SCIENTIST LARGE MOLECULE DRUG PRODUCT DEVELOPMENT

Employer.
      Janssen Research & Development, LLC Job Title.
        Scientist Large Molecule Drug Product Development Job Code.
       A Job Location:  Malvern, PA Job Type.
       Full-Time Job Duties.
Develop and optimize manufacturing processes for protein-based pharmaceutical products including novel drug delivery technology such as long-acting injectable and lipid nanoparticle.
Design, execute, and lead formulation and process development experiments for monoclonal antibodies and other protein candidates.
Studies include, but not limited to, formulation development, process development, stability, robustness, and the development of fill/finish processes.
Lead, facilitate, and participate in technical discussions to successfully resolve problems with suppliers, methods, pipeline program issues, and deviations.
Work independently and in conjunction with appropriate teams to define scientific strategy and to support program/project needs.
Independently lead, design, and perform development and characterization in support of formulation, process, and fill-finish activities for large molecules including mAbs, fusion proteins, bi-specifics, etc.
Author and review documents for regulatory filings (IND, IMPD, BLA, MAA) and internal company use.
Design experiments and provide relevant data to support responses for regulatory agencies minor deficiency letters.
Provide matrix leadership and support people development.
Promote scientific advancement through knowledge of current landscape, external engagement, and industry direction.
Qualifications Requirements.
Employer will accept a Ph.
.
degree in Chemical, Biomedical, Mechanical, Bioengineering, or related engineering field and 3 months of experience in the job offered or in a Scientist Large Molecule Drug Product Development-related occupation.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit  www.
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