At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Biotherapeutics R&D
Job Category: Scientific/Technology
All Job Posting Locations: Malvern, Pennsylvania, United States of America
Job Description:
About Innovative Medicine:
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.
Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for a Principal Scientist to be in Malvern, PA
Purpose:
Material Sciences is a technical, scientific department within the Therapeutics Development and Supply (TDS) organization. We are expanding our team to strengthen our technical capability around raw materials used in our Biotherapeutics portfolio.
The Analytical Scientist will act as an analytical Subject Matter Expert (SME) and have various responsibilities centered around external analytical development activities.
You will be responsible for:
- Identifying, developing, qualifying, validating, implementing analytical methods for raw materials and related in-process samples (e.g., bioreactor samples and formulations). Support Chemistry, Manufacturing and Controls (CMC) development studies, material qualification, Quality Control (QC) release testing, and investigations.
- Overseeing external method development activities at global network of contract labs (CROs).
- Designing and carrying out experiments in support of analytical characterization of raw materials. Building analytical capability, including evaluation of new instruments and methods. Supporting enhanced characterization and data analysis, including statistical modeling.
- Collaborating within TDS Material Sciences, Active Pharmaceutical Ingredient (API) Protein Upstream and Downstream teams on testing plans. Establish raw materials controls in-process and formulation design.
- Leading method development projects and participate in scientific meetings to share knowledge and foster a culture of scientific thinking. Ensure the accurate and timely preparation of technical reports. Providing guidance toward development of specifications for various materials including cell culture media, resins, excipients, and adjuvants. Aligning analytical controls with global regulatory and GMP guidance.
- Supporting technology transfer of materials used in the clinical and commercial supply chain throughout product lifecycle focused on analytical characterization and methods.
Qualifications / Requirements:
Education:
- A minimum of a Bachelors degree in Chemistry, Biology, Materials Science and Engineering, Biomedical Engineering, Biochemical Engineering, Chemical Engineering, Pharmacy/Pharmaceutics or a related field is required.
- A Masters degree or PhD in Chemistry, Biology, Materials Science and Engineering, Biomedical Engineering, Biochemical Engineering, Chemical Engineering, Pharmacy/Pharmaceutics or a related field is preferred.
Required:
- A minimum of 12 years relevant professional experience is required. This can include some combination of industry and academic experience.
- Demonstrated experience in the development of analytical methods is required.
- Experience leading teams on complex analytical-focused projects is required.
- Experience working effectively with cross-functional teams is required.
- Excellent verbal and written communication skills are required.
Preferred:
- Understanding of product/process (CMC) development, technology transfer, and investigations within the biopharmaceutical industry is preferred.
- Experience in method qualification/validation/transfer is preferred.
- Experience with quality investigations, change control, GxP, and regulatory requirements preferred.
- Experience collaborating with suppliers and contract laboratories is preferred.
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.
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