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

2646 Senior Quality Director Medical Device E ON 2647 Director of Operations Medical Device E ON 2640N Medical Device Regulatory Affairs Specialist MA 2632 Biochemical Reagent Manufacturing Manager GTA 2630 Ph.D. Application Support Director: Bioanalytical Equipment GTA 2631 Ph.D. Application Support Director: Bioanalytical Equipment SFO 2622 ICP Ion Beam Optics Physicist GTA 2619 Genetic Counselor CGC Pennsylvania 2451 Sr. CRO Study Director Preclinical Toxicology Montreal

Job ID: 2646
Position: 2646 Senior Quality Director Medical Device E ON
Location: Eastern Ontario, ON
Description: Senior Quality Director: Medical Device / Bioengineering / Cytotherapy Eastern ON Join a fast growing company in Eastern Ontario, on the cutting edge of bioengineering, providing living solutions for a variety of clinical treatments. Your strong leadership skills are required to guide this company, part of a large global organization, in terms of quality, compliance, audits, safety, ensuring excellent product development. ROLE AND RESPONSIBILITIES: - Key member of site leadership team. - QC / QA responsiblity, meeting company objectives while in compliance with GMP/ISO 9001 and 13485, building team member consensus. - In charge of customer on-site audits, setting up supplier quality programs, supporting R&D, and planning strategy for global process development and controls. - Interacting with global gene therapyand cellular therapy, while partnering with personalized medicine units. - Company wide safety education and compliance. REQUIREMENTS: - BS / B.Sc. minimum in life sciences / related. - Proven experience in key bio leadership role(s), at senior upper management level. - 10 years (post graduation) as key Quality Leader in manufacturing of either medical device (FDA Class 2 (II) or above), cell based biologics, medical equipment, or laboratory analytical or diagnostic instruments. - Strong people management, departmental management skills, able to see the big picture. - Proven experience guiding a multi-unit company within a complicated business structure. - Background in QA / QC product development within matrix organization. - Interacting with external and internal stakeholders, clients. - Great at gaining consensus. - Knowledgeable re USFDA 21CFR820 - such as documentation, facilities design controls, supply chain, audits, training, clean room ISO, failure modes and effects analysis (FMEA). - Willing to live in / relocate to Kingston, ON area. - Must be legally allowed to work in Canada at this time. Apply


Job ID: 2647
Position: 2647 Director of Operations Medical Device E ON
Location: Eastern Ontario, ON
Description: Director of Operations Eastern ON Join a fast growing company in Eastern Ontario, on the cutting edge of bioengineering, providing living solutions for a variety of clinical treatments. Your strong leadership skills are required to guide this company, part of a large global organization, in terms of growth, quality, compliance, manufacturing, customer service, and departmental alignment with organizational goals. ROLE AND DIRECT RESPONSIBILITIES: - Very senior position, wherein you will assume legal responsibility for all site-related activities. This is not a position for new grads. - Leadership for all supply chain, EHS, quality (GMP compliance), engineering, biologics equipment and disposables manufacturing (and scale-up) for all site-specific services and products, towards profitability and great customer service. - Ensure alignment of all site-related functions and businesses. - Set up internal audit, EHS programs in line with global corporate practices. - Troubleshooting and continuous improvement for supply chain and manufacturing. - Budgeting, scheduling, meeting performance goals. REQUIREMENTS: - BS / B.Sc. biology, engineering, or biology. - Proven experience in key bio leadership role(s), at senior upper management level, able to coordinate departments within a matrix and gain consensus. - Previous proven leadership in roles outlined above. - 5 to 10 years' (post graduation) background leading sites involved with medical device, disposables, or biological manufacturing equipment. - Coaching, training, ensuring health and safety, quality and cGMP compliance. - Willing to live in / relocate to Kingston, ON area. - Must be legally allowed to work in Canada at this time. Apply


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: 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: 2630
Position: 2630 Ph.D. Application Support Director: Bioanalytical Equipment GTA
Location: Toronto, on
Description: Our client is a leading edge company working in the optics space. They require a Ph.D. Application Support Director to strategically lead a team of specialists training and supporting customers in the application of company instrumentation used for cell characterization. External and internal specialists providing product application support, technical writing, online learning, as well as troubleshooting. There is also a component related to new product development and marketing. Role available in the Bay area, CA. ROLE AND RESPONSIBILITIES: Develop and implement a technical training plan that will work for both external and internal customers. Escalated application issues. Employee development, budgeting. Making sure that new cell analysis products match customer requirements. Work with other departments to service their requests for application support, writing, content, online learning assistance. Create and upgrade materials used for training - manuals, white papers, application notes, and presentations. REQUIREMENTS: Ph.D. in biology/genetics/life sciences/related followed by experience in molecular or stem cell biology,cancer or immunology research working with sequencing, PCR, or mass spectrometry/related. 8 -10 years of pertinent experience in industry, showing increasing team leadership building roles. Have set up OR participated in training programs; online learning nice to have. Some travel. Excellent customer training, communication, organization, leadership, interpersonal communication skills. Background working within a biotech technical writing lifecycle. Proven experience developing customer training online learning. Great MS Office, software computer skills; and eLearning software an asset. Example might be someone who is an Application Support Director. Apply


Job ID: 2631
Position: 2631 Ph.D. Application Support Director: Bioanalytical Equipment SFO
Location: Bay Area, CA
Description: Our client is a leading edge company working in the optics space. They require a Ph.D. Application Support Director to strategically lead a team of specialists training and supporting customers in the application of company instrumentation used for cell characterization. External and internal specialists providing product application support, technical writing, online learning, as well as troubleshooting. There is also a component related to new product development and marketing. Role available in the Bay area, CA. ROLE AND RESPONSIBILITIES: Develop and implement a technical training plan that will work for both external and internal customers. Escalated application issues. Employee development, budgeting. Making sure that new cell analysis products match customer requirements. Work with other departments to service their requests for application support, writing, content, online learning assistance. Create and upgrade materials used for training - manuals, white papers, application notes, and presentations. REQUIREMENTS: Ph.D. in biology/genetics/life sciences/related followed by experience in molecular or stem cell biology, cancer or immunology research working with sequencing, PCR, or mass spectrometry/related. 8 -10 years of pertinent experience in industry, showing increasing team leadership building roles. Have set up OR participated in training programs; online learning nice to have. Some travel. Excellent customer training, communication, organization, leadership, interpersonal communication skills. Background working within a biotech technical writing lifecycle. Proven experience developing customer training online learning. Great MS Office and other software computer skills; and eLearning software nice to have. Example might be someone who is an Application Support Director. 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