Cmc Modeling Engineer Jobs

Past Management Experience is a MUST

Will work and manage in-house and outsourced lab activities

Experience working amongst CMC leaders such as Regulatory, Analytical, and Quality

Experience overseeing outsourced vendors (CMOs/CDMOs)

Experience overlooking multiple drug candidates within the company's pipelines

M.S. or Ph.D. in Pharmaceutical Sciences or a related scientific field with ideally 10-15 years of industry experience

Develop and manage budgets for CMC operations, ensuring cost-effectiveness while maintaining high-quality standards

Forecast and manage the supply of drug product for clinical trials

A minimum of 10-12 years experience in pharmaceutical or biotechnology CMC development with regulatory interactions experience

Excellent cross-functional leadership, team building, and communication skills

Proven experience in tech transfer, manufacturing scale-up, and validation of biotechnology products

Hiring Manager Interview (45 minutes)

Generate innovative concepts for new technologies using numerical techniques and identify potential research areas which would benefit new technology development.

Analyze results, summarize findings, and communicate these to managers and directors in engineering, manufacturing, and R&D.

Develop models to enable virtual simulation of PPG processes using data from the manufacturing plant and theoretical sources.

Work with external resources to advance modeling capability, expand capacity and accelerate model development.

Proficiency in using ANSYS CFD or Star-CCM+ for process modeling; Aspen Plus and/or ACM-based chemical process modeling expertise is appreciated.

Ability to use statistical tools such as JMP to analyze data from various sources.

Demonstrated experience supporting a running production facility

Experience with P&IDs, I/O lists, and other process design documentation

Working knowledge of at least one of the following: DeltaV, Experion, Siemens PLC, Beckhoff PLC, Allen-Bradley PLC

Working knowledge of AspenPlus and HYSYS

Prior experience developing a digital twin

Experience with the following industries and production environments:

Clinical experience and great customer service skills.

Medical knowledge in pediatric patients and vaccines.

The LVN is responsible for the direct and indirect care of the clinic patients.

The LVN assists the physician and/or mid-level provider providing care to patients.

Minimum of 8 years of water modeling experience.

Experience using InfoWater software is required

The Water Modeling Engineer duties and responsibilities will include, but are not limited to:

Project Partners provides professional benefits to its employees.

Develop water system models and assist in master planning.

Perform process design calculations and technical analysis.

BS in a quantitative or scientific discipline with 4+ years of relevant data science/analytics experience in the pharmaceutical industry

Experienced with computer languages (R, Python, SQL, etc.) and statistical software packages (JMP, Statistica, Minitab, etc.) to manipulate and analyze data

Experienced with business informatics tools (e.g. Tableau, Power BI, Spotfire)

Prior experience working in a GMP environment and understanding of bioprocessing unit operations is a must

Drive and support data pipeline initiatives

Engage with the delivery of new process analytics tools cross-functionally

Microsoft Project (or equivalent project management software) and Microsoft Office skills

At least 2-years of experience as a project manager

10-years of experience in the Pharmaceutical, Biotechnology or Biomedical related field, direct CMC experience is highly desirable

Facilitation and soft skills to work with cross functional teams

Critical thinking and problem-solving skills

Develop and use project plans and schedules to measure and report progress.

Ensure teams active, aligned communication in functional and cross-functional management reviews and governance meetings

Job Title: CMC Project Manager - Remote

Establish and manage collaboration and team sites. Track delivery and create repositories for all PD deliverables

Assist PD in driving decision making and communication

Pay Rate: $70/hr to $75/hr

Apply project management expertise across the portfolio for standard and complex projects, managing multiple projects in parallel.

Strong knowledge of biopharma industry. Familiarity/experience with end-to-end CMC drug development.

Report on project progress, offer viable solutions and opportunities as they arise

Work with internal and external stakeholders to manage project deliverables, e.g., CMOs, Supply Chain, etc.

Excellent interpersonal, communication, and presentation skills.

Strong leadership skills and executive presence; ability to positively influence outcomes.

A minimum of years of engineering experience.

Strong oral and written communication skills.

Skilled with Object Oriented Programming Languages such as C/C++ and Python

Experience with data and statistical analyses

Lead and advance technology readiness levels for CMC process models.

Develop and execute CMC roadmaps that support component durability, performance, and cost out.