Job Function:
Discovery & Pre-Clinical/Clinical Development
Job Sub Function:
Biological Research
Job Category:
Scientific/Technology
All Job Posting Locations:
Malvern, Pennsylvania, United States of America, Spring House, Pennsylvania, United States of America
Job Description:
We are searching for the best talent for our
Scientist, Biologics Analytical Development Proteins position to belocated in Malvern, PA or Spring House, PA.
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.
You will be responsible for:
- 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.
Qualifications/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.
- 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.
#LI-Hybrid
Required Skills:
Preferred Skills:
Accelerating, Analytical Reasoning, Clinical Data Management, Critical Thinking, Data Analysis, Data Reporting, Data Savvy, Design of Experiments (DOE), Drug Discovery Development, Issue Escalation, Molecular Diagnostics, Pharmaceutical Microbiology, Product Knowledge, Research Proposals, Scientific Research, Standard Operating Procedure (SOP), Technologically Savvy
