Senior Specialist, Stability Operations - Hybrid

Job Description

Senior Specialist, External Capabilities Validation & Compliance (Stability Operations), Analytical Research & Development

The Analytical Research & Development (AR&D) Stability Operations & Compliance department of our company Research Laboratories Division is seeking applicants for a stability operations senior specialist position available at our US research facilities. 

The Stability Operations Senior Specialist will work as a part of the integrated Stability Operations & Compliance team and drive a culture of quality and operational excellence across the global AR&D network. The Stability Operations Senior Specialist will oversee and manage GMP stability studies and logistics for our large molecule portfolio in collaboration with our AR&D scientists.

The key responsibilities of this role will include:

• Management of GMP stability studies, including detailed planning, coordination across networks, and implementation of stability studies for the large molecule portfolio, in accordance with all applicable regulatory requirements.

• Collaboration with internal and external partners in a cross-functional environment to drive compliance and operational excellence for stability studies.

• Evaluation of stability data, including statistical analysis and trending, investigating out of specification stability results, and communication with integrated project teams for biologics, vaccines, and/or devices.

• Maintain accurate records including sample inventory and sample chain of custody, leveraging digital systems (e.g., LIMS, Benchling, electronic notebook, electronic document management systems).

• Analytical sample management support for large molecule pipeline stability study activities including: aliquoting, labeling, distribution to testing laboratories, and shipping.

• Execute deviations and investigations, Change Management records, manage GMP documentation including stability protocols, Standard Operating Procedures (SOP), and GMP data management.

Candidates should be able to function independently and be able to collaborate in a dynamic, integrated, multidisciplinary team environment.  Effective communication skills, eagerness to adapt and learn, and a desire to conduct research and influence the field are essential attributes.  As a member of our team, you will be joining scientific problem solvers who are dedicated to creating the life-changing medicines of tomorrow.

Education Minimum Requirements (standard for each level):

• M.S. with 3+ years of post-degree relevant industry experience or B.S. with 7+ years of experience.

Required Experience and Skills:

• Knowledge and understanding of regulatory guidance and quality standards applicable to stability testing and shelf-life determination of vaccines and/or vaccines.

• Working knowledge of analytical methods and GMP policies and procedures.

• Experience working within a GMP environment.

• An effective collaborator with the ability to work both independently and in a cross-functional team setting to deliver on complex objectives.

• Proven track record of strong technical and innovative problem solving.

• Desire and ability to learn new concepts outside of core expertise and training.

• Excellent communication skills, demonstrated creativity, and effective interpersonal skills.

• Related industry experiences supporting management of stability studies.

Preferred Experience and Skills:

While not required, experience in one or more of the following areas is beneficial.

• Experience leading teams for a common goal.

• Experience supporting internal and external quality audits.

• Experience with LIMS.