Manager of Regulatory Affairs

The Manager of Regulatory Affairs will execute all regulatory activities on a global basis. The incumbent will provide planning and leadership to the regulatory department, ensuring that appropriate structures, systems, competencies and values are developed. The incumbent will oversee the preparation and submission of State, Federal and international registrations and will operate as a liaison between regulatory agencies (EPA, state, etc.) and the corporation.  The incumbent will provide all necessary communication and will travel to conduct in-person meetings.  The incumbent will provide regulatory support and assistance related to FIFRA registrations to customers, distributors, vendors and the general public and will actively participate on professional committees and analyze industry correspondence with follow-up and discussion with internal colleagues and other industry participants on relevant issues. The incumbent will manage assigned regulatory compliance personnel and assist in developing and maintaining systems to comply with regulatory and customer (quality system) requirements. The incumbent will resolve and facilitate resolution of problems including identifying causes to prevent reoccurrence and will ensure that all adverse events are dealt with in accordance with company SOPS. The incumbent will review and approve all GLP studies and protocols and will assist in soliciting outside work and funding to help support the research facility. The incumbent will be an active participant on project teams including new product development opportunities, custom solutions opportunities, international registration priorities, due diligence for potential new business or products and will participate in management meetings. The incumbent will oversee and provide direction to staff for draft labeling of new registrations and will oversee changes to existing labels as required by new regulations. The incumbent will coordinate with product management team to draft and prepare labeling for printing. The incumbent will direct and assist regulatory personnel with proper preparation maintenance and implement training so they understand compliance. The incumbent will direct and oversee the maintenance of regulatory files and records including a status report of international registrations.  The incumbent will conduct meetings with the international sales team and develop and manage the budget for the regulatory department.

Qualifications include a science based Bachelor’s degree from a four-year college or university and 5+ years of related experience.

To be immediately considered for this opportunity, please  Apply Now.

Global Development and Operations Executive Director

The incumbent will provide high level direction to Global Development and Operations, including establishing key goals for operational efficiency and excellence, and continuous improvement targets. Position responsibilities include coaching and mentoring direct reports and other staff to facilitate colleague development and succession planning. The successful candidate will lead efforts to practice objective colleague performance assessment and effective performance management, will participate on the leadership team and contribute to creating the strategic direction of the research and development organization. The incumbent will ensure robust planning, execution, analysis and reporting of clinical studies for Biologicals, Pharmaceuticals and Biopharmaceuticals to support the timely progression of global registration plans and achievement of budget targets. The incumbent will seek opportunities to collaborate with commercial partners to provide insights into facilities, systems and processes.

The incumbent will provide leadership for a large team of people that supports the execution of clinical studies, including study site selection, initiation and monitoring; data capture, management and archival; report preparation; document systems design and maintenance; and regulatory dossier production.

Qualifications include advanced degree (DVM/VMD or PhD) with 10+ years of experience in veterinary drug and biologicals development. Candidates without advanced degrees, but with 15+ years of relevant experience may also be considered. The successful candidate will have experience in Clinical Study Design and Execution, Biometrics, Data Management, Document Systems and Regulatory Submission Publishing. Other qualifications include general veterinary knowledge across livestock and companion animals, a good understanding of the U.S. commercial veterinary market and familiarity with major global veterinary markets, excellent oral and written communication skills, strong interpersonal skills, including negotiating and problem solving, experience in registering veterinary products, including biologicals and pharmaceuticals and will be experienced in veterinary clinical development with familiarity with global regulatory processes.

To be immediately considered for this opportunity, please  Apply Now.

Scientific & Business Assessment Manager

(This could be 1 role or 2 roles). This is a new role that combines both business development and a scientific approach for evaluating ingredients and product sourcing.  The incumbent will assist in the development of new products for the Veterinary Division, including rationale, budget and project timeline and will assist in the development of product improvements and new product ideas. The incumbent will provide input and recommendations for business development proposals, prepare scientific abstracts and manuscripts for publication, including assisting in selection of relevant scientific journals, monitor new developments and current status of veterinary supplements and pharmaceutical clinical research projects, studies and trends. The incumbent will work with Veterinary Technical Services clinical study projects and communicate effectively with other departments within the organization.

Qualifications include a Veterinary Medicine degree along with knowledge of scientific principles and practices, excellent writing skills, interpersonal and communication skills, organizational skills, and computer literacy. Knowledge of MS Project is required. Three to six years of industry experience is preferred. Business development experience is also preferred.

To be immediately considered for this opportunity, please  Apply Now.

Manager/Associate Director Parasitology Research and Development

The incumbent will support the design and execution of research and development studies and projects in parasitology. The incumbent will provide expertise within and across functions in the field of parasitology, participate in research and development project teams to license veterinary antiparasitics, plan, design and lead clinical studies and/or clinical programs for licensure of antiparasitic products. This may include consideration of appropriate study design, protocol generation, study monitoring, data collection, data analysis and interpretation, as well as authoring and review of final reports. The incumbent will ensure the collection and maintenance of accurate documentation to meet regulatory requirements for product licensure and to contribute to generation of dossiers for submission to regulatory agencies to support product licensure. The incumbent will support development, progression and implementation of the parasitology product portfolio strategy, contribute to the identification of potential new research, development and market support opportunities in the field of parasitology, support regional efforts to promote the licensing of products and/or technologies and publish and present results to facilitate the organization’s objectives. The successful applicant, depending on experience, may be asked to lead parasitology projects and contribute to the parasitology product portfolio strategy.

Qualifications include a veterinary degree (DVM or VMD), advanced training, PhD or experience in veterinary parasitology, experience of design and execution of parasitology clinical research and/or development studies, excellent communication and interpersonal skills, ability to work both as a member of a team and also independently, able to work under pressure to meet multiple project timelines skilled technical writer and good computer and technology skills. This position could require up to 10% travel.  Desired skills include previous experience in the Animal Health pharmaceutical/vaccine industry or of parasitology research in an academic or commercial environment, experience as a project leader, particularly for veterinary antiparasitic projects, understanding of the regulatory requirements for successful licensure of veterinary products, understanding and/or experience of electronic data capture (EDC) tools, ability to understand, influence and motivate colleagues in a matrix organization. Good computer and technology skills are required.

To be immediately considered for this exciting opportunity, please Apply Now.

Director of Bovine Biologics Research

This individual will contribute to the strategy, planning and advancement of the bovine biologics portfolio worldwide. The incumbent will lead a team of scientists to progress the bovine biologics portfolio and will help define the strategy and position the group to lead in the bovine biologics sector. The successful candidate will work in a collaborative research environment.

Qualifications: We are seeking someone with a proven track record of discovery and development of novel cattle vaccines who will contribute to the strategy, planning and advancement of the bovine biologics portfolio worldwide. The successful candidate will have an understanding of the beef and dairy cattle industry and the impact of existing and emerging infectious diseases and the host-pathogen interactions that occur in order to successfully deliver on the portfolio.  Other qualifications include a DVM and PhD preferably in a bovine infectious disease area with 10 years of experience in the research development and licensing of biologics.  Industry experience with bovine biologics  is required.

To be immediately considered for this opportunity, please  Apply Now.

Director of Research and Development

We are looking for a geneticist for a global role for an international organization. The incumbent will lead existing breeding programs and develop new research projects according to the needs of customers all over the world.  The incumbent will become the trendsetter for future quality and features of food, will coordinate and consolidate the activities of research farms located in different regions of the world, manage a division of highly experienced employees on farms and in the headquarters, supervise the documentation and updating of processes and procedures related to the capture of phenotypic data and genetic utilization, large scale data processing and data analysis, be kept abreast in the areas of responsibility by establishing a network of industry and academia contacts, studying literature and attending scientific meetings, provide scientific advice to the technical service department to further enhance and maintain the performance of the birds.  The responsibilities include continuous development and improvement of the breeding stocks to increase rates of genetic gain for all traits under evaluation, support in the development of marketing material that highlight the competitive advantage of the company’s products.

Qualifications include a degree in agriculture or veterinary medicine, PhD in animal breeding/genetics preferred. Applications from candidates with similar degrees will also be considered.  Distinct expertise in the area of animal or crop breeding, experience in bioinformatics data analysis is desirable, strong communication skills, ability to travel internationally up to 25%, Sound knowledge of MS Office.  We are looking for a self-assured individual who is responsible and convincing.

To be immediately considered for this opportunity, please  Apply Now.

Research Chemist

This is an opportunity for a research chemist who has extensive research and development experience in novel pesticide formulas.

Qualifications include a Bachelor’s or Master’s degree from a college or university and four+  years of pesticide development, or a Ph.D with one or more years of pesticide development experience. We will also consider a Ph. D with one or more years of industry-related experience. Candidate must have served a key role in development of at least one unique product from concept to completion or which has generated an invention disclosure form or similar status up to and including successful patent registration.  Special preference will be given to candidates with practical experience formulating disinfectants.

To be immediately considered for this opportunity, please  Apply Now.

Manufacturing Associate

The Manufacturing Associate will serve as CMO Project Manager for prescription drug product candidates and non-prescription products . The successful candidate will be an experienced CMO project manager and critical thinker who will serve as a key contributor at an animal healthcare company. The successful candidate will manage all aspects of CMO relationships, including sourcing CMOs, preparing RFPs, negotiating terms and determining budgets. The incumbent will manage development, optimization and production of formulated materials, adhere to strict timelines and partner closely with regulatory.

Qualifications include a minimum of 3-5 years’ experience managing CMO relationships, including sourcing CMO’s negotiating terms and managing development, optimization and production of formulated materials, 2+ years of experience managing multi-million dollar budgets, PhD or MS degree with 2-4 years of experience (or a BS degree with 3-5 years’ experience) in formulation science from an accredited institution with strong emphasis in one or more of the following disciplines: biotechnology, biology, pharmaceutics, medicinal chemistry, chemical engineering, polymer science or pharmacokinetics. Other requirements include hands on  manufacturing experience at all levels (lab, pilot, full commercial(, proven understanding of cGMP, breadth and depth of understanding of the pharmaceutical/animal health industry (API, DP, packaged product formats) with an emphasis on API experience, working knowledge of CMC Guidance for veterinary products, regular travel to domestic and global CMO’s, experience working independently and in multi-disciplinary, geographically dispersed teams, strong analytical and problem solving skills, ability to learn quickly and adapt to change, good communicator, ability to travel in the US as well as travel internationally and be able to overcome obstacles.

To be immediately considered for this opportunity, please  Apply Now.