Scientist, Biologics Analytical R&D (On-site

Position: Scientist, Biologics Analytical R&D (On-site)
Location: North Wales

** Job Description*
* Join a team dedicated to advancing lifesaving and life-enhancing medicines through exceptional scientific oversight of our company's biologics portfolio from development through commercialization. Grounded in ethics, integrity, transparency, and scientific rigor, we bring together diverse perspectives to deliver transformative medicines.

We are seeking a  
** Scientist (R2)
** to join our  
** Biologics Analytical Research & Development (AR&D) GMP Operations
** team in  
** North Wales, PA, part of the West Point campus footprint** . The ideal candidate brings strong technical judgment, GMP discipline, and cross-functional collaboration skills to support biologics development and commercialization.

The successful candidate will execute testing of compendial and separations-based analytical methods, including HPLC, UPLC, CE, and iCIEF.  The incumbent will collaborate with Analytical Development, Large Molecule Assay Validation, Quality Assurance, Technical Operations, CMC Regulatory Affairs, and external stakeholders to validate analytical methods and support release and stability testing.

** Responsibilities*
* + Validate and implement analytical methods to support release and stability testing of clinical materials.

+ Execute Good Manufacturing Practices (GMP) activities such as release, stability, and in-process testing of Biologics Drug Substance (DS) and Drug Product (DP).

+ Act as subject matter expert (SME) across various franchises and analytical platforms.

+ Support biologics registrations, product launches, and troubleshooting activities.

+ Support compliance audits, inspection activities, and investigation/CAPAs.

+ Author and review technical documents.

+ Complete assigned work within established project timelines.

+ Ensure adherence to GMP standards and facilitate ongoing enhancement of laboratory processes.

+ Manage laboratory equipment, laboratory supplies and critical reagent inventories.

+ Support instrument qualification activities, including IQ/OQ/PQ, as needed.

+ Additional responsibilities as assigned to support the evolving needs of the department.

** Qualifications*
* + Minimum of a B.A./B.S. degree in biology, biochemistry, or related scientific field with 3 years of relevant experience in analytical development, validation, and/or quality control, or M.S. degree with a minimum of 1 year of relevant experience.

** Experience and Skills*
* ** Required*
* + Minimum of 1 year experience working in a GMP environment

+

Experience with separation techniques such as HPLC, UPLC, CE, iCIEF, or other advanced technology.

+ Proficiency with data analytics.

+ Understanding and adherence to ALCOA principles for documentation.

+ Strong organizational skills and ability to manage work to meet project timelines.

+ Capability to work independently with minimal supervision.

+ Ability to identify and resolve common technical issues.

+ Effectively engage, communicate, and collaborate with others.

+ Self-motivated with a positive attitude, strong interpersonal skills, and aptitude for learning.

+ A willingness to occasionally work irregular hours, including evenings and weekends, to support business needs.

**​Preferred*
* + Technical expertise with compendial testing such as visible and sub-visible particles, pH, osmolality, color, and/or clarity.

+ Knowledge of USP, EP, ICH, and FDA regulations.

+

Experience with LIMS, Empower, electronic notebook, and/or other data analytics platforms.

+ Knowledge of deviation management and change control processes.

ARD

EligibleforERP

*
* Required Skills:

*
* Adaptability, Analytical Laboratory, Analytical Method, Biochemistry, Data Analytics, Good Manufacturing Practices (GMP), High-Performance Liquid Chromatography (HPLC), Laboratory Processes, Laboratory Techniques, Project Management, Separation Sciences, Standard Operating Procedure (SOP) Writing, Technical Writing, Troubleshooting, Ultra Performance Liquid Chromatography (UPLC)

** Preferred

Skills:

*
* Analytical Method Development, Method Validation

Current Employees apply HERE ($6687.htmld)

Current Contingent Workers apply HERE ($4020.htmld)

** US and Puerto Rico Residents Only:*
* Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  ()  if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  

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