Principal Scientist, Biotherapeutics Analytical Development

6084-Janssen Research & Development, LLC Legal Entity; Malvern (Chester County); On-site; USD 117,000 - 201,000; Full time

Job summary

Johnson & Johnson is seeking an Analytical Development Scientific Integrator in Biotherapeutics to lead cross-functional analytical programs early in development. You will drive technical strategies for mAbs, multispecifics, and fusion proteins within the AD group and represent Analytical Development on CMC teams.

You will coordinate a matrix of scientists and interact with Manufacturing, Regulatory, Quality, Discovery, and external partners to ensure high-quality regulatory submissions and

Qualifications

• Master1s degree in Analytical Chemistry, Biochemistry, Biological Science or related and 8+ years in biopharmaceutical development.
• PhD in Analytical Chemistry, Biochemistry, Biological Science or related with 3+ years in biopharmaceutical development preferred.
• At least 2 years on cross-functional CMC teams and ability to lead in a matrix environment.
• Knowledge of biotherapeutic development and analytical strategy including analytical protein characterization, separation techniques, and biological potency assays.
• Experience with development and registration of protein conjugates and addressing health authority questions.
• Strong leadership, communication, interpersonal, and negotiation skills with cross-team collaboration.

Responsibilities

• Provide strategic and technical leadership in analytical development and lead a cross-functional AD team.
• Represent AD on the CMC team and accountable for all AD project deliverables.
• Lead the execution of CQA assessment, analytical control strategy, and product specifications for programs.
• Lead analytical reviews of programs at governance meetings with SMEs.
• Accountable for submission of complete, consistent, and high-quality regulatory documents to health authorities.
• Communicate project status/resources/budget/issues to senior management.
• Accountable for project risk management including mitigation strategies and escalation.
• Interact with Manufacturing, Regulatory, Quality, Discovery, and external partners.

Skills

Leadership

Communication

Interpersonal skills

Negotiation

Collaboration

Matrix environment

Education

Master's degree in Analytical Chemistry/Biochemistry/Biological Science

Ph.D. in Analytical Chemistry/Biochemistry/Biological Science (preferred)

Job description

Johnson & Johnson is seeking an Analytical Development Scientific Integrator in Biotherapeutics to lead cross-functional analytical programs early in development. You will drive technical strategies for mAbs, multispecifics, and fusion proteins within the AD group and represent Analytical Development on CMC teams.

You will coordinate a matrix of scientists and interact with Manufacturing, Regulatory, Quality, Discovery, and external partners to ensure high-quality regulatory submissions and