Senior Scientist, Biologics Analytical Research & Development

About this role

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:
• Education Minimum Requirement:
• 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:
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• Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a
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