Senior DP Biologics Engineer/Scientist

Johnson & Johnson•Titusville, NJ

2d•Hybrid

About The Position

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. 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.

Requirements

A minimum of a bachelor’s degree (Biomedical, Biochemical, Chemical Technology, Biotechnology, Pharmacy, (biological) Engineering; Life Science Technology) or equivalent 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.

Nice To Haves

Master’s degree in Science or Engineering preferred
Proven ability to collaborate and drive outcomes within global, cross-functional, and highly matrixed team environments

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

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
Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.