Jobs for People with MS: National MS Society

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:

US004 PA Malvern - 200 Great Valley Pkwy

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 Senior Scientist, CMC Comparability to be in Malvern, PA.

Purpose: The Senior Scientist will apply an understanding of protein chemistry and characterization to drive comparability studies in the context of the chemistry, manufacturing, and controls (CMC) requirements for biologics. Specifically, the candidate will coordinate all aspects of comparability studies resulting from drug substance and drug product process changes for new molecular entities in clinical development or for commercial products. The successful candidate will also develop, design, and perform mass spectrometry assays in support of product characterization and process development activities.

You will be responsible for :

• Write protocols, reports, and coordinate testing across functional groups.

• Effectively communicate comparability plans and results to management review committees and representation on cross-functional project teams.

• Write analytical sections of regulatory submissions.

• Design and execute LC/MS assays for characterizing antibody and non-antibody products (mAb and non-mAb products).

• Maintain laboratory notebooks and prepare written protocols and reports in a Good Manufacturing Practice (GMP) compliant manner.

Qualifications / Requirements:

Education:

• Bachelor’s degree is required

• Master’s degree or PhD is highly preferred

Required:

• Minimum of 10 years of experience following the completion of a Bachelor’s Degree OR minimum of 5 years of experience following the completion of a Master’s Degree OR minimum of 0-2 years of experience following the completion of a PhD in Analytical Chemistry, Biochemistry, Biotechnology, Protein Formulations, Chemical Engineering, or a related field

• Strong knowledge of protein chemistry and characterization experience with protein physicochemical characterization methods (reverse-phase, ion-exchange, size-exclusion HPLC, cSDS/SDS-PAGE, cIEF/IEF, mass spectrometry, CD, AUC, or DSC)

• Hands-on experience with Mass Spectrometry

• Experience working in a GLP/GMP environment

• Experience performing and managing complex studies

• Ability to balance and contribute to multiple project priorities

• Ability to independently work across other functions (regulatory, QC, process development) to drive studies

• Good written and verbal communication skills

Preferred:

• Experience performing comparability studies or characterization studies to establish biosimilarity

• Experience with characterization of antibody drug conjugates (ADCs)

• Experience working with protein stability studies for comparison of degradation profiles

• Experience with LC/MS peptide mapping methods and analysis software to identify and quantitate post-translational modifications

• Experience and understanding of pharmaceutical development chemistry, manufacturing and controls (CMC) processes and regulatory requirements for protein biologics

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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