.. Spending Account that gives you flexibility to spend where you need It the most. Our Employee & Family Assistance Plan (EFAP) offers you and .. access to various services like counseling, legal advice, mental health Resources etc. We also provide critical illness, disability, and life insurance, as .. read more
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 an excellent Total Rewards Program including:Competitive base compensation & bonus; employer paid health & dental benefits complimented with wellness education sessions; Financial planning resources & savings plans including RRSP & Defined Contribution pension plans; Generous vacation and paid time off to support Community Volunteer activities; Financial assistant for fitness memberships. 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: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 offerExplore a world of opportunities with us. Look ahead with us and help shape innovative solutions to make our world more sustainable and life healthier, more vibrant and more comfortable. At Evonik, you have the chance to explore, thrive, and grow alongside 33,000 colleagues. Among attractive career paths and high-quality development programs, we not only offer performance-based remuneration and occupational health benefits but also hybrid and flexible working environments with #SmartWork. Bring your fresh perspective, develop your strengths, break out your mold, and find a career that fits your dreams with us.Click on the link below to learn what our employees have to say about Evonik:RESPONSIBILITIESEstablish departmental goals and effectively communicate direction, objectives, and results as needed to the department, plant site, and Evonik.Develop and actively manage team conformance to departmental budget, and drive improved efficiencies in departmental operations.Develop, implement and continuously improve the quality system procedures that are effective and compliant to applicable standards.Establish cGMP training systems and perform on-site staff trainingOperate as an independent subject matter expert for the Quality function reporting to Business Line GMP Quality Unit maintaining a business partnership with site manufacturing to ensure delivery of product that meets regulatory and customer requirements.Ensure Vancouver Laboratories meets business and customer requirements with respect to the development and transfer of testing methods for raw materials, in-process controls, and intermediate and final products.Author Quality Agreements between Vancouver Laboratories and clients in accordance with the business lines' rules and guidance.Coordinate and host customer audits and develop audit responses as required by the respective auditing customer.Coordinate and host regulatory agency audits, coordinate follow-up communication and supervise necessary corrective actions on site.Supervise Quality Assurance (QA) and Quality Control (QC) personnel, where applicable through the appropriate managersEnsure appropriate functional leadership and support for internal and external teams (e.g., Corp, Region, etc.).Drive and empower decision making to the lowest level within the organization.REQUIREMENTSM.S. or Ph.D. degree in chemical or biological sciences, pharmaceutical technology, chemical engineering or equivalent experience10 years of experience in GMP manufacturing, Quality Assurance/Quality Control or similar operational areas in pharmaceutical or medical device industry, thereof at least 3 years in a leading position.In depth knowledge of regulatory requirements i.e. GMP, Health Canada, EU and FDA and experience with GMP documentation reviewExperienced with hosting foreign and domestic regulatory inspections (US-FDA, EU authorities)Experienced in hosting customer audits and certification audits (e.g. ISO 9001, ISO 13485)Excellent technical writing and communication skillsSelf-motivated and able to work independently and as part of a teamHigh attention to detail and well-organizedAbility to multi-task in a fast-pace environment with changing prioritiesStrong interpersonal skills with the ability to influence others across multiple functionsExhibits initiative to recognize and solve problemsAbility to apply compliance standards to daily production situation