based microbiology processes such that processes are assessed for compliance to internal and external standards, that areas for improvement are identified in a timely manner, and real time coaching is provided to staff and risks appropriately raised.
• Interface with and build strong collaborative relationships with external stakeholders (CMOs or contract labs) and internal stakeholders including development (upstream, downstream and formulation), CMO and Project Management, Regulatory CMC, and Quality Assurance
• Independently resolve technical issues; effectively lead teams with internal and external SMEs to solve issues with broad scope and/or high complexity.
• Escalate challenges to management; develop constructive proposals and implement solutions for resolution of challenges.
• Ensure compliance within QC by monitoring test methods, SOPs, and QC analytical data to cGMPs, pharmacopeial and regulatory requirements.
• As needed review and approve deviations, laboratory investigations and evaluate proposed analytical change requests.
• Oversee Quality Control Microbiology contributions to regulatory flings including review of regulatory applications (clinical and marketing applications), review of responses to information requests, and review of briefing documents; develop and implement plans to address gaps based on regulatory feedback or country specific testing requirements.
• Lead efforts to harmonize Quality Control Microbiology business processes and SOPs with other company functional areas; ensure SOPs are compliant with applicable regulations while maintaining flexibility and being phase appropriate.
• Provide input on budget and resources planning.
• Manage Quality Control Microbiology staff including recruiting, onboarding, and performance management.
• Focus on employee engagement by creating a culture of transparent communication, teamwork, and empowerment with a strong focus on career development for Quality Control Microbiology staff.

Educational Qualifications

• B.S. degree in Microbiology
• Advanced degree in biochemistry, chemistry, analytical chemistry, biology, or related field preferred.

Additional Qualifications

• At least eight (8) years’ Quality Control Microbiology experience, (10-12 preferred) in a GLP/GMP environment, preferable in biotechnology company.
• 5+ years of people management experience with proficiency in establishing objectives, monitoring performance, providing feedback, and developing staff.
• In-depth understanding of GLP and GMP (drugs and biologics) regulations, guidance documents, systems, processes, and procedures
• Great attention to detail
• Strong interpersonal skills
• Strong prioritization, organizational and negotiating skills.
• Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management.
• Solid time management skills and ability to handle multiple tasks and deliver high quality results within set timelines.

Please apply directly for this role or contact Hemish Ilangaratne at h.ilangaratne@rx-group.io if interested.

Rx Group is recruiting a quality director, site head for a clinical-stage gene therapy biotech based in Florida.

Job Summary:

The successful candidate will play a pivotal role in ensuring the highest standards of quality, compliance, and regulatory adherence throughout clinical-stage gene therapy operations. Reporting to the Vice President of Quality, the Site Quality Assurance Director will be responsible for overseeing all aspects of quality assurance activities, driving continuous improvement initiatives, and fostering a culture of quality excellence within the organization.

Key Responsibilities:

• Leadership: Provide strategic leadership and direction to the site quality assurance team, fostering a collaborative and high-performance culture focused on quality and compliance.
• Quality Management Systems (QMS): Develop, implement, and maintain robust quality management systems in accordance with applicable regulations and industry standards (e.g., FDA, EMA, ICH).
• Regulatory Compliance: Ensure compliance with relevant regulatory requirements, guidelines, and standards for clinical-stage gene therapy products, including GxP, ICH, and cGMP.
• Audits and Inspections: Plan and coordinate internal and external audits, inspections, and assessments, driving timely resolution of findings and implementation of corrective/preventive actions.
• Document Control: Oversee document control processes, including document creation, review, approval, distribution, and retention, to ensure accuracy, completeness, and compliance.
• Training and Development: Implement training programs to ensure staff competency in quality and regulatory requirements, promoting a culture of continuous learning and development.
• Risk Management: Lead risk assessment activities to identify, evaluate, and mitigate quality and compliance risks associated with gene therapy manufacturing and testing processes.
• Supplier Quality Management: Collaborate with cross-functional teams to establish and maintain robust supplier quality management programs, including supplier qualification, audits, and performance monitoring.
• Continuous Improvement: Drive continuous improvement initiatives to enhance quality systems, processes, and procedures, leveraging data-driven approaches and best practices.
• Communication: Serve as the primary point of contact for quality assurance-related matters, providing regular updates, reports, and presentations to senior management and stakeholders.

Qualifications:

• Bachelor's degree in life sciences, engineering, or a related field; advanced degree preferred.
• Minimum of 8-10 years of experience in quality assurance roles within the Pharma & Biotech industry, with at least 5 years in a director level position.
• In-depth knowledge of global regulatory requirements and guidelines for gene therapy products highly beneficial.
• Strong understanding of quality management systems (QMS), quality risk management principles, and Good Manufacturing Practices (GMP).
• Proven track record of successfully leading and managing quality assurance teams in biotech OR CDMO's.
• Excellent communication, interpersonal, and leadership skills, with the ability to influence and collaborate effectively across functions and levels of the organization.
• Results-oriented mindset with a focus on continuous improvement and problem-solving.

Please apply directly or contact Hemish Ilangaratne at h.ilangaratne@rx-group.io for further information.

Job Title:

CMC Functional Head (VP/SVP level) - Consultant or FTE - Remote.

Job Description:

Rx Group is recruiting for a dynamic and versatile leader to fill the role of CMC Functional Head at a Boston based, start-up biotech organization with multiple pre-clinical programs.

As a key member of the leadership team, you will play a pivotal role in navigating the complexities of preclinical and clinical development, managing external suppliers, and driving projects from gap analysis to execution. The ideal candidate will have a strong Analytical, Product Development and CMC background with a proven track record of success in advancing complex biologics through to regulatory milestones, possess expertise in CMC strategy and execution, and excel in CDMO and CMO management. The organization aims to deliver multiple IND's in the next two-three years

Responsibilities:

• Lead the CMC function and contribute to the strategic direction of the company's pipeline development.
• Drive project management activities from inception to completion, ensuring timelines, budget, and quality standards are met.
• Oversee the management of external suppliers, including major CDMOs/CMOs, to ensure efficient and effective collaboration.
• Make strategic decisions regarding greenfield manufacturing and establish strong relationships with suppliers globally.
• Collaborate with cross-functional teams to integrate CMC strategies into overall development plans.
• Provide leadership and mentorship to CMC team members, fostering a culture of excellence and innovation.
• Represent the company in interactions with regulatory agencies and external partners.

Next Steps:

If you'd like to learn more, please apply directly or reach out to Hemish Ilangaratne at h.ilangaratne@rx-group.io.

Rx Group are supporting a global pharmaceutical organisation, with a QC Director for an on-site position in Indiana. As the QC Director, you will play a crucial role in ensuring the quality and safety of our pharmaceutical products through effective leadership, strategic planning, and in-depth expertise in microbiology.

Role and Responsibilities

• Develop and execute the QC strategy aligned with business goals and regulatory requirements.
• Provide visionary leadership for continuous improvement in quality control processes.
• Stay abreast of global regulatory changes and ensure departmental compliance.
• Direct and oversee microbiological testing, ensuring accurate and timely results.
• Act as the primary contact for microbiology-related matters, providing expertise.
• Establish and maintain robust quality control systems, including SOPs.
• Implement and monitor key performance indicators (KPIs) for process improvement.
• Recruit, train, and manage a skilled QC team, fostering collaboration and learning.
• Collaborate with cross-functional teams to integrate QC processes across the product life cycle.
• Manage relationships with external vendors and CROs involved in QC testing.
• Oversee validation and qualification of QC testing methods, equipment, and processes.
• Drive continuous improvement initiatives and conduct regular reviews for efficiency.

Experience and Qualifications

• Bachelor's, Master’s, or Ph.D. degree in Microbiology, Biology, or related field.
• Minimum of 10 years of experience in Quality Control leadership roles within the pharmaceutical industry.
• Extensive experience in microbiology with a strong understanding of testing methodologies, microbial identification, and environmental monitoring.
• Proven track record of successful implementation and management of quality systems in compliance with regulatory standards.
• Excellent leadership and communication skills, with the ability to influence and collaborate effectively at all organizational levels.
• Strong problem-solving skills and the ability to make sound decisions under pressure.

Location:

This position is based in Indiana, USA. The role requires on-site presence to oversee QC operations and collaborate with cross-functional teams.