Senior Scientist, Biologics Analytical Development Full-time NEW

Senior Scientist, Biologics Analytical Development

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

We are searching for the best talent for a Senior Scientist, Biologics Analytical Development role to be in Malvern, PA. You will be responsible for:

• developing, validating, and transferring biochemical methods in accordance with ICH Q2(R2) and Q14, focusing on capillary electrophoresis (CE) and HPLC methods for biopharmaceutical product characterization and quality control.
• serving as the analytical technical expert during method development, regulatory filings, and inspections.
• fostering strong collaborations while maintaining a focus on customer needs.
• innovating and implementing cutting-edge approaches for analytical method development.
• providing deep analytical expertise for programs from early-phase to late-phase clinical development and commercial manufacturing.
• analyzing and communicating complex data succinctly and clearly.
• leading continuous improvement initiatives for methods, processes, and scientific procedures.
• writing, reviewing and approving validation/transfer protocols, technical reports, SOPs and present data to peers and functional management.
• authoring/reviewing relevant sections of regulatory filings including INDs, IMPDs and BLAs, addressing inquiries from the health authorities
• contributing to laboratory operations improvements, enhancing efficiency and GMP compliance.
• serving as an Instrument owner and manage instrument maintenance and qualification

Qualifications / Requirements:

Education:

• a minimum of a Bachelor's degree is required
• a PhD or Master's degree is highly preferred

Required:

• a minimum of 2 years experience in the pharmaceutical/biotech industry or post-doctoral experience is required
• Proven scientific expertise with extensive hands-on experience in protein isolation and separation techniques, including electrophoresis and chromatography is required
• First-author publication is required
• Exceptional planning and tracking abilities with a results-oriented mindset, adept at managing multiple projects while respecting priorities and resources is required
• Excellent organizational, communication, and presentation skills, combined with strong scientific and technical writing abilities are required
• Demonstrated ability to collaborate effectively in a fast-paced team environment and quickly acquire new technical skills is required

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource. A pre-identified candidate for consideration has been identified. However, all applications will be considered.