EVONIK Vancouver Laboratories (VAN), the operating drug delivery service site of Evonik Canada Inc., is a Contract Development and Manufacturing Organization (CDMO) that provides CMC services to biotechnology and pharmaceutical companies engaged in the development and manufacture of complex delivery-based drug formulations. EVONIK has a successful track record of helping Customers move their programs forward. Evonik’s Vancouver business operations is a development partner to the world’s pharmaceutical companies for parenteral lipid nanoparticle drug products. As an enabling contract development manufacturing organization (CDMO) partner, we offer drug formulation design, process development, scale-up, and clinical production. EVONIK’s range of services extends from initial formulation prototype identification, manufacturing process development & scale-up, analytical method development & validation to support raw material, in-process, release and stability testing, all the way through to sterile product manufacturing under GMP for Phase I-II clinical trials. Products include the LIPEX™ line of Extruders, which are designed to enable small-scale to commercial scale manufacturing of liposomal drug products. With over 25 years of experience and having transacted business in about 50 different countries, WHY EVONIK? Evonik offers excellent benefits such as competitive compensation, benefit & pension plans, vacation and time off, and many wellness resources. And there is more...access to a Comprehensive Health Promotion program and Regional and Global resources for ongoing training and development. Best of all, you will work within a great team of professionals in an engaging workforce who value trust and openness. Are you looking to join a dynamic company with an exciting and expanding future in the pharmaceutical industry? Then Evonik is the next step in your career. Grow with us! Click here to learn more from our Vancouver Laboratories employees: https://www.youtube.com/watch?v=s5X15sKUEzs WHY VANCOUVER? Vancouver has something for everyone! British Columbia is beautiful and exciting. From the people, to the mountains, to the sprawling coastline, everywhere you look. Nestled on the warm Pacific Coast with the Rockies blocking cold arctic winds. Vancouver has the good fortune of being spared the typically chilly winters associated with Canada. Vancouver is often called ‘two cities in one’ because people are equally prone to enjoy the bustling nightlife and experiencing a plethora of activities in the surrounding nature. Imagine enjoying a day-long trek through our world-renowned rain forests, then heading into the city for a night out. Vancouver truly is as beautiful as people say and more. What we offer You will work on exciting and challenging topics together with a team in an ultra-modern, innovative and creative environment. Intensive on-the-job training with expert colleagues guarantees you will quickly become familiar with your duties and perform them independently. Performance related pay and the opportunity for personal and professional development are of course part of the package. Since 2009 Evonik Industries AG has been certified as a family-friendly company by the German Hertie Foundation. Click on the link to learn more about Evonik from our employees: https://careers.evonik.com/en/about/meet-the-team/ RESPONSIBILITIES Leadership / Functional: Proactively collaborate with stakeholders of various functional groups to prioritize the work for QC to meet the business needs to achieve the best-in-class operation for a Contract Development and Manufacturing Organization (CDMO) Be able to effectively influence and motivate the QC team members to optimize planning and operational activities Identify gaps and define implementation strategies to achieve operational efficiencies and improvements Operational Excellence & Planning: Act as a QC representative to provide operational input for all clients’ projects, including, but not limited to the following responsibilities: Attend routine operational and project meetings, providing QC progress updates to Project Management and the site operational team Bring strategic plans into attainable QC actions to achieve on-time delivery of tasks and projects Communicate status of QC activities to external stakeholders and project-related updates to QC Manager Prepare/revise and manage the QC master schedule / plans (including QC resource allocation and planning) to assure proper alignment with business plan and delivery schedules Support the leading of the QC team to ensure all sample management and testing activities are performed efficiently and effectively, in accordance with approved SOPs, GxP requirements and expectations and EHSS requirements. Sample management includes cross-functional collaboration for RM sampling, arrangement of external testing, as well as communication with those external labs regarding testing requirements and timelines for batch disposition. Draft drug product specification & sampling plans Ensure all stability projects are captured and maintained accurately in the QC system, which includes but is not limited to the following: Prepare stability protocols accurately in accordance with the project requirements for internal and external review and approval in a timely manner Ensure all stability samples are pulled and scheduled for testing within the defined timeframe Support periodic inventory count of all stability samples performed by the assigned QC analyst(s) Perform peer review and approval of QC data related to testing of raw material, in-process, release and stability materials Participate in project(s) and temporary assignment(s) as assigned Quality Compliance: Ensure all data and records are accurate, documented and maintained effectively and in compliance with Good Documentation Practice (GDP) and data integrity requirements Ensure all required training is completed and up to date before performing tasks Where applicable, support the development and update/ revision of applicable SOPs and QC documents in compliance with effective site policies and procedures Participate in OOS, OOT, non-conformance investigation, Change Control, CAPA and Complaint processes Participate in Quality Risk Management activities, as QC SME, as needed Proactively participate in the preparation for internal and external audits (QC audit readiness) Be the subject matter expert (on trained/responsible lab processes) in responding to internal and external audit requests Environment, Health, Safety and Security (EHSS): Adhere to all EHSS programs, rules, and procedures of Evonik Assume personal accountability for individual behaviors related to EHSS activities Have appropriate knowledge, training, and tools (e.g., don applicable PPE) prior to performing the task Complete all required EHSS training and remain current with applicable learning plans Report all near misses/ injuries within the same shift of the incident occurring Inform direct supervisor/ manager of any EHSS hazards or concerns in the workplace REQUIREMENTS BSc. or MSc. in Chemistry, Biochemistry, Microbiology, applied sciences, or equivalent Minimum 5 year’s experience in the parenteral pharmaceutical or biopharmaceutical industry Previous experience in a supervisory role is desirable Experience working in Quality Control, project management, resource planning, and CDMO environment would be an asset Preference for proficiency in real-life application of various program management/ resource planning tools (e.g., LEAN processes, Six Sigma, etc.) to drive operational excellence/ efficiencies Proven time management and organizational skills to work in a fast pace regulated environment and manage multiple projects concurrently Excellent technical writing, problem-solving, and communication skills Detail oriented to ensure accuracy of data and information. Effective and professional interpersonal skills with abilities to collaborate with others across multiple functions Self-motivated with abilities to work in an undefined environment. Flexibility in work hours may be required Proficient in computing (e.g., Microsoft Word, Excel, PowerPoint, Visio, etc.) and performing appropriate data analysis and risk assessment Your Application To ensure that your application is proceeded as quickly as possible and to protect the environment, please apply online via our careers portal. Further information about Evonik as Employer can be found at https://careers.evonik.com. Please address your application to the Talent Acquisition Manager, stating your earliest possible starting date and your salary expectations. Your Talent Acquisition Manager: Robin Rose Company is Evonik Canada Inc. This is your opportunity to join a thriving global organization that combines cutting-edge science, technology and engineering with world-class business services to create solutions that answer real-world problems. If you join us, we’ll expect you to take ownership of your work, team up with other great minds, and add your name to creations that make a positive difference for generations. As one of the world leaders in specialty chemicals operating in more than 100 countries with over 32,000 employees, we need your diversity of thought to make us better. In return for your passion, initiative and creativity, you’ll enjoy opportunities to improve and to be respected for your contribution. Click here to learn more about Evonik from our employees
