Scientist, Biologics Analytical Development Proteins
About The Position
We are searching for the best talent for our Scientist, Biologics Analytical Development Proteins position to be located in Malvern, PA or Spring House, PA. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine Purpose: The Scientist, Biologics Analytical Development (AD) Proteins is responsible for supporting chamber monitoring readiness, Yokogawa panel replacement activities, change control execution, and financial planning within Biologics AD. This role ensures operational continuity, compliance, timely record management, and sound budget oversight through close collaboration with facilities, quality, finance, project management, and site stakeholders.
Requirements
- Bachelor’s degree in Science, Engineering, Finance, Business, or a related field is required with at least 4 years of industry experience OR a Master’s degree /MBA (or equivalent degree) with at least 2 years of industry experience OR PhD with 1 year of industry experience.
- Experience supporting change control, quality systems, or regulated operations in a pharmaceutical, biotech, or related environment is required.
- Strong understanding of operational coordination, compliance processes, and record management is required.
- Experience with budgeting, forecasting, variance analysis, and financial reporting is required.
- Ability to manage multiple priorities and coordinate activities across cross-functional teams is required.
- Strong analytical, organizational, and problem-solving skills are required.
- Strong written and verbal communication skills are required.
- Proficiency in Microsoft Office applications, including Excel, Word, PowerPoint, and OneNote, is required.
- Experience developing reports, dashboards, or performance metrics is required.
Nice To Haves
- Experience with COMET or similar electronic change control systems is preferred.
- Experience with chamber monitoring, facilities coordination, or equipment change activities is preferred.
- Knowledge of NC/CAPA processes and compliance reporting is preferred.
- Experience with data visualization tools such as Power BI, Tableau, or Spotfire is preferred.
- Ability to identify process improvements and drive standardization is preferred.
- Project management experience in development or commercial operations is preferred.
Responsibilities
- Maintaining and verifying chamber monitoring tracking information and confirming readiness for routine and quarterly monitoring activities.
- Reviewing and supporting change controls related to chamber updates and Yokogawa panel replacements, including coordinating assessments, approvals, and communication of monitoring gaps.
- Partnering with chamber owners, facilities, and service providers to support monitoring readiness, equipment status, and required documentation.
- Serving as a business lead and subject matter resource for COMET change control processes, including supporting user adoption, issue resolution, system testing, process improvements, and stakeholder communication.
- Acting as a single point of contact for assigned change controls, including pre-change planning, record assignment, assessment initiation, follow-up, board review coordination, approvals, extensions, amendments, and closure tracking.
- Maintaining reports, dashboards, and periodic updates for change controls, NC/CAPA activities, investigations, action items, and compliance metrics.
- Supporting monthly financial close and reporting activities, ensuring accurate and timely financial information.
- Developing and managing capital and expense budgets, forecasts, scenario planning, and variance analyses.
- Monitoring project performance against forecasts, updating budgets during planning cycles, and supporting on-time, within-budget execution.
- Building dashboards, analyzing performance trends, and providing insights to support financial, operational, and strategic decision-making.
- Collaborating with Finance, Operations, PMO, Supply Chain, Quality, and scientific teams to improve planning, controls, standardization, and execution.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
