MSAT Technical Launch Integrator, Principal Engineer

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. Learn more at jnj.com

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:

Athens, Georgia, 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 https://www.jnj.com/innovative-medicine.

We are searching for the best talent for an MSAT Technical Launch Integrator (TLI), Principal Engineer! This hybrid position will be located in Athens, Georgia (USA) or Titusville, New Jersey (USA).

Within Manufacturing Science and Technology (MSAT) of Johnson & Johnson Innovative Medicines Supply Chain (IMSC), the TLI will be responsible for ensuring fit for plant and commercial readiness during technical development and execution of the transfer of pharmaceutical processes and products into the supply chain and the global marketplace. A main objective of the role is strong collaboration with R&D and the commercial manufacturing sites to ensure a robust product and manufacturing process is developed and successful transferred considering Best Process at Launch (BPAL) principles.

The TLI is a member of the Value Chain Team (VCT) and Site operational teams, and will lead the new product introduction (NPI) team at the sites. They will also be a full member of several R&D teams, CMC Sub teams, and R&D SI (Scientific Integrator) Sub teams, working hand-in-hand with R&D to successfully develop and transfer to the commercial launch site (internal or external). The focus of this TLI position is on API and SDP (Spray Drying) within the Synthetic Platform.

KEY RESPONSIBILITIES:

• Lead end-to-end MSAT technical transfer activities including process fit for plant, serving as the primary point of contact for Supply Chain and ensuring manufacturing site readiness from transfer through commercial launch.

• Ensure incorporation of Supply Chain technical expertise to include BPAL and Quality-by-Design (QbD) principles by providing input from early development through late development, encouraging alignment between Supply Chain and R&D.

• Contribute to, review, and approve regulatory documents for global markets and fully support the MSAT Technical Review Process and serve as the Supply Chain technical product authority.

• Represent the manufacturing sites on the CMC R&D Sub-team and the VCT.

• Build value by proposing potential product supply strategies ensuring security of supply, low COGS, tax advantages, while balancing commercial robustness, innovation, EHS, QA, compliance, and financial requirements.

• Develop the manufacturing site execution plan per product, in line with the overall strategy as outlined by the R&D, CMC, and Value Chain teams.

• Ensure alignment and endorsement of this strategy within the manufacturing sites and TLI function of Supply Chain MSAT.

• Coordinate product introduction at the site from transfer through launch covering raw materials, process, EHS, engineering, packaging, sterilization (if required), and other items needed for a successful technical transfer and launch.

• Deliver clinical through to commercial API/SDP supply from the manufacturing site, ensuring manufacturing performance, cost, and process robustness requirements are met.

• Influence at all organizational levels ensuring project targets are achieved and excellent leadership and negotiation skills with the ability to operate successfully in a multidimensional work environment and collaborate with multi-functional teams.

• Own the estimation Supply Chain resource requirements for assigned projects, and ensure proactive technical status communications to leadership.

QUALIFICATIONS:

EDUCATION:

• Minimum of a Bachelor’s/University or equivalent degree is required; advanced degree and/or focused degree in a Scientific or Engineering field such as Chemistry, Pharmaceutics, or Chemical Engineering is preferred

• Project management certification (e.g., FPX, PMP, or equivalent) is preferred

EXPERIENCE AND SKILLS:

Required:

• Minimum of 6 years of relevant work experience

• Experience in the development or manufacturing arena, focusing on API

• Broad, demonstrated technical background in API Chemical manufacturing, preferably including understanding of process & product development, quality, cGMP, and regulatory knowledge related to Small Molecules

• Strong communication skills and the ability to effectively communicate across all levels (shop floor to leadership) to lead and influence without direct line authority

• Proven ability to lead moderate to large complex projects and teams, programs, or initiatives, both internally and externally

• Strong risk assessment/management skills, and ability to balance considerations toward business, scientific, quality, EHS, and compliance needs

• Knowledge of plant functionality, plant capacity, and COG calculations

• Strong decision-making and problem-solving skills to seek solutions to complicated problems (independently or through others) and to develop recommendations or design solutions

• Experience handling investigations and statistical assessments to support Continued Process Verification and ensure robust processes

Preferred:

• Experience with Drug Products (DP), mainly in Spray Drying

• Knowledge of contract manufacturing activities and shaping working relationships with global external partners

• Experience and interest in collaborating across global teams and partners, with various cultures, nationalities, and/or perspectives

• Strong skills in business negotiation, sourcing strategies, and understanding of financial impact

• Knowledgeable with chemical synthesis, peptide, oligonucleotide, and/or conjugate

OTHER:

• Ability to work in a global work environment, across different time zones

• May require up to 50% domestic and international travel, depending on project needs

• Requires the ability, through our flexible work policy, to work on-site a minimum of three days each week, with the option for two remote workdays each week

#LI-Hybrid

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.

Required Skills:

Preferred Skills:

Agile Decision Making, Business Savvy, Coaching, Corrective and Preventive Action (CAPA), Crisis Management, Critical Thinking, Disruptive Innovations, Emerging Technologies, Industrial Hygiene, Lean Supply Chain Management, Organizing, Process Control, Process Engineering, Product Costing, Program Management, Project Schedule, Science, Technology, Engineering, and Math (STEM) Application, Technical Research

The anticipated base pay range for this position is :

$102,000.00 - $177,100.00

Additional Description for Pay Transparency:

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)).
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
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
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits