Current jobs related to Msat Sm Dp External Scientist - Titusville - Johnson & Johnson

Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an MSAT Small Molecule Drug Product (SM DP) External Scientist

MSAT (Manufacturing Science and Technology) is a division of the Innovative Medicine Supply Chain (IMSC) of Johnson & Johnson. MSAT is a worldwide organization with members located across the geography in close vicinity to the Internal Manufacturing Network (MTO) and External Manufacturers, providing Technical Competence and Manufacturing Excellence to Johnson and Johnson’s pharmaceutical environment and product portfolio.

The MSAT SM DP External Scientist is responsible for providing technical oversight to external manufacturing (EM) sites. They will also be responsible for site ownership in performing due diligence, auditing, and site onboarding. The Scientist will conduct technical/risk assessment, execution, and/or oversight of New Product Introduction (NPI), technical transfers, and Product Life Cycle (LCM) management. They will be involved with standards and new technology deployment, Multi-Variate Analysis (MVA) & statistical analysis, Proactive assessments and de-risking of products and process through collaboration with various other MSAT teams, different functions, and partners.

**Key Responsibilities**:

- Handle execution of drug product technology transfer, product life cycle activities, material qualification, and cleaning validation
- Support NPI using applicable tools and standards in collaboration with Virtual Management Team (VMT), key supply chain functions, Technical launch integrators / owners, and EM site
- Act as Technical coordinator for CMO process technology proficiency assessment, technology standards, and implementation of MSAT Technology Roadmaps
- Serve as primary contact and site owner for technical issues related to EM and represent in VMT by being a single technical voice including EM, thus supporting decision / actions
- Maintain and develop good understanding of the status regarding ongoing and future planned technical activities at site
- Engage in Site Lifecycle processes (due diligence / selection, onboarding, engage, ongoing monitoring, disengage) including support to localization; also be involved in technical assessment / due diligence of product portfolio / in
- licensing
- Support working models and tools in handling EM from technical perspective which includes Technical risk metrics & Switching Effort / Complexity metric for fit-for-purpose segmentation model, and account planning/adherence
- Conduct technical assessment of change controls and other quality related activities by associating with Quality for audits and inspections
- Provide technical support on site for investigations and resolution of deviation / OOS (process, cleaning, troubleshooting) by collaborating with engineering, product launch, and technical owners

**Qualifications**:
**Education**:
**Experience and Skills**:
**Required**:

- Minimum 6 years of relevant work experience
- Demonstrated experience/expertise with various dosage forms, including experience with solids manufacturing technology, process, and transfer
- Experience working with external manufacturing network (CMO)
- Basic knowledge of Small Molecule Supply chain (products, customers, suppliers, plants)
- Strong communication and collaboration/networking skills with the ability to interact at different levels of the organization/sector
- Ability to lead activities under general direction, and demonstrate a good sense of prioritization of assigned tasks & goals and handle time accordingly
- Strong understanding and knowledge of Q&C (Quality & Compliance) and the regulatory requirements (e.g., GMP, EHSS, etc.) related to pharmaceutical manufacturing environment

**Preferred**:

- Experience in new pharmaceutical manufacturing technology especially OROS technology, continuous manufacturing, or related technology

**Other**:

- May require up to 25% travel, domestic and/or international depending on business 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 and depending on business needs

**_Why join Johnson & Johnson _**
- The anticipated base pay range for this position is $90,000 to $144,900 in New Jersey or $75,000 to $120,750 in Puerto Rico. _
- 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 employ