Senior Principal Scientist, Bioanalytics

Job Description

The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) Department of our company's Research Laboratories seeks an experienced scientist to join our Regulated PK & ADA Bioanalytical group in West Point, PA.  The position requires demonstrated strategic leadership and expertise in the bioanalysis of bio/therapeutics and immunogenicity assessment.   In this position, you are an exceptional scientific leader with responsibilities that include but are not limited to the following:

• Provide strategic guidance for preparing high-quality bioanalytical-related regulatory documentation, including IBs, IND, NDA, BLA, ISI, background packages, regulatory responses, F2F regulatory interaction meetings, and other scientific and regulatory documents to support global clinical trials and registration.

• Provides strategic scientific leadership and oversight on immunogenicity of peptides and biotherapeutics

• Provide bioanalytical scientific oversight for all modalities in the pipeline, including small molecules, peptides, monoclonal antibodies, fusion proteins, ADCs, and cell & gene therapy molecules

• Guide development of bioanalytical methods for the quantitation of drug candidates using ligand binding assay (LBA) based platforms, LC-MS, and other emerging technologies

• Provide strong drug development mentorship and partnership in problem-solving with internal and external partners such as CROs

• Represent the department on project teams in support of programs in development including bioanalytical strategies but not limited to

Education Requirements:

• PhD in immunology, biological sciences, or a related field with a minimum of 15 years of relevant experience

Required Experience and Skills:

• Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment

• Expert-level experience in regulatory interactions

• Considered an expert in immunogenicity   

• Expert-level experience with regulatory processes, applicable regulatory guidelines, and Good Laboratory Practice (GLP).

• Experience supervising and/or mentoring junior and senior scientists

• Strong scientific acumen with demonstrated expertise in all phases of nonclinical and clinical drug development

• Strong leadership skills and ability to work to maintain effective interactions and influence strategic direction through collaboration with various stakeholders

• Efficient organizational skills and excellent verbal and written communication skills

• Prior experience preparing bioanalytical sections of regulatory submissions, as well as experience interaction with regulatory agencies

• Deep understanding of anti-drug antibody (ADA) components of peptides and biologics, including immunogenicity risk assessment and immunogenicity data interpretation

• Well recognized in the bioanalysis space, having significantly contributed to global regulatory strategy through scientific publication and/or participation in external consortia/collaborations with proven ability to influence industry trends and regulatory policy concerning immunogenicity.

• Proven strategic and leadership skills.

Preferred Experience and Skills:

• Experience in cell-based assays.

• Experience in cell & gene therapy

• Experience in vaccine bioanalysis

This position will be at WP PA sites and is an on-site position.

Current Employees apply HERE

Current Contingent Workers apply HERE

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 click here 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 r