Principal/Senior Principal Engineer MS&T Gene Delivery and Editing
: Job Details :

**Principal/Senior Principal Engineer MS&T Gene Delivery and Editing**

CAROUSEL_PARAGRAPH

* Seattle, Washington; Summit, New Jersey; Warren, New Jersey

* Drug Dev and Preclinical Studies

* R1550435

* Full Time

* 12/17/2021

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At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In 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.

BMS is looking for a Senior Principal Engineer/Principal Engineer to join the Manufacturing Science and Technology Gene Delivery and Editing department. The position will be responsible for the routine MSAT support to our US CMO partners. This engineer will have responsibilities like an internal MSAT organization for BMSs viral vector manufacturing and fill sites with the focus on supplementing the technical capabilities of the CMO and driving continuous improvement. This person may be responsible for and support processes including PPQ, commercial launch, and commercial manufacturing support.

The Process Engineer will support product lifecycle management, including commercialization and evolution of cell therapy products as well as day to day operations technical support at CMOs to ensure reliable quality supply. The role will be highly cross-functional and will interact with other groups and in-country affiliates in establishing manufacturing and technology capability, CMO selection, facility fit and design, equipment selection, and facility start up work force training.

**Key Responsibilities**

**These include, but are not limited to, the following:**

* Provide remote technical troubleshooting support for manufacturing activities at external manufacturing locations and when needed, provide on-site technical process support of ongoing manufacturing processes.

* Create and revise technical documentation (e.g. changes controls, SOPs, and batch records)

* Perform deviation investigations and corrective and preventive actions (CAPA) as a technical resource. Author technically challenging deviations and drive them towards closure.

* Provide data collection, interpretation, and analysis on manufacturing and manufacturing support processes. Determine areas of opportunity, shifts and trends, and states of control

* Collaborate with cross-functional teams, including the CMO joint process team, Process Development, Manufacturing, Quality Assurance and External Manufacturing.

* Performing process fit-to-plant, equipment characterization and scale-up, process Failure Modes and Effects Analysis (FMEA)-based risk assessment, creation of Process Flow Diagrams and Bill of Materials, review and approval of production Master Batch Records.

* Perform detailed review of Process Development processes and generate technology transfer documents, including process monitoring (manufacturing data analysis, summary, and presentation) and authoring campaign summary reports.

* Responsible for the successful transfer of viral vector processes into GMP production.

* Assist with validation and startup activities that may include authoring PPQ protocols and reports, providing process training to support implementation of new technologies and specifications as well as process changes.

* Develop simulated process models to estimate throughput capacity, resources and inventory levels.

**Required Qualifications**

* OpEx and Lean Six Sigma project experience is strongly preferred

* Extensive experience in a regulated GMP manufacturing environment (clinical and/or commercial)

* Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects.

* Experience in development and/or characterization of biologics and/or cell therapy manufacturing processes.

* Experience with cGMP, ICH guidelines, PPQ (process validation), and working with a Quality organization.

* Experience working in a self-driven, performance/results oriented, fast paced matrix environment.

* Experience or knowledge of creating computer-based process models using process simulation software.

* Experience or knowledge of statistical analysis using statistical software package.

* Able to creatively manage time and elevate relevant issues to project lead and line management.

* Strong scientific and technical writing.

* Detail oriented with excellent verbal and written communication skills.

* Ability to travel domestically and internationally.

**Qualifications & Experience**

* MSc or BSc in Chemical Engineering, Biochemical Engineering or equivalent with 10+ years of relevant experience in process development or commercial manufacturing.

* Knowledge of CAR-T and/or lentiviral vector manufacturing a plus.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to ...@bms.com . Visitto access our complete Equal Employment Opportunity statement.

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