MSAT Bio DS Scientific Director Fellow

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:

Manufacturing Engineering

Job Category:

People Leader

All Job Posting Locations:

Horsham Pennsylvania United States of America Malvern Pennsylvania United States of America Wilson North Carolina 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 are searching for the best talent for a MSAT Bio DS Scientific Director/Fellow to join our Team! This is an onsite/hybrid role.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to align with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):

Pennsylvania & North Carolina USA- Requisition Number: R-076959

Netherlands & Ireland- Requisition Number: R-077368

Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.

Job Description

Fellow / Scientific Director

Manufacturing Science & Technology Biotherapeutics Drug Substance (MSAT Bio DS)

Location: Malvern US; Cork Ireland; Leiden The Netherlands (with global scope)

Role Overview

The Manufacturing Science & Technology (MSAT) Biotherapeutics Drug Substance organization is seeking a Fellow / Scientific Director to provide scientific and technical leadership ensuring the compliance resilience competitiveness and lifecycle robustness of Johnson & Johnsons commercialized and latestage biologics portfolio.

This role provides leadership across value optimization late lifecycle management and complex global DS activities operating across products sites and functions. The Fellow / Scientific Director is expected to bring deep scientific expertise strong systems thinking a collaborative and innovative attitude and influential leadership to drive robust technical decisions innovative solutions and sustained manufacturing performance across the global MSAT Bio DS network.

Key Responsibilities

Scientific & Technical Leadership

• Acts as a recognized internal and external subject matter expert with direct impact on scientific and business objectives.

• Provides scientific leadership across drug substance development commercialization and lifecycle management with strong understanding of the impact of process parameters on product quality attributes.

• Defines and shapes scientific strategy for programs projects and technologies ensuring technically sound and innovative approaches are embedded into business application.

• Proactively shapes control strategies for commercial and latelifecycle biologics DS processes owning platform alignment.

Collaboration Across MSAT Sites & Global Teams

• Works in close partnership with MSAT site teams and global MSAT functions ensuring strong alignment between site execution and global technical strategy.

• Actively fosters crossMSAT collaboration across platforms (e.g. Launch & Growth Value Optimization Labs Material Sciences) enabling sharing of best practices harmonized standards and accelerated learning.

• Builds strong trustbased partnerships with Operations Quality R&D Regulatory Planning PES and external manufacturing partners to drive integrated rightfirsttime delivery across the network.

• Promotes a OneMSAT attitude strengthening collaboration between sitebased and global teams to deliver consistent highquality outcomes.

Lifecycle Value Optimization & Network Impact

• Leads technical and scientific activities across value optimization and late lifecycle portfolios including investigations continuous improvement initiatives and complex lifecycle changes.

• Identifies assesses and resolves highimpact complex and crossfunctional scientific and technical issues establishing clear decision points and riskbased paths forward.

• Creates manages and prioritizes multiple complex programs and projects delivering highquality outcomes aligned with business objectives.

• Actively partners with R&D organizations to translate development knowledge into robust MSAT processes and manufacturing solutions. Provide feedback to development from CPV trends and manufacturing lessons learned.

Innovation & FutureReady Mindset

• Brings a strong innovative attitude actively seeking new concepts technologies and approaches to improve process robustness efficiency and sustainability.

• Champions harmonization digital enablement advanced analytics and new ways of working to futureproof DS manufacturing and lifecycle management.

• Encourages scientific curiosity continuous improvement and thoughtful challenge of the status quo to deliver longterm value for patients and the business.

Regulatory Compliance & External Interaction

• Is accountable for postapproval submissions and contributes to health authority interactions.

• Leads the preparation and review of regulatory documents presentations and responses acting as senior scientific author and reviewer.

• Maintains current knowledge of global regulatory guidelines and health authority expectations related to biologics drug substance.

Leadership Talent & Capability Development

• Leads and mentors scientific and technical talent across MSAT Bio DS acting as a technical role model and mentor.

• Has indirect people leadership responsibility including matrix teams outsourced activities and external partners.

• Drives development of intellectual capital continuous learning and capability building within the function.

• Actively seeks opportunities to improve business processes scientific rigor and operational excellence.

Communication & Influence

• Communicates overall scientific and technical strategy clearly across site and global forums.

• Serves as a key liaison between project teams MSAT leadership senior business partners and crossfunctional partners.

• Influences across functions and senior leadership through scientific credibility and collaborative leadership.

• Negotiates and builds alignment around new ideas approaches and concepts through sound scientific reasoning.

Program & Project Leadership

• Contributes to budget and resource allocation for programs and projects.

• Sets and monitors priorities timelines resources and risks across complex technical portfolios.

• Influences the initiation development and termination of projects to ensure optimal scientific and business outcomes.

• Advises on existing procedures and assesses opportunities for improvement across products and processes.

• Directs appropriate introduction and implementation of new technologies to ensure longterm competitiveness.

Qualifications

Required:

• Masters degree or PhD in Chemistry Biochemistry Biotechnology Chemical Engineering or related field (or equivalent experience).

• Minimum of 12 years of experience in biotherapeutics drug substance development and/or manufacturing including people leadership experience.

• Indepth experience in proteinbased therapeutics including process development analytics and scaleup.

• Proven experience authoring and reviewing CTA and BLA submissions.

• Strong track record of leading complex scientific and technical teams in a global matrixed environment.

Preferred:

• Excellent written and verbal communication skills with demonstrated ability to influence peers leaders and partners.

• Selfmotivated resilient leader with strong problemsolving capabilities and an innovative improvementdriven mindset.

We offer a multifaceted leadership opportunity in a dynamic international environment working at the forefront of biologics manufacturing science. You will play a key role in shaping MSAT Bio DS capabilities while benefiting from attractive employment conditions strong infrastructure and opportunities for continued professional growth.

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 please contact us via or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Business Planning Developing Others Facility Management Inclusive Leadership Leadership Leading Change Lean Manufacturing Principles Lean Supply Chain Management Manufacturing Compliance Manufacturing Engineering Manufacturing Flow Management Performance Measurement Predictive Maintenance Product Design Report Writing Safety-Oriented Science Technology Engineering and Math (STEM) Application

The anticipated base pay range for this position is :

$150000.00 - $258750.00

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)).
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
Additional information can be found through the link below.
For additional general information on Company benefits please go to: - Experience:

Director