Hess Associates - Current Openings 711-170 The Donway West
Toronto, ON M3C 2E8
416 447 3355

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Biopharmaceutical Positions

2661 Director Reagents/Imstruments Engineering and Manufacturing GTA 2655 Inhalation Toxicology Study Director Montreal 2653 DVM Clinical Veterinarian - CRO Montreal 2640N Medical Device Regulatory Affairs Specialist MA 2619 Genetic Counselor CGC Pennsylvania 2451 Sr. CRO Study Director Preclinical Toxicology Montreal

Job ID: 2661
Position: 2661 Director Reagents/Imstruments Engineering and Manufacturing GTA
Location: Toronto, ON
Description: Toronto arm of leading international medical device organization is looking for a Senior Manufacturing and Engineering.Director. You will be leading a team of engineers and scientists developing and setting up all design transfer processes used to manufacture the instrumentation and associated markers / chemicals / reagents (biomarkers, antibodies). This involves planning, enacting, and documenting the early steps and processes for design transfer / manufacturing. ROLE AND RESPONSIBILITIES: - Direct process, equipment and manufacturing validation. - Documentation review re compliance with ISO13485. - Oversee CAPA for the Sustaining Engineering group. - Work with R&D and Service towards resolving related challenges. - Help design transfer and manufacturing operations improve quality, process, and productivity. - Risk management and best practices re all manufacturing processes. REQUIREMENTS: - BS / MS / Ph.D. engineering - biomedical, mechanical, electrical, related. - 10 to 12 years of industry experience, especially product transfer to manufacturing. - Very strong team leadership - 8 to 10 years min. - Knowledgeable about global regulations related to instruments and reagents, and associated validation/qualification requirements. - Excellent communication, organizational, team building, multi-tasking, and project management skills. Apply

Job ID: 2655
Position: 2655 Inhalation Toxicology Study Director Montreal
Location: Montreal, QC
Description: Montreal, QC rapidly growing GLP preclinical research organization is looking for an experienced Inhalation Toxicology Study Director to work safely with a variety of small animal species. ROLE AND RESPONSIBILITIES: - Designing and preparing inhalation toxicology study plans, reports, and other related documents, ensuring compliance with SOPs.. - Ensuring studies are coordinated with the section leaders' time tables. - Helping, mentoring inhalation technicians, - Interpreting and reporting study data. - Interacting with sponsor companies, consultants and PIs as related to studies. - Client visits and toxicology meetings. - Ensuring compliance with appropriate regulatory bodies (FDA, HPB, EPA, OECD). - Keeping up to date re technology / science. - Environmental safety. REQUIREMENTS: - B.Sc. or M.Sc. in biology / related plus at least 3 years working as an inhalation toxicology study director under GLP. - Background working with variety of small animals. - Strong English, French communication skills. - Excellent time management, problem solving, analytical, report writing, leadership, and client facing skills. Apply

Job ID: 2653
Position: 2653 DVM Clinical Veterinarian - CRO Montreal
Location: Montreal, QC
Description: Montreal, Quebec CRO preclinical testing laboratory seeks a licensed Veterinarian to be responsible for their use of small laboratory animals (from mice up to monkeys) in new drug discovery medical research. DESCRIPTION: Oversee general health and well-being of research animals. Participate in animal medical research on either a hands-on, supervisory, or emergency basis as required. Represent the company in meetings with The Canadian Council on Animal Care and its American counterpart. Considered to be a senior position. REQUIREMENTS: DVM degree and holding either QC or other Canadian provincial license (transferable to QC OMVQ license). European licenses not acceptable. Must have graduated from an accredited college of veterinary medicine. Experience working in a hospital research lab or animal facility, CRO or pharma company. but would consider recent graduate. Must be bilingual (French as one of the languages) or willing to learn French asap. Licensure: https://www.canadianveterinarians.net/resources/examining-board-summary 1. To practice veterinary medicine in Canada in general, students from an accredited school must obtain a licence by passing the North American Veterinary Licensing Exam (NAVLE). 2. The National Examining Board (NEB) is responsible for the administration, in Canada, of a 3-part veterinary licensing examination process. Completion of the exams is a requirement to be eligible to apply for license from any of the provincial veterinary licensing bodies. 3. In addition, to practice in the Province of QC, you must also pass the Ordre des mˇdecins vˇtˇrinaires du Quˇbec (OMVQ) exam. Apply

Job ID: 2640N
Position: 2640N Medical Device Regulatory Affairs Specialist MA
Location: Cambridge, MA
Description: Oportunity to join a well-established, respected medical device organization located in the Greater Boston MA area as a Regulatory Affairs Specialist. ROLE AND OPPORTUNITY: - Product regulatory assessments. - 510(k)submissions. - Compliance. REQUIREMENTS: BS / MS / PhD science, engineering, related. RAC certification great to have. Solid regulatory affairs background with 4 to 6 years related to medical device. 510(k) submissions. Liaising with national, international regulatory agencies. . Apply

Job ID: 2619
Position: 2619 Genetic Counselor CGC Pennsylvania
Location: Philadelphia, PA
Description: Northwest Philadelphia community medical/surgical hospital with a fully NAPBC (National Accreditation Program for Breast Centers) accredited cancer and breast health center offering both medical and radiation oncology services requires a CGC certified genetic counselor, responsible for counseling, genetic risk assessment, and related programs and documentation. ROLE AND RESPONSIBILITIES: - Genetic risk assessment. - Community awareness programs and education. - Explaining genetic risk factors related to cancer development, cancer genetics, role of genetic mutations in cancers, implication for family members, and clinical testing availability for inherited familial predisposition mutations. - Intake patient screening, logistics of appointments, EMRs, sampling, shipping, documentation. - Major role in test result discussion between doctor and patient. REQUIREMENTS: MS Accredited Genetic Counseling program essential. Certification by the American Board of Genetic Counseling, Inc. as a Certified Genetic Counselor a must. Will take new grads. - Able to build the genetic risk counselor program. 2+ to 5 years related experience preferred. No visas please. Relocation assistance for the ideal candidate. Please do not apply if you are not a Genetic Counselor. - Apply

Job ID: 2451
Position: 2451 Sr. CRO Study Director Preclinical Toxicology Montreal
Location: Montreal, QC
Description: Montreal, QC preclinical testing laboratory seeks a Toxicology Study Director to be responsible for inhalation toxicological (GLP) investigation of pharmaceuticals. ROLE AND RESPONSIBILITIES: Designing protocols and programs. Overseeing all technical and scientific activities and in-life monitoring. Responsible for overall conduct of pre-clinical drug studies. Communicating with sponsors. Interaction with internal (QA, Bioanalytical) and external customer/s Writing reports, protocols, and evaluating data. Serving as the scientific representative on corporate committees. Attending scientific meetings. Training of junior technical and scientific personnel. Carry out R&D in line with company objectives. REQUIREMENTS: BSc. (min) plus 5 years as a Tox Study Director in the CRO, biotechnology, OR pharmaceutical industry, including inhalation toxicology. Experience with safety studies of biologics and drugs. Background in the review and tabulation of study data (PK analysis). Knowledge of ADME studies (Absorption, Distribution, Metabolism and Excretion). Able to provide quotes for new incoming studies. Excellent organizational, protocol and report writing skills, working knowledge of GLP, SOPs. Please note that this is GLP, not GMP or GCP. Hands-on, able to deal with the animal experimentation side of testing. French / English bilingual. Apply