Senior Scientist - MSAT External Site Lead - 2406198252W

Description

Johnson & Johnson is hiring for a Senior Scientist - MSAT External Site Lead! This position will be located (onsite/hybrid) in Durham, North Carolina as a PIP (Person-in-Plant).

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 pharmaceutical products? Apply now for this exciting chance to join our team!

Within the Manufacturing Sciences and Technology (MSAT) Large Molecule Drug Substance team, the External Site Lead (ESL) is the J&J single point of contact (POC) and is responsible for MSAT activities at the assigned External Site (or CMO). They will collaborate with key MSAT functions such as Global Technical Owners (GTOs), Technical Launch integrators (TLIs), and Innovation & Technology Deployment (ITD). They also are a core team member of the Virtual Management Team (VMT), in conjunction with Partnership and External supply (PES), External Quality (EQ), Procurement, and Global Planning. The ESL partners with team members within MSAT, VMT, and others (R&D, VCM, Engineering, etc.) to meet technical needs of New Product Introductions (NPIs) and commercial products Life Cycle Management (LCM). The ESL plays a relevant role within the J&J External Site model to establish the connections and partnership between internal (J&J) manufacturing sciences functions and the External Site.

Key Responsibilities:

• Serve as primary J&J contact for MSAT activities at the assigned External Site and represent MSAT at VMT and QBRs (Quarterly Business Reviews)

• Be knowledgeable about the technical and scientific aspects of the Drug Substance (DS) products and its translation into the LCM and product strategy needs

• Supervise technical process and product performance of products manufactured at the external manufacturing sites

• Provide technical recommendations into quality deviations related to the manufacturing process and support product impact assessment, root cause investigations, and potential corrective and preventive actions (CAPAs); may lead site specific investigations and supports global (multi-site) investigations

• Lead the assessment and implementation of manufacturing process changes, including Technology deployment

• Support technology transfers activities led by TLI, from Process Fit to Plant (PF2P) to PPQ execution, reporting, and fling submission

• Lead LCM site specific activities for commercial products at the site (e.g., CPV reports, resin lifetime reports, Annual Product Reports, Health Authorities questions, audits, etc.)

• Maintain an understanding of each product strategy and needs, and work closely with TLIs/GTOs in updating product strategy and deployment changes at the external site

• Serve as technical lead for identifying new technology or areas of improvements on current and future processes, capital utilization, cost of goods (COGs) optimization, and provide expertise on feasibility and risks management at the assigned External Site

• Participate in technical, quality, and compliance risk assessment and development of mitigation strategies, as well as possible BCP options

• Support Best Process at Launch (BPAL) assessment by providing guidance from the External Site processes

Qualifications

Education:

• Minimum of a Bachelor's/University or equivalent degree required; Master's degree or focused degree in Engineering, Chemistry, Pharmaceutics, Biological Sciences, or other relevant study is preferred

Experience and Skills:

Required:

• Minimum 6 years of relevant work experience

• Experience in biopharmaceutical development or manufacturing

• Experience in one or more of the following areas: Process Development, NPI, Technology Transfer, Process Improvements, Process Validation, and/or ongoing Production Support

• Ability to champion team efficiency and cohesiveness and to work collaboratively to complete, deliver, and get results through the various matrix teams

• Ability to influence and lead peers, superiors, and external partners, including interaction with senior management

• Ability to lead complexity, uncertainty and change, effectively handling and resolving conflicting priorities

• Motivated, self-starter with the ability to work independently and possessing a good sense of prioritization of assigned tasks/goals and handle time accordingly

Preferred:

• Demonstrated and detailed technical knowledge of manufacturing site unit operations

• Partnership experience with external companies and/or suppliers

• Proven experience as a Product or Project Lead in LCM and/or NPI (e.g., projects, investigations, and innovation/optimization opportunities)

• Demonstrated leadership in providing integration of activities/information across multifunctional groups and sites

• Document management systems such as ERIS, TruVault, SAP, and/or TrackWise

• Experience with tools and software for data collection analysis (e.g., Minitab, PI, SIMCA)

Other:

• Requires up to 10% domestic and international travel

• 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

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 .

Primary Location NA-US-North Carolina-Durham

Organization JANSSEN SUPPLY GROUP, LLC (6046)

Relocation Eligible: Yes - Globally

Travel Yes, 10 % of the Time

Job Function Process Engineering

Req ID: 2406198252W