Job Number: 19-11247
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for an Assistant/Associate Scientist for our client in New Brunswick, NJ.
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 Associate Scientist is to perform activities related to the global stability studies to support both premarket and market life stability programs.
- Activities include those associated with the Global Stability program which includes coordinating receipt of stability samples, label generation, sample storage, time point pulls, shipment to testing labs, inventory management and reconciliation to support Client manufacturing as well as stability programs for third party manufacturers (TPM), as applicable.
- Oversees and supports stability team by ensuring a schedule of pull dates with contract storage and testing facility(ies), preparing for or providing oversight for the sample pulls as required by schedule, unit maintenance, inventory control, sample receipt and destructions, sample pulls and deliveries, inventory management and reconciliation.
- Assists with review of stability data and trends.
- Support stability program activity execution for the current and new products.
- Engage with generation of sample management program and logistics, master stability protocol, stability study protocol. Review stability study LIMS build for accuracy with respect to sample management.
- Identify, write and revise applicable SOPs for managerial review and approval.
- Write applicable technical reports section for sample storage and sample management pull information for OOS/OOT investigations as needed.
- Escalate information regarding stability program management that may impact lab capacity, product studies or regulatory commitments directly and promptly to management.
- Provide team training need for ongoing stability activities.
- Ensure training requirements are met.
- Works according to cGMP requirements and HA expectations.
- Can effectively interact with inspectors during facility tours.
- Knowledge of science generally attained through studies resulting in a BS/MS Degree or equiv. preferably in Biological Sciences.
- Minimum of 4 years (MS)/ 6 years (BS) relevant experience (biopharm or related Laboratory) at an Associate Scientist 1 Level (at Client or other company).
- A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to quality control laboratories in a biologics manufacturing facility.
- Experience in interpreting and applying cGMPs, USP, regulatory requirements and industry best practices.
- Proficient with US/EU Requirements and industry best practices; develops strategies for solving complex problems/issues with coaching. Use computer software/programs: Microsoft Office applications, SAP, LIMS, Trackwise, etc.
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Maria Castañeda | LinkedIn
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.
Job Status: Contract/Temporary