Location Collegeville, PennsylvaniaUS
Job ID REQ-053914
Job Responsibilities:
Work as a Process Analytical Technology (PAT) scientist in a multi-disciplinary development team, liaising efficiently with Process Engineers, Formulators, Modellers, automation experts, data scientists and device engineers, to deliver the work packages required to deliver PAT solutions for Steriles drug product development.
Contribute to department PAT strategy, employ new PAT tools for Steriles projects, deploy PAT in R&D and/or Manufacturing plants as per the pipeline need.
Actively participate in technical reviews on projects and ensure timely execution. Contribute to CMC and MPD team planning, agreeing priorities and coordinating PAT activities that support delivery of objectives.
Ensure proper PAT related decisions are taken at appropriate milestones within the project plan to accelerate early phase formulation and process design and API consumption throughout the development life-cycle.
Make innovative contributions to the department by leading PAT platform development workstreams to assess, develop and implement new platforms.
Prepare and deliver Analytics-relevant sections of technical presentations and respond to resulting questions. Identify and escalate Analytics-related risks at scientific reviews.
Enable sound decisions by your influence in matrix teams, through depth of technical knowledge and effective communication, to collaborate actively with R&D Pilot Plants and Global Supply Chain manufacturing sites
Deliver the above in a precise and timely manner, adhering to safety and quality expectations. Comply with the requirements of Quality, Safety and customer policies and procedures and ensure that customer intellectual property is protected.
Maintain training and compliance in areas of health and safety, security, environmental and operational aspects of daily activities in the working environment
Nothing in this job description restricts management's right to assign or reassign duties and responsibilities of this job at any time
Basic Qualifications:
PhD in Chemical Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, Physics, mechanical engineering or any engineering fieldOR
Master's degree in Chemical Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, Physics, mechanical engineering or any engineering fieldwith 3-5 years of similar experience in protein formulation and drug delivery development experience OR
Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, Physics, mechanical engineering or any engineering fieldwith 5-7 years of similar experience in protein formulation and drug delivery development experience
Preferred Experience:
Experience in the application of state-of-the-art laboratory equipment, equipment automation, data automation, PAT tools and data driven modeling for PAT applications.
Experience with commonly used chemometrics packages like Unscrambler, PLS tool box, MatLab, SIMCA
Experience evaluating, developing, and qualifying PAT equipment.
Proven ability to lead and work collaboratively in a matrix style environment
Steriles product development experience
Analytical and physical testing, and data analysis
Demonstration of data integrity principles
Working Environment:
Must be able to work in a laboratory, controlled environments requiring personal protective equipment (e.g., lab coat, safety glasses, etc.) in laboratory
Job pace may be fast and job completion demands may be high
Must be able to remain in a stationary position more than 25% of the time
The person needs to occasionally move between labs, corridors, adjoining rooms, and buildings on-site
Frequently operate on instruments, objects, tools, or controls, which will require regularly bending,
Occasionally move or lift up to 25 pounds (potential for occasional lifting of up to 50 pounds)
Specific vision abilities required by this position include without limitation, the ability to observe details at close range distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus in order to perform the essential service functions of this position
Occasionally operates a computer and other office machinery, such as a calculator, copy machine, and computer printer
Employee may be required to handle hazardous waste according to local, state, and federal regulations
Duties may include identifying, handling, generating, accumulating, storing, and labeling hazardous waste
Potential risk to lab-based hazards including but not limited to extreme temperature, biological materials, and hazardous chemicals
May be required to complete Medical Clearance, Respiratory Protection Training, and Fit Testing to wear a respirator as protection against hazards present in the laboratory environment
The annualcompensation range for this full-time position is $71,240.00 to $106,600.00. The final base pay offered to the successful candidate will be determined by factors including internal equity, work location, as well as individual qualifications, such as job-related skills, experience, and relevant education or training.