Stability Associate I, Pharmaceutical Development

Employer
Alexion Pharmaceuticals, Inc.
Location
New Haven
Salary
Competitive
Posted
Jan 14, 2018
Closes
Feb 11, 2018
Role
Research
Industry
Chemical
Employer Type
Direct Employer
Employment Type
Permanent
Hours
Full Time
Position Summary

The Stability Associate I is responsible for performing assigned tasks to support stability activities for Alexion's clinical phase biotherapeutic candidates. The Stability Associate I will work in collaboration with members of Analytical Sciences, Pharmaceutical Development, Quality Assurance and other member of GPD as required as well as external vendors.

Principal Responsibilities

* Act as point person for external storage vendor.

* Manage communication for shipments of material between ARIMF, CMO, CRO and test labs.

* Perform data audit and verification for release and stability testing performed by CROs.

* Track and trend stability data from CRO portals.

* Perform sample receipt.

* Maintain stability pull and retention inspection schedules.

* Generate and maintain stability data tables for multiple products; perform data entry and verification.

* Generate and maintain JMP tables as required.

* Generate stability final reports, route for review and approval.

* Write and revise stability protocols, SOPs and PRCs as required, route for review and approval.

* Follow written procedures (PRCs) and stability protocols (QUAs) as well as GMP guidance documents.

* Prepare, review and file testing documentation, and other supporting documents; perform other clerical functions as assigned.

* Perform all job functions in compliance with cGMPs and maintain accurate and legible records.

* Provide stability assessments in support of testing, shipping or storage deviations.

* Ensure training is current for all job functions performed. Attend all required Company training.

* Assist in other Ph. Dev. Stability tasks as trained and assigned.

* Assure quality documents are scanned and archived according to procedures.

Qualifications

* A successful candidate will typically have +2 years' of experience working in a relevant laboratory setting

* Knowledge of GMPs and their application in the environment is preferred.

* Have a strong working knowledge of governing documents for stability.

* Able to understand and follow written procedures.

* Document reported stability data in tables for reporting and trending with a strong attention to detail; able to recognize trends outside of expected results.

* Able to organize his/her own work on a routine basis and requires minimal supervision. When asked, the individual is able to provide updates and tracking on his/her tasks.

* The ability to communicate verbally and in a written format is required.

* Ability to interact with Analytical Sciences Operations groups, Quality Assurance and GPD members.

* Able to navigate external vendor sites and portals for data extraction and review.

* Able to communicate findings to colleagues within the group through presentations.

* Proficient with various MS Office programs, including Word, Excel, Outlook, FirstDocs and PowerPoint as well as SAS JMP statistical software.

Education

* A successful candidate will typically hold a BS degree in Biochemistry, Chemistry, Chemical Engineering or related discipline from an accredited university with 2-5 years' of relevant experience or equivalent combination of education and experience.

* LI-DD1

New Haven, CT, United States

No Selection

Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris? (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion's metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq? (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma? (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.

As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Alexion, please visit or download our App for iPhones and Blackberries.

Alexion is an Equal Opportunity /Affirmative action employer SDL2017

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