Director of Quality Assurance – Southeast

The Director of Quality Assurance will develop and deploy the quality system for manufacturing facilities to assure systems and procedures are compliant pursuant to government regulations, industry standards and Company policies and procedures. The incumbent will manage the Quality Organization in support of business and Company initiatives.  The successful candidate will interface with Production, Regulatory Affairs, Marketing, New Product Development and other departments to maintain awareness of Quality activities.  The incumbent will understand and deploy processes to assure conformance to government regulations, industry standards and Company policies. The incumbent will manage the team for regulatory inspections and will assess and advise Executive Leadership on quality decisions. The incumbent will manage interactions with vendors, suppliers and FDA inspectors concerning the quality of products, systems and processes.  The incumbent will identify and manage continuous improvement projects that may span multiple sections or departments with the goal of achieving quality, reliability and cost improvements. The incumbent will manage quality compliance for Contract Manufacturers, will manage GMP and job-specific training program, will manage internal and external auditing, develop a corrective action program to ensure the appropriate responses to deviation or audit deficiencies, review and approve SOP’s, handle production process monitoring, protocol review and batch  record documentation and approval.

Qualifications include B.S. in science or engineering, advanced degree preferred, 10+ years of Quality Assurance in the pharmaceutical products or supplement industry with 7 years of management experience., strong knowledge of FDA government regulatory requirements pertaining to manufacturing of pharmaceutical products or supplements, strong leadership skills and success managing a team, strong analytical and problem solving skills, success working with multifunctional, global teams, excellent interpersonal, communication, negotiation skills, and a high level of human relations skills in selecting, developing and motivating people. Excellent motivational and cross-functional team building skills are required.

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Animal Health Clinical Research Associate (CRA) (virtual location, anywhere in the United States)

Currently 3 openings.

The incumbent will have the overall management and study site monitoring of clinical sites, which include conduct of pre-study and initiation visits, interim monitoring, and close out visits in accordance with company standard operating procedures. The incumbent will also have on and off-site monitoring responsibilities  that include ensuring study staff has received proper training to conduct the study according to the protocol and applicable regulations; as well as maintaining protection of study patients by verify that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements, including VICH-GCP guidelines.  The incumbent will prepare accurate and timely monitoring trip reports, review progress of projects and initiate appropriate actions to achieve target objectives, and organize and present at investigator meetings.  The incumbent will participate in the development of protocols and CRF/EDC as assigned, including writing clinical trial reports and interact with internal work groups to evaluate needs, resources, and timelines.  Additional responsibilities include recruitment of potential investigators, preparation of submissions, preparation of study related documentation, and organization of meetings as well as other tasks as instructed by supervisor.

Qualification requirements include a university/college degree (life science preferred) or certification in a related allied health profession from an accredited institution (e.g. nursing, laboratory, medical/technical).  Experience required includes a minimum of two (2) years of animal health clinical research monitoring experience (including pre-study, initiation, interim monitoring, and closeout visits). In lieu of the previous requirements, candidates with > four (4) years supervisory experience in a health care setting or > three (3) years clinical research experience in the human pharmaceutical or CRO industries (including monitoring) may be considered.  An average of 50-60% of travel is required.

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Manager of Development Projects

The incumbent will be the Project Team Leader for pharmaceutical compounds in pre-clinical and clinical development. The incumbent will design registration and product development operating plans, manage all clinical development aspects of pharmaceutical compounds including design of protocols for product registration studies in the EU and US. Functions include preliminary safety, metabolism, pharmacokinetics and dose titration studies, first efficacy studies in laboratory conditions and pharmacokinetics studies with the final formulation, efficacy studies, safety studies and field trials. The incumbent is responsible for negotiations on the clinical program with VMD, EMA, FDA and other relevant regulatory agencies. The incumbent will prepare parts III and IV (Safety and Efficacy Technical Sections) of new drug submissions for Veterinary Medicinal Products/New Animal Drugs. The incumbent will provide clinical advice and trend analysis for pharmacovigilance reports to relevant regulatory authorities and will follow up on all research and development projects as required by supervisor.

Qualifications include experience in research and regulatory veterinary medicine including interaction with governmental agencies, understanding of product development,  protocols, Good Clinical Practice guidelines, research reports and dossier preparation. Qualifications include a D.V.M, V.M.D, B.V.Sc. or equivalent with relevant experience.

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Quality Control Manager

The Quality Control Manager will oversee QC Chemistry laboratory operations to ensure cGMP compliance. The Quality Control Manager is directly responsible for in-house testing and is the point of contact with external laboratories performing testing of API and Drug Product. Qualifications include a B.S. in chemistry or related field, and experience obtained through working in an analytical laboratory. The successful candidate will have 10+ years of experience with at least 5+ years in direct analytical management in the area of pharmaceutical/biopharmaceutical industry in a global company with knowledge of industrial standards such as ICH guidelines, cGMP/GLP and compendial requirements. The incumbent will have experience in chemical and pharmaceutical operations and site QC/QA, which enables first-hand knowledge of manufacturing, QC/QA, regulatory and interface with R&D. The incumbent will have excellent written and verbal communication skills with previous experience dealing with FDA and other regulatory agencies.

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Project Team Leader – Virtual Role

The Project Team Leader will lead a multifunctional team that achieves program goals and business objectives by developing and implementing the product development plan with support from the function team representatives. The programs will span the different phases including preclinical development, clinical manufacturing and commercialization. The Project Team leader will help to determine program strategies as well as with internal functional leads and external contract resources to implement and execute on all aspects of product development.

The incumbent will develop and refine the product strategy by collecting,  pressure-testing and integrating inputs from internal and external functional experts and will manage the evolution of product strategy and development plans in light of new findings and new opportunities. The incumbent will establish program goals, milestones, timetables and resource requirements and ensure that each function has planned and budgeted to meet the program goals. The incumbent will monitor the progress of activities and deliverables to ensure program objectives are met.  The incumbent will build, maintain and chair the Project Team as the primary structure for communication and coordinating among functional area representatives on the team.

Qualifications include an Advanced degree in life sciences, at least 10 years of successful experience developing pharmaceutical or biotechnology drugs; a historical core competency in clinical development, regulatory affairs or new product commercialization, at least 7 years of experience in program management with a proven track record, acting as senior point of leadership for a key development stage product or product portfolio with responsibility for both strategy and execution, an in-depth understanding of the pharmaceutical development process, Animal Health Industry experience preferred The incumbent must have a strong understanding and competency in planning processes and decision making, outstanding written and verbal communication skills, excellent analytical and logical rigor; objectivity, high energy and drive, strong work ethic and be flexible.

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Associate Director – CMC

The Associate Director, Chemistry, Manufacturing and Controls is responsible for sourcing activities of active pharmaceutical ingredients (APIs) and intermediates for new pharmaceutical products from pre-development through commercialization. This role will manage CMC activities from early stage development through post launch, establish requirements for precise CMC activities needed to support programs; identify, evaluate and manage contract resources required to support drug substance synthesis, drug product manufacturing, analytical testing, packaging and labeling for all stages of development. The role is responsible for availability of clinical supplies, complete submissions of regulatory filings and development of robust manufacturing processes and analytical methods. The incumbent will manage all aspects of launch readiness in close collaboration with other members of the R&D organization, Medical Regulatory and other departments. This is a leading role in selection and collaboration with external development and manufacturing partners The Associate Director will build and manage vendor relationships to ensure productive and high-functioning working relationships with external partners. The incumbent will provide expertise and scientific direction regarding the evaluation and selection of new product technologies. The incumbent will develop regulatory and compliance strategies with Regulatory and Quality Assurance to ensure approval of regulatory submissions and compliance at contract vendors and will contribute to the preparation of CMC sections for regulatory submissions.  This role may be based in San Diego or San Francisco.

Qualifications include a Ph.D. in chemistry or related field, 3-5 years minimum experience in a variety of drug product development programs, experience managing biopharmaceuticals and small molecules and a variety of dosage forms (sterile injectables, capsules, tablets) and packaging configurations. Prior experience in development and launch of pharmaceutical products is a plus, extensive experience in outsourcing drug development and manufacturing, broad understanding of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies. The successful candidate will have detailed knowledge of ICH, , FDA regulatory guidance for CMC, oral and written communication skills and excellent problem skills.

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Head of Clinical Development – Virtual Role

The Head of Clinical Development provides scientific knowledge of the product lines and reviews and reports on the mechanisms of actions of all active ingredients and the function of the inactive excipients; as well as spearheading the development and discovery efforts requiring a clinical veterinary perspective and coordination of efforts as needed.   Key responsibilities include the design and oversight of late-stage or post-launch clinical programs; locate the appropriate CRO for the product testing and reviewing protocol and budget and receive management approval, plan and coordinate the work in accordance with good science and applicable regulations/guidelines.  The incumbent will monitor studies at critical study time points and report findings in pivotal and non pivotal targeted animal studies in support of new and existing products with strict compliance with applicable regulations; as well as analyze the literature and FDA documents and design clinical strategy for a new product. The incumbent will work closely with marketing and sales pre and post launch of Veterinary and OTC companion animal products to ensure scientific validity to all sales and marketing claims and promotions.

Qualifications include a Doctor of Veterinary Medicine degree and 3-5 years of pharmaceutical research and development experience. Specialty training is a plus. 30% travel is required.

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Senior Manager Product Development

The Senior Manager, Product Development will support activities with expertise in drug formulation, product manufacturing and regulatory. The Product Development Manager will provide support in managing contractors. This role provides formulation expertise and selects the most appropriate formulation for pre-clinical, clinical and commercial use. The incumbent solves problems related to formulation, supply or other drug product or drug substance challenges, leads in the outsourcing effort toward the development and manufacturing of drug product formations. The incumbent will manage drug substance and drug product logistics to ensure sufficient materials are available to support planned nonclinical and clinical studies and helps develop and manage budgets for R&D projects. The incumbent will write/review protocols for manufacturing drug products and actively participates in preparations for internal audits and regulatory inspections as necessary. The incumbent will prepare CMC sections of regulatory filings and acts as the development lead for selected products in life-cycle activities. The incumbent will provide expertise and scientific direction regarding the evaluation and selection of new product technologies, in association with cross-functional evaluations and requirements from research, clinical, commercial and regulatory teams.

Qualifications include a Bachelor’s degree or higher in Pharmacy, Pharmaceutics, Chemistry, Chemical Engineering or a closely related field is required. A minimum of 3-5 years experience in the Pharmaceutical Industry including experience in formulation and process development of pharmaceutical dosage forms, familiarity with product development, clinical supplies processes, regulatory guidelines and experience in regulatory submissions (CMC Module 3) is required. Experience in working with outsourcing model is preferred.

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Director of Development

The incumbent will lead one or more drug development programs and be responsible for all drug development activities from proof-of-concept studies through regulatory approval.  The incumbent will direct pre-clinical and clinical studies, cooperate with contract research organizations, coordinate formulation development and manufacturing activities as well as manage the overall development projects.  Additionally, the incumbent will  partner with and coordinate R&D management and staff to identify and evaluate capabilities of contract research organizations (CROs) who will be supporting development activities. The incumbent will represent the company at FDA’s Center for Veterinary Medicine and work with consultants and CROs on regulatory strategies as well as draft and submit required regulatory documents.  The incumbent will develop and present summaries of scientific data to management, Board of Directors, and at scientific meetings as directed by management.

Qualifications include a minimum of 5 years in animal health drug development or equivalent with project management experience is desired, with a working knowledge of managing complex projects in a regulated environment.  DVM/VMD is preferred but a MS or PhD in life sciences with significant animal health drug development experience or equivalent will be considered.  The successful candidate will be able to work effectively in a high-energy, new company environment and be a flexible thinker, adaptive to emerging issues, comfortable working without defined boundaries or processes.

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Regulatory Affairs Manager

The Regulatory Affairs Manager will provide early guidance, review and approval of regulatory strategy, labeling and  promotional material for new products. This role coordinates the format and information in the development of regulatory submissions including US. Veterinary Biologics Establishment License Applications, U.S. Veterinary Biological Product License Applications, New Animal Drug Applications (NADAs) and Investigational New Animal Drug submissions (INADs). The incumbent will develop and conduct the training of R&D, Marketing, QA and other groups concerning regulatory issues and will evaluate and implement procedures pertaining to corporate regulatory activities.  The Regulatory Affairs Manager will develop complex domestic and global regulatory strategies and submissions in support of new and existing marketing authorizations. The position will review and approve all labeling communications to trade publications, news media release, sales presentations and technical bulletins and analyze the support data for claims verifications and for regulatory compliance.

Qualifications include a Bachelor degree or higher in a biological science, animal science, chemistry or a clinical field. A DVM or equivalent degree and PhD is desirable. The position requires strong verbal and written communication skills, ability to multi task, technical system skills, working knowledge of US and global regulations, negotiation skills, interpersonal skills, 5+ years of experience with Regulatory Affairs or FDA/USDA experience as a reviewer of product applications, experience with NADAs and/or Veterinary Product License Applications, understanding of 21 CFR 500-599 and/or 9 CFR 101-124, drug and/or biologic manufacturing requirements, statistics and sampling methods.

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