Assistant/Associate Scientist

Artech Information System LLC; Village of East Syracuse (NY); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading consulting firm in New York is seeking a Stability Scientist to support its Quality Control Stability program. The candidate will manage stability study administration, monitor stability data, and provide oversight for sample pulls. This role requires a Bachelor's degree in a scientific field, along with 1-2 years of relevant experience. Candidates must have strong communication and problem-solving skills, and familiarity with ICH guidelines and various software tools. Interested candidates should contact for further inquiries.

Qualifications

• Minimum of 1-2 years of relevant experience.
• Ability to prioritize multiple project objectives.
• Work independently and as part of a team.

Responsibilities

• Support program administration and schedule management.
• Draft study protocols and manage study programs.
• Monitor stability data and prepare trend graphs.
• Provide LIMS administration support.
• Maintain stability facility and ensure compliance.

Skills

Knowledge of ICH Guidelines

Problem solving

Interpersonal skills

Oral and written communication

Technical writing

Computer skills (Microsoft Office, SAP, LIMS, Trackwise)

Education

Bachelor’s degree in a scientific discipline

Tools

Microsoft Office

SAP

LIMS

Trackwise

Job description

Position Summary

The role of the Stability Scientist is to support the activities of the Syracuse Quality Control Stability program which includes stability study administration to support site manufacturing; as well as, stability programs for other sites and Third Party Manufacturers (TPM).

Duties/Responsibilities

1. Support program administration by maintaining a schedule of pull dates required for testing, preparing for or providing oversight for the sample pulls as required by schedule.
2. Draft study protocols and support management of study programs as required.
3. Monitor and assess stability data, pull data reports at the end of timepoint testing and prepare trend graphs; Perform data verification and report unusual trends to management for review.
4. Provide Stability LIMS Administration Support for the department, including but not limited to study administration, maintenance, training, etc.
5. Support activities of Stability and Reserve Sample Facility including but not limited to unit maintenance, inventory control, sample receipt and destructions, sample pulls and deliveries, etc.
6. Ensure training requirements are met.
7. Author and/or revise GMP documents.
8. Maintain the office and stability facility in accordance with cGMP.
9. Initiate and promote change as part of operational excellence.

Qualifications

Specific Knowledge, Skills, Abilities, etc:

• Knowledge and understanding of ICH Guidelines (Q1A, Q5C) and associated BMS policies, directives and guidance documents.
• Problem solving ability, interpersonal, oral and written communication skills; as well as technical writing skills.
• Able to prioritize objectives from multiple projects, adhering to scheduled timelines.
• Work independently and contribute to a team based environment; promoting a high commitment to business goals and objectives.
• Computer skills required: Microsoft Office applications, SAP, LIMS, Trackwise, etc.

Education/Experience/ Licenses/Certifications:

Bachelor’s degree in a scientific discipline with a minimum of 1-2 years of relevant experience.

Physical Demands: The physical demands of the job may include but are not limited to: Unassisted lifting of items, not to exceed 50 lbs, Bending/Stooping, Twisting, Crouching/Squatting, Kneeling, Sitting, Crawling, Walking-Level Surfaces, Climbing (Ladder), Reaching (Shoulder), Repetitive (Use of Arm, Hands, Wrists).

Work Environment: The work environment may consist of a combination of the following: Office space, Inside Work, Outside Work, Working Alone, Working with/around others, Extremes (Heat/Cold), Heights, Dust/Mist/Fumes/Wet, Damp/Walking or Work Surfaces, Chemicals.

Additional Information

Interested candidates may contact at "Praveen.arora(@)artechinfo.com or 973-507-7593"