Senior Scientist, Biologics Analytical Research & Development Full-time

Senior Scientist (R3) in Biologics Analytical Research & Development (AR&D) GMP Operations

We invite individuals who possess a deep passion for promoting lifesaving and life-enhancing products to join our dynamic team. Our team is highly dedicated and committed to offering exceptional scientific oversight, driving the success of our Company's extensive range of products from candidate selection to market authorization. At our company, we proudly continue to build upon a legacy of groundbreaking innovation while steadfastly upholding the highest standards of ethics and integrity. With a workforce representing a multitude of languages and cultures, we stand unified in our collective mission to deliver revolutionary medicines and products with integrity and transparency.

We are actively seeking an enthusiastic individual to join our North Wales, PA team as a Senior Scientist (R3) in Biologics Analytical Research & Development (AR&D) GMP Operations, to support ELISA and cell-based potency methods. In this role, the selected candidate will be responsible for phase-appropriate validations, late-stage transfers, SoftMax Pro template validations, analytical life cycle management, troubleshooting, and release and stability testing. The successful candidate must be able to work in a fast-paced, multidisciplinary environment and will play a pivotal role supporting Biologics to advance commercialization efforts.

The incumbent will collaborate closely with various stakeholders, including Analytical Development, Large Molecule Assay Validation, Quality Assurance, Technical Operations, and CMC Regulatory Affairs, to address technical challenges, provide scientifically sound guidance at each stage of development, and effectively manage deliverables to progress the pipeline.

Responsibilities:

• Execute Good Manufacturing Practices (GMP) activities such as release, stability, and in-process testing of Biologics Drug Substance (DS) and Drug Product (DP) using both traditional and advanced analytical tools.
• Validate and implement analytical methods to support release and stability testing of clinical materials.
• Support critical reagent qualifications and SoftMax Pro template validation activities.
• Act as subject matter expert (SME) across various franchises and analytical platforms.
• Support biologics registrations, product launches, and troubleshooting activities.
• Develop and manage project timelines and deliverables.
• Support compliance audits, inspection activities, and investigations/CAPAs.
• Advance strategic initiatives across matrixed teams.
• Document activities in a detailed and organized manner following ALCOA principles and SOPs.
• Author and review technical documentation including regulatory submissions.
• Additional responsibilities as assigned to support the evolving needs of the department.

Position Qualifications:

• Bachelor's degree in biology, biochemistry or related science with 7 years of relevant experience in analytical development, validation, and/or quality control (QC)
• Master's degree in biology, biochemistry or related science with 3 years of relevant experience in analytical development, validation, and/or quality control (QC)
• PhD in biology, biochemistry or related science

Required Experience and Skills:

• Experience in the area of large molecules (vaccines, biologics) immunochemical and cell-based analytical methods.
• Deep technical expertise with ELISA and cell-based potency methods.
• Proficiencies with mammalian cell culture.
• Experience with residual ELISA methods.
• Strong organizational skills with proven ability to manage timelines and deliverables.
• Ability to proactively identify and communicate risks.
• Demonstrated capability of finding innovative solutions to technical issues.
• Capability to work independently and within a matrixed team.
• Effective communication (oral and written) and leadership skills.
• Strong interpersonal skills with adeptness to lead by influencing others.
• Self-motivated with a positive attitude and proven performance record.
• Willingness to occasionally work irregular hours, including evenings and weekends, as needed.
• Experience with deviation management and change control processes.

Preferred Experience and Skills:

• At least 1 year experience working in a GMP environment.
• Experience with LIMS, SoftMax Pro, electronic notebook, and/or other data analytics platforms.
• Knowledge of cGxP operation, USP, EP, ICH, and FDA guidelines.
• Experience with analytical method validation and life cycle management.
• Experience with method development or regulatory submissions.
• Experience with SoftMax Pro template creation is highly preferred.
• Experience with qPCR or compendial methods is desirable.

Required Skills:

Adaptability, Analytical Method Development, Analytical Validation, Assay Development, Bioanalytical Analysis, Biochemical Assays, Biochemistry, Cell-Based Assays, Enzyme Linked Immunosorbent Assay (ELISA), GMP Compliance, GMP Environments, Good Manufacturing Practices (GMP), Immunoassays, Immunochemistry, Immunotherapy, Innovative Thinking, Mammalian Cell Culture, Potency Assays, Self Motivation, Strategic Thinking, Technical Writing

Preferred Skills: