FULL_TIME

FEED

OTHER

Promote positive relationships and collaboration with Process Development functional leaders, data sciences, Janssen Supply Chain leaders, Quality Assurance, and Discovery. •Contribute to technical forums both internal and external to the company to share knowledge and approaches related to deep product characterization strategies as they relate to cell and gene therapy products. •Optimally communicate comparability study plans, statistical justifications, and results and scientific data to cross-functional teams, project teams, and health authority as needed.

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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&DJob Category: Scientific/TechnologyAll Job Posting Locations: Malvern, Pennsylvania, United States of AmericaJob 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-medicineWe are searching for the best talent for a Principal Scientist, Analytical Comparability & Product Characterization - Advanced Therapies to be in Malvern, PA.Purpose:The Biotherapeutics Development - Analytical Development (BioTD - AD) group is seeking an upbeat, highly motivated Principal Scientist to focus on analytical comparability and product characterization for advanced therapy modalities. The individual would work with team to develop product comparability study approaches for advanced therapy modalities that will be endorsed by the health authorities. A successful candidate will have experience with the design, execution and optimization of a broad range of characterization assays and will have the opportunity to engage in multi-functional teams. They will learn from and contribute to industry-leading drug discovery/development programs that has brought numerous quality therapeutics to patients and has made significant contributions to human health.Primary Responsibilities: •Design and lead the execution of analytical comparability studies for advanced therapy modalities across various stages of development. •Lead the execution of the advanced methodologies associated with comparability and deep characterization of cell and gene therapy. •Author or coordinate appropriate IND/IMPD/BLA/MAA sections & interact with regulatory agencies to address CMC-comparability and product characterization related inquiries. •Optimally communicate comparability study plans, statistical justifications, and results and scientific data to cross-functional teams, project teams, and health authority as needed. •Collaborate to develop innovative approaches to challenging solutions for analytical comparability strategy and product characterization. •Promote positive relationships and collaboration with Process Development functional leaders, data sciences, Janssen Supply Chain leaders, Quality Assurance, and Discovery. •Contribute to technical forums both internal and external to the company to share knowledge and approaches related to deep product characterization strategies as they relate to cell and gene therapy products. •Identify/collaborate with partners in academia or industry to implement innovative ideas or characterization approaches. •Stay up to date with industry standards, guidelines, and regulatory requirements related to Advanced therapies, comparability studies and product characterization. •Author comprehensive reports and presentations to communicate findings and technical data to internal and external collaborators. •Champion the development and enhancement of standard operating procedures (SOPs) for comparability assessments.Qualifications: Required: <ul><li>Ph.D. or equivalent advanced degree in Biochemistry, Immunology, Virology, Biological Science, or a related field with 3+ years of proven experience in biopharmaceutical development; OR a BS or MS with 6-8 years of experience of overall experience is required.</li><li>2+ years of analytical control strategy experience on advanced therapy medicinal products (ATMP) such as CAR T, lentiviral vectors and gene therapy products.</li><li>Familiarity with Quality by Design (QbD) principles and their application in comparability assessments.</li><li>Experience with the design, execution and optimization of a broad range of analytical techniques for the characterization of cell therapy and gene therapy products.</li><li>Must be detail-oriented, highly organized and able to manage multiple tasks, handle tight timelines and deliver quality data</li><li>Strong written and verbal communication skills with the ability to convey complex scientific concepts clearly.</li><li>Mentor and guide junior scientists and technicians in experimental design, data interpretation, and quality assurance practices.</li><li>Excellent interpersonal skills with the ability to operate effectively in a dynamic work environment is required.</li><li>Ability to work collaboratively in a complex, matrix environment</li></ul> Preferred: <ul><li>Understanding of the connections between clinical, process/product development, and biological outcomes</li><li>Experience with regulatory submissions and interactions with agencies such as the FDA or EMA.</li><li>Previous experience in project management or leading cross-functional teams is a plus.</li><li>Proficiency in statistical analysis and equivalency assessment is a plus</li></ul>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.

<img alt=" " height="1" src="https://ars2.equest.com/?response_id=c74a9ed25a810c77a52e573c5af31aac&view" width="1"/>

Caring for the world, one person at a time... inspires and unites the people of Johnson&nbsp;&amp;&nbsp;Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson&nbsp;&amp;&nbsp;Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

Our Family of Companies comprises:

 The world’s sixth-largest consumer health company. 
 The world’s most comprehensive medical devices business. 
 The world’s sixth-largest biologics company. 
 And the world’s fifth-largest pharmaceuticals company. 


We have more than 265 operating companies in more than 60 countries employing approximately 126,500 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

Johnson and Johnson

Principal Scientist, Analytical Comparability & Product Characterization – Advanced Therapies

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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. 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.

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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&DJob Category: Scientific/TechnologyAll Job Posting Locations: Malvern, Pennsylvania, United States of AmericaJob 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-medicineWe are searching for the best talent for a Principal Scientist to be in Malvern, PAPurpose: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: <ul><li>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.</li><li>Overseeing external method development activities at global network of contract labs (CROs).</li><li>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.</li><li>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.</li><li>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.</li><li>Supporting technology transfer of materials used in the clinical and commercial supply chain throughout product lifecycle focused on analytical characterization and methods.</li></ul> Qualifications / Requirements:Education: <ul><li>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</li><li>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</li></ul> Required: <ul><li>A minimum of 12 years relevant professional experience is required. This can include some combination of industry and academic experience.</li><li>Demonstrated experience in the development of analytical methods is required.</li><li>Experience leading teams on complex analytical-focused projects is required.</li><li>Experience working effectively with cross-functional teams is required.</li><li>Excellent verbal and written communication skills are required.</li></ul> Preferred: <ul><li>Understanding of product/process (CMC) development, technology transfer, and investigations within the biopharmaceutical industry is preferred.</li><li>Experience in method qualification/validation/transfer is preferred.</li><li>Experience with quality investigations, change control, GxP, and regulatory requirements preferred.</li><li>Experience collaborating with suppliers and contract laboratories is preferred.</li></ul>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.#LI-Hybrid<img alt=" " height="1" src="https://ars2.equest.com/?response_id=74df142d8ab88bcb20f1ee3d5bac1909&view" width="1"/>

Principal Scientist, External Analytical

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Principal Scientist, Analytical Comparability & Product Characterization – Advanced Therapies Johnson and Johnson

Principal Scientist, External Analytical Johnson and Johnson

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