AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases. We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare.
About the Role The Analytical Development Chemist I will be responsible for working in accordance with company policy and within GMPs, while contributing technical expertise to support current products and develop future drugs within the AtomVie portfolio or through support of our CDMO functions.
What You Will Do Conduct analytical method development, transfer, validation, and stability testing activities for various analytical techniques which may include Chemical, Biological and Microbiological testing methods. Perform testing of development drug products and stability samples using draft methods. Write test reports, data summaries, technical documents (e.g., specifications, release certificates), and validation protocols with input from SMEs; generate data evaluation summaries and statistical evaluations. Report data in client presentations; attend meetings and present data at client sessions as required. Conduct routine and complex validation activities as per approved protocols and methods; write validation reports in line with regulatory guidelines (ICH, USP, etc.). Support quality control testing of finished drug products and product development material release; coordinate quality testing of excipients, precursors, and drug substances with contract laboratories or research organizations. Perform quality investigations, including non-conformances and testing failures; write investigation reports (e.g., INVs, NCs, CAPAs), prepare CAPA implementation plans, and implement corrective actions. Participate in process improvement initiatives, including initiating change controls, revising methods, and creating new procedures (e.g., STMs, SOPs, forms, templates). Conduct peer reviews of laboratory records, training documents, and technical reports; train colleagues and provide feedback. Manage inventory of analytical reagents, critical materials, reference standards, and consumables; ensure laboratory equipment calibration, maintenance, and troubleshooting with SME guidance. Maintain housekeeping and hazardous waste disposal (chemical and radioactive) in compliance with AtomVie SOPs; monitor procedure effectiveness and propose improvements. Fulfill regulatory documentation requirements, including radioactive material transfer forms, and ensure compliance with Health Canada, FDA GMP regulations, and Canadian Nuclear Safety Commission guidelines. Report radiological contamination events, participate in investigations, and implement corrective actions. Collaborate with team members to achieve outcomes aligned with production and stability plans. Ensure adherence to GMP by maintaining complete records for training, analytical testing, routine operations, and equipment maintenance. Maintain knowledge of regulatory guidance, pharmacopeias, ICH, and applicable business protocols and procedures. Ensure compliance with all health, safety, and regulatory requirements for work activities. Plan, implement, and complete tasks in a timely manner with high quality. Complete all other related duties as assigned.
What You Bring To The Role Experience in method development and validation, and documentation of such studies, is an asset. Knowledge of microbiological testing (Bioburden, Sterility, Bacterial Endotoxins) is an asset. Knowledge of UV, IR, mass spectrometry, and NMR is an asset. Excellent communication skills (in English) and ability to work both independently and cooperatively in a team environment. Proficiency with equipment data processing software such as Empower (Waters HPLC). Proficiency with spreadsheets (e.g. Excel, Google Sheets), word processing software (e.g. Word) and presentation software (e.g., PowerPoint) Good writing skills: ability to write technical documents and reports, and the ability to rapidly input data and retrieve records, statistics, trends, etc., and to prepare technical r presentations for customer meetings.
Requirements University Degree in Biology, Biological Chemistry, Biotechnology, or a related discipline. M.Sc. or Ph.D is preferred. 3-4 years of related experience in in a pharmaceutical cGMP environment, performing analytical chemistry techniques such as HPLC, GC and TLC, microbiology tests such as Bacterial Endotoxins, and/or Biology tests such as IRF, ELISA and SDS-PAGE. Experience working with small molecules, antibodies, proteins and antibody-drug conjugates, protein characterization, UV/VIS, etc. Experience working with sterile products and working in a BSL2 This position requires flexibility in work schedule to support a 7-day work week in support of morning to night shifts in a production environment. Ability to lift 23 kilograms required.
AtomVie Offers Group Health & Dental Benefits (from day 1) RRSP Matching Program Perkopolis Employee Assistance and Wellness Programs Parking Allowance
AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients. We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization.
AtomVie Global Radiopharma Inc . is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases. We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare.
About the Role The Microbiologist will be responsible for completing the day-to-day tasks assigned; this embraces routine microbiological testing including: sterility testing, growth promotion, bioburden testing, microbial identification, and other tests according to the USP and EP.
What You Will Do Conduct routine microbiological testing including: sterility testing, growth promotion, bioburden testing, microbial identification, and other tests according to the USP and EP. Conduct peer review of laboratory records. Conduct routine environmental monitoring according to SOPs. Be responsible for the maintenance of the AtomVie Microbiology Laboratory according to Health Canada GMPs, including records, procedures, disposal of waste, materials, equipment, and routine operations. Support calibration/maintenance of Microbiology equipment. Conduct inventory and management of microbiological materials. Assist in the closure of Change Controls, Non-Conformances, Investigations and CAPAs as specified in the SOPs. Support investigations for Micro related failures and non-conformances. Assist in the writing of technical documents, customer and internal reports, SOPs, protocols. Support the Media Fill program. Understand and work under the Health Canada GMP requirements for sterile pharmaceuticals and the Annex to the Good Manufacturing Practices Guidelines Good Manufacturing Practices (GMP) for Positron Emitting Radiopharmaceuticals (PERs). Plan, implement, and successfully complete assigned tasks in a timely fashion ensuring consistent high quality. Conduct investigations for testing failure and non-conformances and implement corrective actions. Adhere to GMP regulations by maintaining complete records pertaining to all aspects of microbiological testing, routine operations, and equipment maintenance Understand and work under the Health Canada and FDA GMP requirements for sterile pharmaceuticals. Understand and work under the Canadian Nuclear Safety Commission regulations. Ensure compliance with Health and Safety for all policies, procedures and regulations applicable to their work. Complete all other duties as required.
What You Bring to the Role Proficiency with spreadsheets (e.g. Excel, Google Sheets), and ability to write technical documents and reports. Good communication skills (in English) and ability to work both independently and cooperatively in a team environment. Experience in a pharmaceutical cGMP environment, experience in Aseptic Operations and Biosafety Containment Level 2 lab, and working under Canadian Nuclear Safety Commission regulations are assets in this role.
Requirements B.Sc. in Microbiology or a related field. 1 to 3 years of related experience in Microbiological testing such as Growth Promotion, Bioburden, Environmental Monitoring, Sterility and/or Bacterial Endotoxin. This position requires shift work and alternating weekends. Ability to lift and move heavy weights up to 23 kilograms is required.
AtomVie Offers Group Health & Dental Benefits (from day 1) RRSP Matching Program Perkopolis Employee Assistance and Wellness Programs Parking Allowance
AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients. We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization.
AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases. We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe.Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare.
About the Role The Shop Floor Quality Associate works collaboratively with operational stakeholders to ensure quality oversight, leadership and direction to other departments’ SMEs through real time decision making in order to ensure AtomVie remains in compliance to its systems, external client expectations and Good Manufacturing Practices (GMPs).
What You Will Do Effectively drive the management and oversight of quality issues (in real time where possible) Collaborate with Production and Microbiology (where necessary) to provide real-time oversight of Production activities by advising Operators on best practices and reinforcing GMP Make decisions using problem-solving skills (in real time where possible) and support SMEs with identifying effective corrective/preventive actions Act as QA’s representative for the release of GMP areas Provide documentation support and perform routine QA review of records (i.e., pest control, housekeeping, logbooks, binders, etc.) Support and participate in audits by regulatory authorities and AtomVie clients as needed Serves as the Quality Assurance representative on cross-functional teams to drive quality focused decision making Communicate quality and compliance issues to all relevant stakeholders in a timely manner Ensure AtomVie is inspection ready and is operating within a compliant quality environment Ensure compliance with Health and Safety for all policies, procedures and regulations applicable to their work. Support all other duties as assigned
What You Bring to the Role Adaptability with a desire for working in a fast-paced, growth-oriented environment Ability to work with a sense of urgency, prioritize work, meet objective/deadlines with strong organizational skills Strong project management skills with the ability to work independently and within a team Ability to drive improvement projects and deliver high-quality work even under pressure Ability to handle multiple tasks and competing priorities concurrently and in a timely fashion Ability to solve problem with evidence of good judgment and decision-making skill Strong client-facing and teamwork skills
Requirements BSc or equivalent in Pharmacy, Engineering, Chemistry, Microbiology or a related field 1-2 years of relevant experience in the pharmaceutical, radiopharmaceutical or biopharmaceutical industry is required, with up to 5 years preferred Strong understanding of Health Canada and FDA GMP regulations, with specific knowledge of regulations as they pertain to sterile products Flexibility in work schedule to support a 24/7 production environment
AtomVie Offers Group Health & Dental Benefits (from day 1) RRSP Matching Program Perkopolis Employee Assistance and Wellness Programs Parking Allowance
AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients.We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization.
AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases. We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare. About the Role Are you passionate about science and chemistry? Do you thrive on tackling complex challenges and want to make a real impact in the field of radiopharmaceuticals? If you have a wealth of experience in the pharmaceutical industry and are looking for your next exciting opportunity, AtomVie is the place for you. As an Analytical Scientist, will be an expert in the areas of analytical test method development, transfer, and validation. They will provide technical leadership and project management support accross Analytical Development, Production and QA teams at AtomVie. The incumbent establishes work schedules and assignments to ensure the successful completion of tasks while ensuring consistent high quality. What You Will Do Lead development projects, prepare presentations, attend client meetings, and provide expert technical advice to clients. Plan, implement and successfully complete assigned Analytical Development (AD) projects (e.g., method development, transfer, validation activities, and related tasks) while ensuring consistent high quality and compliance with cGMP. Provide analytical support for process development including characterization of starting materials, intermediates, API, and finished products. Responsible for new equipment purchases and installation (quotes, URS, change control, SOPS, STMs, forms, IQ/OQ/PQ, etc.) Write test reports, data summaries, and statistical evaluations/trending. Conduct review of Analytical Development laboratory records / notebooks. Perform troubleshooting and investigations in cross-functional teams under the direction of management. Assist in the management of third-party analytical testing service providers. Conduct all work in accordance with AtomVie SOPs and raise any deviations immediately to the attention of Management Perform quality control ' testing of incoming materials, drug substances and finished drug products according to standard testing methods. Perform peer/technical review of QC data. Write, revise, and review INVs, NCs, CAPAs. Perform routine quality operations including technical document review, calibration/maintenance of equipment and inventory/material management of incoming raw materials/container closures and analytical reagents, when required. Troubleshoot equipment systems (HPLCs, GCs, LSC, Gamma Counter, Gamma Spec, etc.). Responsible for maintenance of documentation to fulfill applicable regulatory requirements relating to nuclear safety. Ahere to Health Canada, GMP/GDP regulations and maintain compliance with Health, Safety and Environment protection rules Complete all other related duties, as required. What You Bring to the Role Working knowledge of GLP/GMP and applicable FDA, EMA, ICH, and EANM guidance documents. Good verbal and written communication skills, strong numeracy skills and the ability to work both independently and as part of the team Demonstrated ability to successfully organize, prioritize, manage time, multitask, and troubleshoot. Proficiency with spreadsheets and Ms. Office and ability to write technical documents and reports. Flexibility in work schedule to support a 24/7 production environment based on customer demand, including weekends. Ability to work in a facility that handles radioisotopes and radiopharmaceuticals. Capable of standing, walking, and/or sitting, for extended periods of time. Ability to lift 23 kilograms required. Requirements M.Sc. or Ph.D. in Chemistry, Chemical Biology, Biotechnology or a related discipline. 10 + years’ hands-on experience in a pharmaceutical GMP environment, specifically in laboratory sample preparation techniques, operation of HPLC, GC, and TLC, and method transfer, development and validation. Knowledge and experience in UV, IR, mass spectrometry and NMR, microbiological release testing of pharmaceuticals (e.g. Bioburden, Sterility, and Bacterial Endotoxins) and testing of biologicals are assets. AtomVie Offers Group Health & Dental Benefits (from day 1) RRSP Matching Program Perkopolis Employee Assistance and Wellness Programs Parking Allowance AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients. We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization. #J-18808-Ljbffr
AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases. We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare. About the Role The Chief Business Officer (CBO) at AtomVie Global Radiopharma (AtomVie) is a key leader responsible for defining and executing the business development strategy, aligning company’s vision and ambition. The CBO will be managing the commercial effort in onboarding clients in AtomVie’s new facility for the large-scale manufacturing of marketed radiotherapeutic drug products maintaining a credible relationship with the BOD and the shareholders, the CEO, and AtomVie’s Leadership Team (LT). The CBO has a key strategic responsibility contributing to and executing AtomVie’s vision and business plan, facilitating growth and expansion of its CDMO Radiopharma operations, through the growth of a healthy client pipeline and securing commercial contracts as per the capacity of the new facility. The CBO is also responsible for supporting the CEO, the BOD, and the LT in developing and implementing sound short and long term business development strategies and decisions, based on pulsing and analyzing the market. What You Will Do Develops, directs, and executes the business development and growth strategy plan, in alignment with AtomVie’s business and financial vision and goals. Nurtures the right partnerships and fosters the eco-system that enables greater visibility in the market and the implementation of a service offering tailored to the market demand. Facilitates and fosters creative marketing and business development initiatives to maximize lead generation and commercial contracts. Builds a cohesive risk management strategy across customer lifecycle and program attrition – from lead generation to contract execution to fulfilment of contract obligations. Continuously monitors and analyses the market and the competitive landscape, works closely with the LT to develop the quarterly and annual forecasts in alignment with the COO and CFO. Present and discuss with the authorized stakeholders internally and externally as directed by the BOD and/or the CEO. Works closely with the CEO and LT to regularly review the offered services and products, assess the introduction of new services and/or products, maximizing the ROI while utilizing AtomVie’s know-how and technical capabilities. Designs a global business development organization -as applicable- and directs, develops, and mentors a team of professionals for all aspects of business development at AtomVie, ensuring the staff retention and engagement by enhancing their contribution and involvement. Supports the LT and department heads on strategic and critical departmental projects discussions and decision making by providing business and market insights and analysis to validate and/or challenge the projects’ proposals and plans. Continuously improves the departmental practices and policies to support AtomVie’s goals and to promote growth across the company. Ensures the optimization of the business development processes in coordination with various departments to improve the response rates to existing or potential clients and the conversion of business leads into active clients on the short and longer terms. Participates in developing a client-centric service culture throughout the client’s journey, addressing the clients’ needs, requirements and feedback in line with AtomVie’s business plan. Works with the CEO and the BD team on securing commercial contracts to satisfy AtomVie’s expansion plans in alignment with the company’s long-term strategic plan. Demonstrates strong focus on budgets, targets and achievements of goals. Demonstrates responsibility and accountability for revenue and sales numbers with agreed profit margins. Capable of leading and foreseeing market changes and influencing through participation in industry forums and discussions. Experience Necessary University Degree in Finance, Business or equivalent. A master’s or an MBA degree is an asset. Relevant scientific background an asset. 15 years’ progressive experience in business development, contract execution and strategic planning, including experience in sales and leadership roles in a fast-growing environment. Recent experience in CDMO manufacturing within pharma or life sciences industries is required. Result-oriented leadership with a wide perspective and vision from strategy to operations. Demonstrated experience in leading a business development team successfully in promoting sustainable business expansion. Well-established contacts and ability to promote services in a fast-growing and changing business environment. Excellent communication and negotiation skills in B2B commercial business development. Demonstrated abilities in building and nurturing business relationships. Strong focus on the execution and delivery of the short- and long-term business development and financial goals and plans. Hands-on experience in business dealings. Effective attention to details, high levels of work ethics, integrity, accuracy, confidentiality, and accountability. Effective verbal and in-writing communication skills, presentation skills, negotiation skills, conflict management, and leadership skills. Self-directed travel ability and working efficiently remotely. AtomVie Offers Group Health & Dental Benefits (from day 1) RRSP Matching Program Perkopolis Employee Assistance and Wellness Programs Parking Allowance AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients. We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization. #J-18808-Ljbffr
