Scientist I - Subvisible Particulate

Aptar Group•Richland Township, PA

46d•$51,000 - $65,000•Onsite

About The Position

Gateway Analytical, an Aptar Pharma company, specializes in Drug Delivery offering Innovative Devices, Services and Solutions focused on Patient Experience. Aptar Pharma is part of Aptar Group, a global leader of dispensing systems for the packaging industry. Aptar Pharma has been setting the standard in drug delivery for decades providing health technology solutions and services enabling effective patient treatment. Gateway Analytical is seeking a Scientist I to join our Subvisible Particulate Team. As a Scientist I, you will play a crucial role in helping us ensure the quality and safety of our client’s pharmaceutical products by counting and sizing particulate using light obscuration, manual microscopy, or flow imaging. Your experience with compendial methodologies and their techniques will contribute to our mission to provide industry-leading analytical testing services.

Requirements

Bachelor’s degree in a natural science.
Experience with light obscuration or microscopy counting preferred.
Experience with GDP (Good Documentation Practices) preferred.
Excellent communication skills, both written and verbal.
Detail-oriented, self-motivated, and able to work effectively both independently and in a team.
Able to balance multiple timelines in a fast-paced environment.
A keen interest in a fast-paced scientific learning environment with an emphasis on applying new skills, good written and oral communication skills, vast laboratory equipment knowledge, basic word processing skills, team oriented work ethic, and procedural skills for the use of various laboratory instrumentation.
Data collection, reporting, research, and technical analysis skills necessary.
Critical thinking and problem solving skills.

Responsibilities

Performs and completes all required training elements.
Prepares and analyzes samples in accordance with established and controlled procedures.
Evaluates and interprets data.
Authors reports independently, including signing as author of reports.
Serves as a technical liaison and resource between sales personnel and customers.
Performs quality-related instrumentation and ancillary equipment testing.
Reviews and writes laboratory procedures.
Aids the lab in maintaining quality KPIs including on time reporting and report accuracy.
Orders and inventories materials to maintain supplies.
Communicate and coordinate with instrument vendors when annual service or intermittent service is needed.
Take the lead on documentation and testing as needed for annual preventative maintenance and qualifications of assigned instrumentation.
Aid upper level scientists and management in troubleshooting instrumentation, as needed.
Aid upper level scientists and management in bringing new instrumentation and methods online.
Begin training for technical review of reports when deemed appropriate by management.
Cross-training on different technical offerings if deemed appropriate by management.
Provides training to new associate scientists on ancillary tasks.
Has scientists in training shadow lab work, when deemed appropriate by management.
Aids in audits/communicates with auditors as needed by QA and management.
Comply with all applicable current Good Manufacturing Practices (cGMP) regulations and laboratory safety standards.
Execute particulate counting and sizing analysis for a variety of drug products in compliance with cGMP guidelines.
Author technical documents including test methods, protocols, reports, and procedures.
Aid management in troubleshooting, maintaining, and onboarding new equipment or techniques.
Collaborate with cross-functional teams to ensure compliance with Good Manufacturing Practices (GMP).