Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for an Assistant/Associate Scientist for our client in East Syracuse, NY.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
The role of the Assistant Stability Scientist is to support the activities of the Global Biologic Stability program which includes stability study administration to support commercial biologic network.
- Draft study protocols and support management of study programs as required.
- Author and/or revise stability procedures in a GMP environment.
- Monitor and assess stability data via periodic trending systems. Prepare appropriate trend presentation for further evaluation, highlighting and escalating potential data issues.
- Support the generation of project specific trending, reports, and presentation directed toward investigations, periodic review, protocol conclusions, etc.
- 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.
- Provide stability electronic systems administration support for the department, including but not limited to LIMS study administration, Discovernant hierarchy development support, training, etc.
- Interact with and provide support activities to the designated stability storage facility including but not limited to inventory control, sample receipt and destructions, sample pulls and deliveries, temperature monitoring, etc.
- Ensure training requirements are met.
- Maintain the office and stability facility in accordance with cGMP.
- Initiate and promote change as part of operational excellence.
- Bachelor’s degree in a scientific discipline with a minimum of 4 years of relevant experience.
- Knowledge and understanding of ICH Guidelines (Q1A, Q5C) and associated Client policies, directives and guidance documents.
- Strong technical writing skills with an attention to detail
- Problem solving ability, interpersonal, oral and written communication skills with the ability to escalate issues in a timely manner.
- 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, JMP (or other stability trending systems, like Excel), etc.
If hired, you will enjoy the following Eclaro Benefits:
Interested in applying? Contact Joy Retanan at Joy.Retanan@eclaro.com now.
- 401k Retirement Savings Plan administered by Merrill Lynch
- TransitChek Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.