Hess Associates - Current Openings 711-170 The Donway West
Toronto, ON M3C 2E8
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Biopharmaceutical Positions

2640N Medical Device Regulatory Affairs Specialist MA 2637 Product Manager Drug Development E / W Coast 2632 Biochemical Reagent Manufacturing Manager GTA 2622 ICP Ion Beam Optics Physicist GTA 2619 Genetic Counselor CGC Pennsylvania 2451 Sr. CRO Study Director Preclinical Toxicology Montreal

Job ID: 2640N
Position: 2640N Medical Device Regulatory Affairs Specialist MA
Location: Cambridge, MA
Description: Oportunity to join a well-established, respected healthcare imaging organization located in Cambridge, MA as a Regulatory Affairs Specialist, reporting to a senior manager. ROLE AND OPPORTUNITY: - Regulatory assessments related to new products / changes to existing products / manufacturing changes. - 510(k) and IDE submissions; product registrations. - Input re product develoment and design reviews. - Compliance related to training, labeling, promotional materials. - Keep uo with international and FDA medical device regulations / requirements. - Post-market compliance. REQUIREMENTS: BS / MS / PhD science, engineering, related. RAC certification great to have. >10 years' regulatory affairs background. 5+ years' medical device regulatory experieince. Background preparing relevant 510(k)s (internaitional of interest). Experience liaising with regulatory agencies (international of interest). Strong MS Office, English oral and written communication, team player skills. Apply

Job ID: 2637
Position: 2637 Product Manager Drug Development E / W Coast
Location: Central Valley, CA
Description: LOCATION: New England OR Central Valley, California CLIENT: Preclinical CRO focusing on small animal R & D and testing services (pharmacology, biochemistry, genetics) involved in new drug product development to treat a wide range of conditions across the disease spectrum. OVERVIEW: - Steering product development from ideation to transfer to business units. - Gathering and digesting market information from all sources into new product ideas and strategies. - Competition, price, timelines, investment costs. ROLE AND RESPONSIBILITIES: - Act as person in charge of new product lines, taking full responsibility for executable business plans. - Gather and digest market information from all sources into new product ideas and strategies. - Determine market potential for potential products and develop business plan. - Supplier and customer licensing agreements, marketing plans and sales training. - Setting up operational plans, including supply chain and inventory issues, timelines and investment requirements. - Success metrics, risks, progress reports. REQUIREMENTS: - BS / MS / Ph.D. Life Sciences and MBA of interest. - Previous product launch experience. - >5 documented years in product development or management, or similar business environment position. - Background in drug development or related preferred. - Consensus building decisive leader and team player with great interpersonal skills. - Ability to travel 20 to 25% if living in CA, higher if in New England. Apply

Job ID: 2632
Position: 2632 Biochemical Reagent Manufacturing Manager GTA
Location: Toronto, ON
Description: Our Toronto client, a rapidly growing creator, manufacturer, and seller of cell analytical instrumentation is looking for someone to manage all reagent (biochemical) consumables manufacturing on site (ISO 13485). You will be detail-oriented and have a proven background in scaling up manufacturing operations while maintaining the delivery of quality existing products. ROLE AND RESPONSIBILITIES: - Scale up of present and transfer of new biochemical reagent manufacturing processes, in compliance with ISO 13485 / QC. - Formulation, packaging resources, documentation (SOPs, test reports, manufacturing controls). - Scheduling, working with other departments - marketing, R&D, supply chain. - Engage in supplier evaluation. - People and safety issues. REQUIREMENTS: Preferred Ph.D. or M.Sc., will consider B,Sc, Chemistry, Biology, related. 10 - 15 years' involvement in the setting up and manufacture of R&D and clinically used biological consumables / reagents. Manufacturing admin - such as schedules, documentation. Manufacture of antibodies, conjugates, molecular biology agents; any IVD manufacturing of interest. Background using lab equipment and setting up QC. Previously responsible for reagent/consumable kit manufacturing from scratch. Will relocate for the right individual (under NAFTA only). . Apply

Job ID: 2622
Position: 2622 ICP Ion Beam Optics Physicist GTA
Location: Toronto, ON
Description: Our Toronto client is a leading edge company working in the optics space. They are currently seeking a Physicist or engineer with an Interface Ion Beam technology background (not nuclear). You will play a pivotal role in the R and D of new ion sources (plasma) and their application to ion optics in mass spectroscopy. You will be involved in product development and commercialization, handle invention disclosures and patent applications, and collaborate with internal and external scientists as needed. ROLE AND RESPONSIBILITIES: - Work in conjunction with R & D on new plasma-based ion sources and ion optics interfaces related to mass spectroscopy and instrumentation used to analzye cell biomarkers. - Optimize new plasma-based ion sources and ion optics interfaces related to mass cytometry. - Automated single cell microfluidic system testing with variety of tissue sample formats. - Data analysis, documentation, transfer of new knowledge into possible commercialization. - Operate and troubleshoot company analytical equipment including Mass Spectrometer related equipment and other types of bioimagers. REQUIREMENTS: - PhD/MS Physics or engineering including 3 years of Ion Beam technology. - Hands-on background in both experimental & theoretical parts of engineering physics e.g. plasma physics, ion optics, and space charge limited ion beams - Able to apply this new knowledge to updating and improving analytical instrumentation - May consider exceptional new grads. 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. - 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 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. 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 nice to have. Apply