Senior DP Biologics Engineer/Scientist Full-time

Drug Product Technical Owner (TO)

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.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Are you interested in joining a team that is passionate about groundbreaking operations that improve the lives of patients? Do you want to work for an employer with an excellent record in employee continuous professional development and business improvement? Apply today for this exciting opportunity!

As a Drug Product (DP) Technical Owner (TO) within Global MSAT, you will serve as the end-to-end scientific and technical authority for a designated product or portfolio. Acting as the MSAT voice within the Value Chain Team (VCT), you will lead the technical strategy, lifecycle management, and continuous improvement of commercial drug product processes, ensuring sustained compliance, robustness, and supply reliability across internal and external manufacturing networks.

Key Responsibilities:

• Represents MSAT and the technical team in the Value Chain Team (VCT) and provides the required manufacturing technical support
• Provide onsite technical support and guidance to CMOs during Tech Transfers and/or Deviation resolutions, representing the MSAT voice
• Serve as the SME and single point of accountability for DP technical aspects across the product lifecycle
• Define and drive the technical lifecycle management strategy, including process robustness, performance monitoring, and continuous improvement
• Supports the VCT to identify improvement/innovation opportunities, to build project business cases and to prioritize projects (product related)
• Owns the coordination of all product-related technical activities
• Monitors technical process and product performance
• Identifies and implements opportunities for active decrease in manufacturing COG's
• Implements or follows-up on execution of technical projects
• Deploys the platform standardization policy as appropriate
• Supports failure investigations (escalation of quality or compliance events)
• Reviews technical product & process risk profile and criticality analysis
• Implementing and supporting new platforms innovations or changes in life cycle management products
• Provides this expertise as well to External Manufacturing related to the Biotherapeutics Platform
• The successful candidate will be an integer person with a high level of self-awareness and adaptability.
• Proven leadership in providing integration of activities and information across multifunctional groups and matrix teams
• Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through the various matrix teams
• Ability to influence peers, superiors, and partners
• Understands the technical aspect of the lifecycle strategy of products
• Applies the science-based risk approach and regulatory intelligence
• Understands culture differences

Qualifications

Education:

• A minimum of a bachelor's degree (Biomedical, Biochemical, Chemical Technology, Biotechnology, Pharmacy, (biological) Engineering; Life Science Technology) or equivalent required; Master's degree in Science or Engineering preferred

Experience and Skills:

Required:

• Minimum 5 years of progressive experience in sterile/aseptic biologics drug product manufacturing within a GMP-regulated environment, or Process Development/Research or Tech Transfer Experience
• Scientific background in engineering or life sciences (or similar) or experience in the respective field.
• Proven ability to lead and influence cross-functional, matrixed teams across MSAT, Manufacturing, Quality, Regulatory, and Supply Chain with a high degree of autonomy and ownership
• Ability to provide technical leadership for post-approval changes, tech transfers, validation activities, and process improvements
• Deep understanding of GMP, regulatory expectations, and lifecycle management frameworks
• Experience with process performance monitoring and Continued Process Verification (CPV), including data trending, statistical analysis, and identification of improvement opportunities
• Demonstrated ability to apply science-based, risk management tools (e.g., FMEA, risk assessments) to support robust decision-making and regulatory compliance
• Strong business acumen with experience identifying and delivering COGs reduction, process efficiency, and standardization initiatives
• Excellent written and verbal communication skills with the ability to translate complex technical data into clear, actionable insights for senior stakeholders and cross-functional teams
• Advanced proficiency in data analysis, problem-solving, and digital tools (beyond MS Office), with a focus on data-driven decision-making and continuous improvement
• Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.

Preferred:

• Proven ability to collaborate and drive outcomes within global, cross-functional, and highly matrixed team environments

Other:

• Ability to travel as needed to maintain a strong on-site MSAT presence at J&J and CMO partner sites (North Carolina and Indiana), with flexibility to respond to short-notice, time-critical technical and project demands

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 https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is:

$94,000.00 – $151,800.00

Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). The following link to general company benefits information MUST also be included in the posting: Please use the following language: For additional general information on Company benefits, please go to: – https://www.careers.jnj.com/employee-benefits This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time – 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time – up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period 10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year