The Vet Recruiter » Research & Development

Research & Development Scientist

admin — Wed, 01 Feb 2012 05:26:37 +0000

As applied molecular biologist to coordinate, develop, validate and apply techniques such as real time PCR and next generation sequencing to ensure the timely processing and characterization of research and diagnostic/clinical samples. The incumbent will perform analysis on select microbial or host genomes that include real time PCR amplification and Next Generation Sequencing and will utilize and apply data generated from Next Generation Sequencing and real time PCR for both diagnostic and research purposes. The scientist will utilize bioinformatics to provide distinct microbial characterization on processed and archived samples, plan and design and/or conduct/oversee in vitro studies and/or experimental trials, for example, establish schedules and arrange for animal sources (if needed) and arrange for appropriate laboratory resources and consumables, conduct pre trial meetings, participate in vaccination, challenge, necropsy and sample processing, write and review drafts of Laboratory Services diagnostic protocols and reports and recommend and implement new technology. The incumbent will provide training and support during transfer of data and information generated from new technology to other departments, write and review protocols, prepare training materials, provide technical input, oversee preparation of medial, reagents, buffers and glassware used in laboratory tests.

Qualifications include Ph.D. +/-DVM in Molecular Biology or equivalent with 2+ years of experience. Advanced knowledge in molecular biology and microbiology, advanced knowledge in molecular assay development and validation for diagnostic purposes, experience to include real time PCR, next generation sequencing and bioinformatic analysis, experience in microbial genomics and pathogensis, experience in veterinary diagnostics, experience in animal viral and bacterial disease model development. This position requires 10% business travel.To learn more about this exciting opportunity, please Apply Now.

Scientist II

admin — Mon, 30 Jan 2012 20:37:33 +0000

The incumbent will handle the generation and analysis of real time PCR and next generation sequencing data in a diagnostic setting, communicate data and information generated to both internal and external customers, provide functional support to R&D Project Leads, Laboratory Services Manager, Autogenous Laboratory Manager and Scientific Support Director.

Qualifications include a Ph.D +/-DVM in Molecular Biology or equivalent with 2+ years of experience or Masters in Molecular Biology or equivalent with 5+ years of relevant experience. The incumbent should have expertise in the bioinformatic analysis of microbial genomes and potentially host transcriptomes. This analysis will aid in diagnostic analysis and both autogenous and USDA licensed product development.

To learn more about this exciting opportunity, please Apply Now.

Efficacy Product Manager

admin — Wed, 18 Jan 2012 13:53:48 +0000

The incumbent will manage the development and completion of efficacy studies required for regulatory approval of pharmaceutical products under development for our client in the US. This includes selection, oversight, management, monitoring and support for CRO’s including in-life animal facilities (GCP) as well as clinical investigators for GCP studies. This includes preparing, managing and supporting regulatory submissions relating to efficacy studies.

Qualifications include a DVM, MS and a minimum of 5 years in clinical research or development and/or regulatory environment.

To learn more about this exciting opportunity, please Apply Now.

Clinical Research Coordinator

admin — Thu, 29 Dec 2011 19:20:07 +0000

Our client is a contract research organization that provides comprehensive services supporting all facets of the animal health pharmaceutical development for animal health, biotechnology and life science companies and investors. Clinical Research Coordinators are responsible for the planning, execution and completion of good clinical practice and/or good laboratory practice studies.

The Research Coordinator will communicate with and travel to designated study sites to conduct pre-study site evaluations, study initiation, interim monitoring and study close out visits for preclinical and clinical studies. The incumbent will establish rapport with subcontractors and study site personnel to facilitate communication and compliance with all study activities. Reviews the study records, casebooks and Investigator’s notebooks to ensure contents are current and complete including verification of owner consent, existence and maintenance of source documents and inventory of test supplies. Facilitates clarifications, corrections and data query resolution with study sites or data management, subcontractors and assists with responses to quality assurance audits. The incumbent will assist in management of study test article inventories and other related study materials. Depending on qualifications, may assist in the appropriate response to, and documentation of, adverse events. May serve as Project Manager and have oversight of all communications with a client for a specific clinical study. As Project Manager will coordinate the allocation of monitoring and quality control resources to best meet client needs, including scheduling and oversight of Clinical Research Coordinators. Serves as an ambassador for the company to generate new business and new business leads.

Qualifications include DVM or VMD. Good communication skills, good active listening skills. Experienced in GCP trials, 3-5 years of practice experience. Excellent interpersonal skills. Ability to travel 75% of the time. Basic computer skills, valid driver’s license with clean driving record, willingness to travel. Minimum Experience in data management, quality control and/or quality assurance is helpful.

To learn more about this exciting opportunity, please Apply Now.

Regulatory Affairs Manager/Director/Vice President – Animal Health

admin — Thu, 15 Dec 2011 16:07:59 +0000

The Regulatory Affairs Manager will build a world-class approval and compliance capability for a new specialty Animal Health Company serving the USA, Canada and Latin America. The primary responsibility will be the preparation of pioneer, generic and supplemental submissions to the US CVM and Canadian VDD authorities.

Key Responsibilities include:

Prepare and submit highest quality NADA, ANADA and DIN submissions to the FDA’s CVM and the Canadian VDD.
Maintain current knowledge of FDA and Health Canada regulations and guidance related to CMC, NADA, ANADA, INAD and DIN filings; compiling and reviewing documents for preparation of submissions.
Develop and manage project plans for submissions in conjunction with consultants, communicating with internal departments to obtain documents, and identifying potential issues that may affect timing schedule and submission quality.
Prepare and submit annual reports to Regulatory Authorities; identify and address regulatory and compliance risks and solutions.
Implement and maintain an adequate Quality System including Pharmacovigilance and Recall Procedures

Requirements:

Strong interpersonal skills
Sound knowledge of the US & Canadian regulatory requirements for animal health products.
Ability to deal with scientific and other complex matters.
Bachelor’s degree in a scientific discipline or equivalent.
Regulatory affairs specific qualification would be an advantage
Experience in interfacing with relevant regulatory authorities.
Five to ten years of regulatory experience in the animal health or pharmaceutical industry, with product sourced from abroad.

To learn more about this exciting opportunity, please Apply Now.

Regulatory Compliance Manager

admin — Thu, 15 Dec 2011 05:35:06 +0000

The primary purpose of this role is to provide scientific knowledge and regulatory expertise to our client’s organization. The primary focus of this position is to manage the FIFRA Regulatory Actions and Regulatory Staff to support the sales of our client’s products. Additional maintenance of several FDA product registrations must also be managed. The incumbent will manage a staff of more than five professionals in maintaining current registration status of 200 plus Federal Registrations, State Registrations of 70+ products in all 50 states, and several International Registrations as required. The incumbent will manage four active ingredients through Registration Review including developing a strategy for meeting data requirements of this process at EPA and coordinating data development with internal Product Chemistry area and outside contract labs. The manager will handle all study placement and communication with outside contract labs primarily in the areas of Environmental Fate, Toxicology and Exotoxicology to support product registrations and will manage the Operating Budget for the Regulatory Department. The incumbent will maintain knowledge of all current new pesticide regulatory laws, rules and policies and insure the Regulatory Staff is current on Federal and State FIFRA policies.

Qualifications include a minimum of 10 years of FIFRA Regulatory experience and a thorough knowledge of FQPA and PRIA policies and one on one experience with key EPA Registration Division Managers, demonstrated commitment to communication and innovation in FIFRA product registration. Previous FDA experience is desirable. M.S. or Ph.D

To learn more about this exciting opportunity, please Apply Now.

Director – Regulatory Affairs

admin — Tue, 13 Dec 2011 05:10:54 +0000

The incumbent will direct the regulatory team and cross-functional initiatives as part of business team leadership. Focus on strategic thrusts within the organization and develop regulatory strategies for competitive advantage. The Senior Director/Director Regulatory Affairs will be responsible for building the regulatory strategy and directing a team of five regulatory specialists who are responsible for regulatory over-sight for EPA, FDA, CVM and AFFCO regulated products.

Qualifications include a BS/MS/PhD in science or related field with 10+ years relevant work experience in Regulatory Affairs. Pet Care Regulatory Affairs experience is a plus. In depth knowledge of AFFCO and or EPA regulations. FDA experience is a plus.

To learn more about this exciting opportunity, please Apply Now.

Director – Regulatory Affairs

admin — Fri, 09 Dec 2011 06:35:55 +0000

Our client who is a manufacturer of animal pharmaceuticals has an open position for a Director of Regulatory Affairs. The incumbent will be responsible for strategic and regulatory management of the Company product development program and regulatory maintenance of approved veterinary pharmaceuticals with responsibility for the USA and Canada. The Director will be responsible for overall planning and directing the day-to-day regulatory activities of projects and will play an active role in corresponding with CVM.

Qualifications include a minimum of 10 years in animal health drug development with a working knowledge of all aspects of the drug development process including significant experience with CVM and GLP and GCP regulations and guidelines. The selected candidate should have an advanced degree in life sciences with at least 10 years in animal health drug development.

To learn more about this exciting opportunity, please Apply Now.

Director – Quality Assurance

admin — Wed, 07 Dec 2011 23:12:52 +0000

Our client is a pharmaceutical company which specializes in providing high quality drugs for pets and is searching for a Director of Quality Assurance to be in charge of creating, implementing and overseeing additional quality systems.

The Director must be able to proactively address and lead resolution of compliance issues internally and with external partners and contractors and must have at least 8 years experience in Quality Assurance for a human or animal drug company and will have substantial knowledge of cGMP requirements for multiple dosage forms, along with prior experience with supplier qualification. Additional experience with GDPs and/or GLPs is desirable. International and domestic travel required.

To learn more and/or apply for this opportunity, please Apply Now.

Associate/Manager – Quality Assurance

admin — Tue, 29 Nov 2011 16:54:51 +0000

Company looking for detail-oriented professional to play important role in completing timely, high quality regulatory documents and submissions, managing and maintaining various compliance systems, and implementing product projects.

The incumbent will review and ensure accuracy of various reports and documents for FDA submissions; manage and maintain regulatory and product development document systems; track and maintain current state manufacturing and distributor licenses; manage administrative tasks for bioequivalence studies; maintain product development project timelines and meeting minutes.

Must have at least 2 years experience in a pharmaceutical QA role.

To learn more and/or apply for this opportunity, please Apply Now.