Scientist, Regulatory Cmc Dossier – Biotherapeutics

Description

Janssen Research & Development , L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for a Scientist, Regulatory CMC Dossier - Biotherapeutics based in Spring House, PA.  Remote work options may be considered on a case-by-case basis and if approved by the Company.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.

We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at  www.janssen.com  and follow us @JanssenGlobal.  Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

Authors/drives, as appropriate, sections of the CMC dossier and evaluates/ensures that final versions comply with regulatory requirements and fulfill regulatory agency expectations with managerial guidance. The Scientist supports the technical functions in the development of responses to health authority inquiries in support of clinical trials as well as assists the team lead in preparing responses to marketing applications with managerial guidance. Evaluates and ensures the completeness, accuracy, and compliance of data provided for all regulatory submissions with managerial guidance. Ensures all Quality submissions are completed in a timely manner.

Responsibilities

• Lead and execute CMC writing for clinical applications (CTA, IND) and may participate in marketing applications (BLA, MAA) for biologics
• Support the CMC functional subject matter experts in the development, authoring, and editing of CMC related technical data for inclusion in Modules 2 and 3 of the eCTD
• Lead CMC team meetings to resolve reviewer comments on the regulatory dossiers, execute dossier updates and meet regulatory timelines
• Prepare, review, manage, and lead responses to CMC related questions from regulatory authorities
• Perform reviews of dossier documents prepared by other team members for completeness, accuracy, and structure
• Work closely with Regulatory Affairs, Analytical Development, API Process Development, Drug Product Process Development, and External Stakeholders to communicate document-specific timelines to team members to ensure timely deliverables
• Resolves cross-functional issues
• Works mostly independently on a day-to-day basis

Qualifications

Qualifications

• Ph.D. with 0-2 years of relevant experience is required, OR Bachelors or Masters degree with at least 4 years relevant experience is required
• Regulatory CMC writing experience in pharmaceutical biologics (cell and/or gene therapy a plus) is preferred
• Understanding of process validation, process development, and process characterization within product life cycle management is preferred
• Growing understanding of regulatory requirements for complex biologic products, as well as experience authoring IND and BLA filings is preferred
• Desire and ability to learn and grow is preferred
• Excellent written and oral communication skills with the ability to work collaboratively and independently across international teams is preferred
• The ability to be a strong collaborator and great teammate is preferred
• Ability to work in a fast-paced environment and connect with different functional groups and people at multiple levels is preferred
• Strong communication and personal leadership skills, pro-active and flexible attitude, sense of urgency, excellent collaborator is preferred
• This position is based in Spring House, PA, however remote work options may be considered on a case-by-case basis and if approved by the Company.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

The anticipated Compensation for this role is $ 104,000 - $166,750. The Company maintains highly competitive, performance-based compensation programs.  Under current guidelines, this position is eligible for an annual performance bonus.  The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year.  Bonuses are awarded at the Company’s discretion on an individual basis.  Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans.  Additional information can be found through the link below.

Information on benefits can be viewed by following this link:  https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States.  Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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.