Scientist I - Subvisible Particulate

Aptar Italia S.P.A.; Pennsylvania; On-site; USD 51,000 - 65,000; Full time

Job summary

Gateway Analytical is seeking a Scientist I to join our Subvisible Particulate Team in Gibsonia, PA. You will help ensure the quality and safety of pharmaceutical products by counting and sizing particulates using light obscuration, microscopy, or flow imaging, applying compendial methodologies.

The role requires a Bachelor’s degree in a natural science, familiarity with GDP and cGMP, and strong communication.

Qualifications

• 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.

Responsibilities

• Count and size particulates using light obscuration, microscopy, or flow imaging.
• Prepare and analyze samples following established procedures.
• Author reports independently, including signing as author of reports.
• Serve as a technical liaison between sales personnel and customers.
• Maintain quality KPIs and ensure on-time reporting and report accuracy.
• Order and inventory materials to maintain supplies.
• Collaborate with cross-functional teams to ensure GMP compliance.

Skills

Light obscuration counting experience

GDP documentation practices

Excellent communication skills

Detail-oriented

Teamwork and independent work

Education

Bachelor's degree in natural science

Job description

Improving Health through Science and Technology! At Gateway Analytical, an Aptar Pharma company, we specialize 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. Be You, Be Aptar!

What You Will Do at Aptar Pharma

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.

What Aptar Pharma Is Looking For

• 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).

What You Will Bring to the Journey

• 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.
• If you are passionate about analytical chemistry, have a keen eye for detail, and thrive in a dynamic environment, we encourage you to apply. Join us in ensuring patient safety through cutting-edge science and innovation.

Skills

• 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.

What We Offer

• An exciting, diverse and value based working environment
• Award-winning corporate university offering personal development and training opportunities.
• Contribute to the communities where we reside.
• Innovative benefits plan which includes: 401k plan with Company matching benefit, paid time off, medical, dental, vision, life, disability and more

Compensation and Base Annual Pay

Aptar Pharma offers a competitive total rewards package including base salary or base hourly rate determined by many factors including the role, experience, knowledge, skill set and location. For those in eligible roles, discretionary incentive compensation which may be awarded in recognition of individual achievements and contributions.

The typical base annual salary range for the position of Scientist I to the specific work location of: Gibsonia, PA region is USD $51,000 to $65,000 per year. Additional details about total compensation and benefits are provided during the hiring process.

BE YOU, BE APTAR!

Aptar is an Equal Employment Opportunity (EEO) employer. We believe that a diverse workforce is key to our success. We welcome applications from all members of society irrespective of age, sex, disability, sexual orientation, race, religion or belief It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information