Senior Principal Scientist - MSAT Material Sciences (1 of 2)

at  Johnson Johnson

Johnson & Johnson is hiring for a Senior Principal Scientist - MSAT Material Sciences (1 of 2)! This position will be located in Malvern, Pennsylvania; alternate work locations may be considered in Titusville, New Jersey or Horsham, Pennsylvania. Remote work options may be considered on a case-by-case basis and if approved by the Company.
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 https://www.jnj.com/.
Are you interested in joining a team that is positively impacting patients’ lives by ensuring efficient and effective manufacturing of our biopharmaceutical products? Apply now for this exciting chance to build and lead our MSAT Material Sciences team!
Within the J&J Innovative Medicine Manufacturing Sciences and Technology (MSAT) Large Molecule Drug Substance team, the MSAT Material Senior Principal Scientist will be responsible for management and optimization of raw materials and process contact materials to improve product quality, value and ensure regulatory compliance. They will partner with the MSAT Material Sciences Lead in building and institutionalizing the processes and tools to deliver raw material control strategies used in commercial supply chain.

Key Responsibilities:

• Owner of Lifecycle Management (LCM) raw material control strategy including supplier/material reliability, specification management, and critical material attribute monitoring
• Partner with MSAT drug substance and drug product operational teams for raw material-related manufacturing investigations and risk assessments
• Lead multidisciplinary product sub-team teams for raw material readiness in support of new product introduction, technical transfer, and commercial manufacturing operations
• Interpret and implement industry and regulatory guidance for raw materials, ensuring compliance with GMP, quality, and scientific principles
• Author, review, and approve raw material sections of regulatory documents for global filing updates of Janssen biotherapeutics drugs
• Leverage networking and influencing skills to ensure good collaboration with partners in MSAT, Therapeutic Development & Supply (TDS), Value Chain Management (VCM), Quality, and Regulatory

QUALIFICATIONS

Education:

• Minimum of a Bachelor’s or equivalent University degree required; Master’s or focused degree preferred in Chemistry, Biology, Materials Science, Engineering, Pharmacy/Pharmaceutics, or related field

Experience and Skills:

Required:

• Minimum 8 years of relevant work experience
• Experience within Biologics or Pharmaceutical manufacturing and/or development (CMC) environment
• Experience and strong knowledge of technology transfers
• Experience leading or managing projects or process improvements
• Excellent written and oral communication skills and ability to influence peers, superiors, and partners, while collaborating within a cross-functional team
• Excellent interpersonal skills with the ability to adapt effectively to manage a growing portfolio
• Motivated, self-starter able to work independently with demonstrated problem solving skills

Preferred:

• Proficient knowledge of raw materials including cell culture media, chemicals, polymeric contact materials, and excipients in biotherapeutic products
• Competency and experience in quality investigations, conducting risk assessments, change control, and regulatory submissions
• Experience, training, or certification in Lean, Six Sigma, or Process Excellence tools & methodologies

Other:

• May require up to 10% domestic and international travel, depending on business needs and work location

The anticipated base pay range for this position is $118,000 to $203,550.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be 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.

Employees are eligible for the following time off benefits:

• Vacation – up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year
• Work, Personal, and Family Time - up to 40 hours per calendar year

Additional information can be found through the link below. For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits.
This job posting is anticipated to close on September 6, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com

• Owner of Lifecycle Management (LCM) raw material control strategy including supplier/material reliability, specification management, and critical material attribute monitoring
• Partner with MSAT drug substance and drug product operational teams for raw material-related manufacturing investigations and risk assessments
• Lead multidisciplinary product sub-team teams for raw material readiness in support of new product introduction, technical transfer, and commercial manufacturing operations
• Interpret and implement industry and regulatory guidance for raw materials, ensuring compliance with GMP, quality, and scientific principles
• Author, review, and approve raw material sections of regulatory documents for global filing updates of Janssen biotherapeutics drugs
• Leverage networking and influencing skills to ensure good collaboration with partners in MSAT, Therapeutic Development & Supply (TDS), Value Chain Management (VCM), Quality, and Regulator