Senior Engineer Process Validation
New York City, New York
Expiry Date :
Sun, 06 Dec 2020 23:59:59 GMT
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At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMSs continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible. Bristol Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results. PURPOSE AND SCOPE OF POSITION: Reporting to the Sr Principal Engineer within Global Manufacturing Science and Technology, this is a key role that will help define and implement the process validation framework for Celgenes cell therapy products. The Sr Engineer is responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply. The scope will range across all cell therapy products in the portfolio, internal and external manufacturing processes/facilities Cell Therapy drug product. The role will provide technical oversight for initial process performance qualification (PPQ) as well as throughout the product life cycle. The candidate will participate in execution activities across the network to ensure expertise is integrated centers throughout the network and our process validation standards and master plans represent the continuous learning from the manufacturing experience. The position will develop (or co-develop) documentation (including plans, protocols, risk assessments, etc.), coordinate study/validation execution and create process validation strategies for Cell Therapy Process Validation satisfying internal and external regulatory expectations. He/she will perform independent execution of validation activities required for the production operations to ensure rapid, compliant, and cost-effective delivery of quality products. This role will also develop following: process validation standards, process qualification strategy and framework for cell therapy processes, continuous process verification (CPV) strategy and implementation in a consistent manner across products and sites. Candidate will interface with Site MSAT and other validation counterparts in the Celgene Biologics and small molecule network to leverage expertise and knowledge across modalities. The candidate will also contribute to the significant process validation issues, troubleshooting efforts and responses to emerging requirements or questions during health authority interactions. Candidate will participate in, review, approve the development of process characterization and process control strategies as needed to ensure that the control strategies are consistent with the process validation standards and manufacturing requirements. Candidate may supervise a small team of 1-3 subject matter experts and/or contractors in support of peak execution activities. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities: Education and Experience: – Required Bachelors Degree in Life Sciences or Chemical Engineering – Minimum 6 years of experience in pharma/biotech industry, min 3-5 years of validation experience in a GMP environment DUTIES AND RESPONSIBILITIES: – Develop and implement validation policies to define robust process validation program within the cell therapy product lifecycle. – Participate in generation and approval of PPQ enabling deliverables generated during late stage process development and characterization. – Define process validation strategy for upcoming products and support PPQ execution in a multi-site commercial environment. – Author/Support CMC content for regulatory filings and participate in formal agency meetings. – Represent validation on contract manufacturing projects, including vendor selection, process transfer and process validation. Direct responsibility for validation activities at contract manufacturing organizations, including validation gaps assessments during CMO selection and tech transfers – Provide oversight via review and approval of site level deliverables, including Validation Master Plans, process validation protocols and risk assessments. – Design qualification strategies to support novel applications of fill, filtration, sterilization and single-use disposable technologies – Develop and implement continuous process monitoring strategies and ensure process validation status throughout commercial lifecycle – Respond to site independent process validation troubleshooting issues, questions – Coordinate responses to health authority questions on process validation that require a coordinated response or implementation across cell therapy manufacturing. – Work with process, analytical development and MSAT groups to review, approve the development of process characterization and process control strategies as needed to ensure that the control strategies are consistent with the process validation standards and manufacturing requirements. – Author, review and approve, as needed, various validation documents including, but not limited to, protocols, PPQ plans, final reports and process validation master plans WORKING CONDITIONS (US Only): The position will work in an office environment and will need to write complex documents and final reports using a computer. This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management. If you want to challenge yourself, accelerate your career, and give new hope to patients, theres no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today. BMSCART Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.