Senior Principal Scientist, Global Process Development, Drug Product Development & Delivery

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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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 are searching for the best talent for a Senior Principal Scientist Global Process Development Drug Product Development & Delivery to be onsite in Malvern PA.

Purpose:
The Senior Principal Scientist Global Process Development (GPD) Drug Product Development & Delivery (DPDD) a department in the Therapeutic Development and Supply (TDS) organization functions as a scientific subject matter expert providing guidance on process development scale-up and technology transfer for parenteral fill-finish manufacturing across various biologics assets. They will also work and partner with colleagues in MSAT quality regulatory and other functions to ensure the implementation of manufacturing processes that meet all regulatory requirements and expectations.

You will be responsible for:

• Establish and maintain to industry standards and best-practices internal capabilities for biologics drug product process development scale-up and technology transfer.
• Lead process development scale-up technology transfer process validation and health authority submissions for biologics drug products.
• Partner with MSAT manufacturing site leads quality regulatory and other functions for flawless introduction of manufacturing processes into production sites in accordance with pertinent regulatory guidelines.
• Design of experiments supporting rigorous control strategies and aligned with regulatory expectations.
• Scientific data interpretation and critical report review of global process development studies.
• Lead best product and process at launch right first time and other process development and technology transfer harmonization/optimization initiatives.
• Participate in issue-resolution teams through active engagement in scientific discussions and the shaping of strategies designed to support and inform critical development decisions.
• Contribute to the success and growth of DPDD through active participation in internal and external committees / working groups and closely interact with scientists in other functional areas including formulation development drug delivery systems analytical development drug substance development and CMC project leaders in the US EU and China.
• Management of direct reports

Qualifications / Requirements:

Education:

• Minimum of a Bachelors degree is required
• PhD in a technical field (e.g. Chemical Engineering Pharmaceutical Science Biochemistry) is highly preferred
  

Required:

• Minimum of 8 years of experience developing and commercializing parenteral biologic drug product processes.
• Technical expert on current manufacturing processes and equipment and engineering scaling principles with the ability to apply knowledge to technology transfer and process optimization aligned with HA-guidelines and GMP regulations.
• Prior experience in scientific data evaluation statistical analysis budget management across multiple complex programs and scientific writing.
• Strong written and verbal communication skills and the ability to negotiate and influence decision-making processes think and manage issues to resolution and contribute to study teams and scientific discussions
• Personal leadership skills a pro-active and flexible attitude sense of urgency and excellent collaboration and inclusive team relationships skills
• Ability to travel to support development and manufacturing activities at CMOs CRLs and internal sites in US and EU (up to 15% travel project dependent)

Preferred:

• Minimum of 4 years of experience developing and commercializing parenteral bioconjugate drug product processes (liquid and lyophilized).
• Direct experience developing and commercializing drug product processes for antibody-radionucleotide-conjugates
• Experience with written regulatory interactions in support of drug development

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 & 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 external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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