Senior DP Biologics EngineerScientist

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

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Malvern Pennsylvania United States of America Titusville New Jersey United States of America

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 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 endtoend 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 COGs

• 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 bachelors degree (Biomedical Biochemical Chemical Technology Biotechnology Pharmacy (biological) Engineering; Life Science Technology) or equivalent required; Masters 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

For more information on how we support the whole health of our employees throughout their wellness career and life journey please visit .

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.

Required Skills:

Preferred Skills:

Agile Decision Making Coaching Corrective and Preventive Action (CAPA) Critical Thinking Emerging Technologies Issue Escalation Lean Supply Chain Management Problem Solving Process Control Process Engineering Product Costing Product Improvements Science Technology Engineering and Math (STEM) Application Situational Awareness Technical Research Technologically Savvy Validation Testing Vendor Selection

The anticipated base pay range for this position is :

$94000.00 - $151800.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys 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: - position is eligible to participate in the Companys 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 period10 days

Volunteer Leave 32 hours per calendar year

Military Spouse Time-Off 80 hours per calendar year