Lead Analytical Development Scientist, Biotherapeutics

Johnson & Johnson Co.; Malvern (Chester County); On-site; USD 117,000 - 201,000; Full time

Benefits offered by this job

Long-term incentive program

Consolidated retirement plan (pension)

Job summary

Johnson & Johnson, in Malvern, PA, seeks a Principal Scientist for Analytical Development in Biotherapeutics. You will lead cross-functional teams, manage CMC deliverables, and drive analytical strategies for monoclonal antibodies and protein conjugates.

You will shape regulatory documents, communicate with senior management, and collaborate across Manufacturing, Regulatory, and Quality to ensure high-quality program outcomes.

Qualifications

• A minimum of a Master's degree in Analytical Chemistry, Biochemistry, Biological Science, or a related scientific discipline with at least 8 years of experience in biopharmaceutical development is required.
• A Ph.D. in Analytical Chemistry, Biochemistry, Biological Science, or a related scientific discipline with at least 3 years of experience in biopharmaceutical development is preferred.
• A minimum of 2 years of experience on cross-functional CMC teams or analytical sub-teams with the ability to lead and execute complex plans/deliverables in a matrix environment is required.
• Knowledge of biotherapeutic development and analytical strategy including analytical protein characterization, separation techniques, and biological potency assays is required.

Responsibilities

• Provide strategic and technical leadership in analytical development and lead a cross-functional scientific team consisting of members from each of the AD sub-functions.
• Represent AD on the CMC team and accountable for all AD project deliverables.
• Lead the execution of critical quality attribute (CQA) assessment, analytical control strategy, and product specifications for programs.
• Lead the analytical review of programs at governance meetings with support from subject matter experts.
• Accountable for submission of complete, consistent, and high-quality regulatory documents to health authorities.
• Effectively communicate project status/overview, resources, budget, and issues to senior management.
• Accountable for project risk management including development of appropriate mitigation strategies and escalation to senior management.
• Interact with and influence various stakeholders outside of DPDS including Manufacturing, Regulatory, Quality, Discovery, and external partners.

Skills

Leadership

Communication

Interpersonal skills

Negotiation

Education

Master's degree in Analytical Chemistry/Biochemistry/Biology or related

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

Job description

Johnson & Johnson, in Malvern, PA, seeks a Principal Scientist for Analytical Development in Biotherapeutics. You will lead cross-functional teams, manage CMC deliverables, and drive analytical strategies for monoclonal antibodies and protein conjugates.

You will shape regulatory documents, communicate with senior management, and collaborate across Manufacturing, Regulatory, and Quality to ensure high-quality program outcomes.