Senior Engineer, CTTO Vector Lab

Dormont Manufacturing Company

Seattle, WA

JOB DETAILS
SALARY
$124,190–$150,483 Per Year
SKILLS
Analysis Skills, Analytical Development, Asepsis, Biological Processes, Biology, Cell Cultures, Chemical Engineering, Communication Skills, Current Good Manufacturing Practice (cGMP), Disability Insurance, Document Management, Establish Priorities, Experiment Design, GMP (Good Manufacturing Practices), Health Insurance, Insurance, Leadership, Legal Support Skills, Life Insurance, Maintain Compliance, Manufacturing, Manufacturing/Industrial Processes, Marketing, Microsoft Office, Minitab, Operational Improvement, Operations Processes, People Management, Performance Analysis, Pharmacy, Presentation/Verbal Skills, Problem Solving Skills, Process Development, Process Engineering, Process Improvement, Process Validation, Product Support, Production Support, R Programming Language, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Reporting Skills, Root Cause Analysis, Statistics Software, Support Documentation, Team Lead/Manager, Technical Drawing, Technical Leadership, Technical Operations, Technical Support, Technical Writing, Testing, Time Management, Validation Plan
LOCATION
Seattle, WA
POSTED
2 days ago

The Senior Process Engineer in Cell Therapy Technical Operations (CTTO) will play a key role in ensuring successful manufacture of life‑saving cell therapy products. The primary focus is to support testing and implementation of operational improvements and resolve manufacturing process investigations at the BMS cell therapy GMP manufacturing facilities. The Senior Process Engineer will lead, design and execute experiments, evaluate data, and draft technical reports in support of improvements, investigations, and manufacturing process changes. They will also contribute to well‑controlled comparability and validation studies that enable regulatory filings for raw material and process changes. Additionally, the role may lead a group of engineers and provide leadership and technical guidance. The Senior Process Engineer partners with cross‑functional groups and serves as a subject‑matter expert (SME) on processes, equipment, and compliance issues in manufacturing.ResponsibilitiesLead, manage, design, execute, and support experiments in the CTTO DP & Vector labs which include aseptic processing and operation of automated process equipment.Partner with cross‑functional groups and teams and lead technical projects and discussions.Manage and oversee junior engineers on performance, studies, and review technical reports and investigations.Summarize experimental data and aid in analysis to draw conclusions.Lead or participate in Root Cause Analyses (RCA) to determine cause of manufacturing process investigations.Coordinate with the analytical group for timely delivery of process samples and turn‑around of analytical data.Lead or support production‑related investigations, ensuring compliance with internal standards and regulatory requirements.Lead, develop, and execute manufacturing process changes and improvement activities, and/or author technical reports for process changes and improvements.Lead or support process characterization, process comparability and process validation studies including planning, execution, and documentation management. Support necessary technical experiments and analysis to enable decisions related to raw materials changes.Contribute to ownership and advancement of work processes, and procedures.Work flexibility with occasional cell culture experiments on weekends and evenings.Required QualificationsDegree in Biological Sciences, Chemical Engineering, Life Sciences, or related discipline.BS degree with minimum of 7+ years of relevant experience, or MS degree with minimum 4+ years of relevant experience in biologic process/analytical development or commercial biologic manufacturing process support.Excellent documentation skills and diligence with cGMP experience a plus.Ability to effectively lead and work in cross‑functional teams, meet deadlines, and prioritize responsibilities.Experience working in a self‑driven, performance/results oriented, fast‑paced matrix environment.Excellent critical thinking skills.Able to creatively manage time and elevate relevant issues to project lead and line management.Strong scientific and technical writing with excellent oral communication skills.Preferred QualificationsCombination of experience in cell therapy process development, Global MS&T, Site MS&T, and Quality. Proficiency utilizing MS Office products and working knowledge of statistical software (example: R, JMP, Minitab).Experience executing investigations in support of commercial manufacturing.Experience with commercial product support, i.e., post‑marketing commitments, ongoing validation, and comparability.Leadership experience with managing teams and direct reports.Operational excellence training/background.Compensation OverviewSeattle – WA: $124,190 – $150,483. The starting compensation range(s) for this role are listed above for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job‑related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.BenefitsHealth Coverage: Medical, pharmacy, dental and vision care.Well‑being Support: Programs such as BMS Well‑Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).Financial Well‑being and Protection: 401(k) plan, short‑ and long‑term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support and survivor support.Eligibility for specific benefits listed on our careers site may vary by job and location. For more on benefits, please visit BenefitsPaid Time Off: US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays; Pacific Office adjustments). Non‑Exempt and hourly employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.Additional time off options: unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs. Annual global shutdown between Christmas and New Year's Day.Equal Employment OpportunityBMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ProtectionWe will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.ContactR1602494: Senior Engineer, CTTO Vector Lab#J-18808-Ljbffr

About the Company

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Dormont Manufacturing Company