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Associate/Scientist I, Quality Control - United States
Posted on : 04 July 2017
- Responsible for contributing to key functional, tactical, and operational aspects of the Global Stability group at our company.
- Ensure compliance and support of company Standards, Practices, and SOPs as well as ICH and FDA guidelines.
- Provide technical expertise and leadership for the stability program of commercial/clinical products.
- This includes design of stability protocols, maintaining data, expiry dating for products, authoring stability sections for submissions, technical assessment of stability specification changes and stability investigations.
- Proficient in understanding of Quality Systems and apply that knowledge in coaching and continuous improvements of systems cross-functionally.
- Ensuring adherence to all regulatory licenses and regulations, serving as a subject matter expert in multiple disciplines, interfacing with key customers.
- Provide technical support during audits/inspections.
- Able to work effectively, independently and within a team framework, across all business areas and levels of the organization.
- This requires excellent written and verbal communication skills.
Responsibilities include but are not limited to:
- Design and manage studies. Independently author stability protocols and collaborate with Sample Control and QC laboratories to ensure proper testing and reporting of stability samples. Manage moderately complex issues, barriers, problems to support team success
- Possess thorough knowledge of methods for data trend analysis and stability data behavior.
- Perform technical review of complex analytical data, interpret data and author in-depth technically-sound stability reports/regulatory submissions independently. Provide technical leadership through effective project management, status tracking, data analysis, presentations, and communication. Approve data/reports for team in the area of discipline/focus.
- Participate effectively in a leadership or membership role for site cross-functional teams as a representative of the Global Stability organization.
- Actively provide leadership and mentoring as needed to aide in the development of team/peers, self and team projects. Represent department in internal and external audits proficiently. Author response to regulatory questions with minimal oversight.
- Contribute to major/critical manufacturing and lead stability investigations (deviations, OOS, cross-site and cross-functional). Independently author stability assessments for Anomalous Results (ARs) and Out of Trend (OOT) stability results. Alert Quality organization about potential issues and evaluate remedial actions.
- Provide innovative solutions to unique complex problems. Proactively identify technical gaps and areas for improvement related to quality or process and lead them through completion.
- Participate on Asset sub-teams and maintain thorough knowledge of CMC program for assigned products.
- Collaborate routinely with other line functions and sites as well as internal/external partners and lead cross-functional teams.
- Advanced knowledge of operations/quality systems/directives and apply the knowledge within the team/project management routinely.
- Excellent technical writing, presentation and oral/written communication skills.
- Author technically sound and highly complex reports, and approve data/reports.
- Provide leadership for complex situations/issues problem solving to effectively reach solution.
- Mature leadership approach and understanding of their personal communication style and manage that effectively.
- Accountable for measurable goals/targets in work area.
- Possess strong organizational skills with ability to multi-task and coordinate multiple activities in parallel.
- Good knowledge of FDA/EMA regulations and compliance.
- Mentor junior members of team in quality systems, process improvements.
- Formulate solutions/options for team and reach out externally to regulatory/global teams for alignment.
- Conduct impact assessment related to compliance (e.g., global directives, audit finding/readiness, deviations).
- Leadership competencies include: Personal Drive, Decision Making, Communication, Building Strategic Work Relationships and Innovation.
- M.S. degree (science preferred), B.S. degree (science preferred), Ph.D as applicable.
- Associate III: 3+ years MS, 5+ years BS, 7+ years AS in comparable role with GMP experience. Leadership experience a plus
- Senior Associate I: 5+ years M.S. and 7+ years B.S. in comparable role with GMP experience. Experience in a Lead role a plus.
- Scientist I: 5+ years Ph.D, 7+ years M.S. and 10+ years B.S. in comparable role with GMP experience and 2+ years technical leadership experience.
- Through cutting-edge science and medicine, our company discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases.
- Our company is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS).
- Our company also manufactures and commercializes biosimilars of advanced biologics.
- Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
- Our company was founded in 1978 and today serves patients in nearly 70 countries.
- We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry.
- To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.
- For nearly two decades our company has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world.
- Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease.
- We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer’s disease, Parkinson’s disease, and ALS.
- As we uncover new insights into human biology, our company is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.
- Our company is revolutionizing biologic manufacturing, developing the industry’s most advanced plants and processes.
- This expertise is used to produce both original innovative therapies and bio similar that expand patient access to lower-cost medicines.
Our Corporate Citizenship
- The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion.
- As a company, we are focused on improving science education and limiting the impact of our company on the environment.
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