Scientist - Container Closure Integrity And Compendia Support

Scientist Position

We are seeking a growth and improvement-minded Scientist that can help drive our strategic operating priorities. Our focus areas include:

• Invent | Pursue the most promising internal and external science to address significant unmet medical needs
• Execute | Prioritize resources behind our key growth drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) while optimizing our base business
• Adapt | Develop our people, culture, and business model to evolve with a dynamic landscape
• Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
• Values and Standards | Our steadfast commitment to our values and standards will continue to guide us as we take on new challenges and will always be fundamental to our success – they are a competitive advantage for us

The position will focus on Container Closure Integrity testing (CCIT) and compendial testing, including method optimization, testing, troubleshooting, analytical tech transfer or verification, and analytical procedure lifecycle (APLC) management. The successful candidate will interface with our QC partners across our company network and external partners to provide SME support where needed. There will be ample opportunities to get cross-trained and work on other technologies such as ICP-MS and ICP-OES.

Key Responsibilities

• Function as an analytical subject matter expert (SME), troubleshooting and optimizing analytical methods, with a focus on Container Closure Integrity methods and compendial methods.
• Collaborate with cross-functional teams to ensure successful tech transfer of analytical methods between QC labs.
• Provide technical leadership and mentorship to junior scientists and team members.
• Participate in Large Molecule Analytical Procedure Lifecycle (APLC) activities across various franchises and analytical platforms.
• Support various biologics and vaccine post-marketed CMC regulatory submissions.
• Lead strategic initiatives within departmental and cross-functional teams representing GQLMAS.

Minimum Education Requirement

• Bachelor of Science (B.S.) or Master of Science (M.S.) in Mechanical Engineering, Biomedical Engineering, Industrial & Systems Engineering, Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field/discipline with 2-4 years of relevant work experience in current Good Manufacturing Practices (cGMP) laboratory environment.

Required Experience | Knowledge | Skills

• Relevant analytical execution, development, validation, and/or quality control (QC) as it pertains to Vaccines and/or Biologicals.
• Knowledge in Container Closure Integrity Testing or compendial testing.
• Ability to learn new techniques, troubleshooting assays, author and review technical documents.
• Excellent organizational skills to manage multiple projects.

Preferred Experience | Knowledge | Skills

• Hands-on experience in CCIT method development, validation, and troubleshooting for injectable therapeutics. Familiar with the following CCIT technologies for this purpose: dye ingress, high voltage leak detection, vacuum and pressure decay, laser headspace analysis.
• In-depth expertise with compendia testing such as visible particles, subvisible particles, color, clarity, pH, osmolality, extractable volume, content uniformity, and water content. Familiar with relevant chapters in EP, JP, and USP.
• Knowledge or experience in GMP.
• Good technical, communication (oral and written), interpersonal, and teamwork skills.
• Ability to effectively identify and communicate risks.
• Experience with other analytical methodologies.