Careers

We are seeking a self- motivated, energetic, and highly detail-oriented CPDO to lead the company’s global product development activities and join the Executive Management team.

This position will be a key C-level role that will work closely with the Board and Executive Management to lead an ambitious product development program in in line with and also with direct impact on the company’s corporate strategy. The successful candidate will have overall responsibility in coordinating internal and external resources to execute the plan.

He/She will also be expected to work closely with, manage and mentor internal scientists and project teams including third parties as well as external contract research organizations and key opinion leaders. Deep subject matter expertise, long standing, relevant expertise and strong leadership, decisive thinking, problem solving and time management skills are essential to manage diverse and complex tasks.

Responsibilities will include, but are not limited to, the following:

• Develop a strategy to bring antibody candidates forward and achieve regulatory approval in the shortest and most cost-effective manner in the USA, Europe and Asia.
• Create and manage a small internal Chemistry, Manufacturing, Control (CMC) program for monoclonal antibody production, fostering excellence in team performance and execution.
• Provide strategic direction and guidance on key CMC deliverables to ensure successful regulatory outcomes.
• Review, endorse, sponsor CMC initiatives and execution plans, including driving selection of third-party organizations, resource allocation, budget management and forecasting.
• Actively support, and encourage a cross functional work environment and focus on the requirements of the product within the Mouse Engineering and Antibody Discovery teams to ensure a smooth transition of preclinical assets into clinical development.
• Review target product profiles and provide guidance likely to maximize drug manufacturability and clinical performance.
• Provide expertise and experience in selection of targets and in driving corporate strategy forward.
• Develop and implement a phase-appropriate manufacturing strategy, with an appreciation of late-stage manufacturing including process characterization and process validation activities.
• Oversee external supply chain including critical raw materials including synthetic DNA vectors for mAb production, cell lines and cell banks.
• Develop and implement the company’s strategy for clinical testing with a view to the different market and ensure this is managed in concert with CMC.
• Organize and manage internal quality and regulatory programs, and external CRO/CMOs to ensure timely and project delivery of manufacturable product.
• Develop and implement comprehensive development activity reports for the Executive Management review and Board reports.
• Review, and/or approve Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed.
• Develop and monitor department goals, objectives, and metrics to ensure alignment with and delivery of corporate objectives.
• Implement and evaluate continuous improvement opportunities.
• Ensure team compliance to GxP documentation requirements and training.
• Monitor international trends in technology, manufacturing, quality and supply; represent the interest of PetMedix in various forums.

Requirements & Education

A PhD or equivalent work experience in Biochemistry, Immunology, Pharmacology or related discipline. The successful candidate must have a minimum of 15 years of drug development in the biotech/pharmaceutical industry, preferably in Animal Health with significant experience in the design and development of monoclonal antibody products. They will also have 10 years, or more, experience managing global functions across multiple time zones and varied cultural work environments. The candidate should have proven experience in working with diverse regulatory agencies from FDA, EMA to USDA and other international agencies and a deep understanding of different paths to approval for biological products in animal health.

Skills/Knowledge

• Experienced in early development as well as late stage/commercial pharmaceutical projects with a strong track record of successful USDA and FDA filings (EMA desirable).
• Proficient in CMC and manufacturing in pharmaceutical industry procedures and regulations.
• Cross functional experience in QA, Regulatory Affairs, R&D are highly desirable.
• Significant experience working in and/or managing outsourcing projects.
• Ability to lead continuous improvement initiatives across the organization.
• Problem-solving and decision-making skills.
• Flexibility and the ability to manage change.
• Strong interpersonal skills and the ability to lead a team.
• Exceptional verbal and written communication skills, and negotiation skills.
• Solid organizational, time management and project management skills.
• Demonstrated ability for analytical and systematic thinking.
• Strong sense of urgency.

Terms

This is full-time role with a competitive salary in line with experience and other benefits such as company share options, private pension plan and health insurance. While the role is global in nature and will have a substantial amount of work to be completed in the USA, it requires regular presence at the company headquarter in Cambridge, UK. However, the incumbent does not necessarily have to live in the UK/Cambridge area.