Sterile Injectable Technology Subject Matter Expert in Peapack, NJ at Integrated Resources, Inc

Date Posted: 4/11/2021

Job Snapshot

Job Description

Job Description: Process Engineer

ROLE SUMMARY

The individual selected will be a key part of the Sterile Injectables Manufacturing Science and Technology Group which aims to deliver on process robustness and customer satisfaction through innovative solutions to manufacturing issues. In Product is full product life cycle support for aseptic drug products, including co-development, technical transfer, scale-up, process validation, registrations, ongoing troubleshooting and process improvements.

This position specifically involves the management of technical and development activities for product transfers to and from the *** network and contract manufacturing organizations (CMOs), development / improvement of manufacturing processes for new and existing sterile injectables products across all business units, and manufacturing site support for critical investigations.
This position requires effective and direct communication skills, Product leadership and facilitation, and the ability to influence and integrate various colleagues from all levels of the organization.

ROLE RESPONSIBILITIES
As a MSAT Subject Matter Expert your responsibilities could include:
Technical
Providing technical subject matter expertise and issue resolution for major/moderately complex investigations for aseptic sterile injectables, biologics and vaccines and assisting in completing all required documentation in a timely manner
Participating in the Co-Development process, particularly in Late Stage Development/Phase 3 Clinical Supply to commercialization and continued product support
Applies technical knowledge and skills to achieve goals of the department
Preparing, reviewing, and may approve documents including protocols, reports, technical assessments, memos, study plans, and meeting minutes, as needed
Collaborating with wet and analytical labs (e.g., Experimental Pilot Plant in Puurs) to execute exploratory or feasibility studies

Managerial
Contributing to and occasionally managing moderately complex projects
Maintaining project updates in IMEX VMB and other methods, as requested
Good influencing skills and ability to work in a matrix organization to deliver results
Comfortable with multifunctional and multi-cultural environments. Effective influencer, motivator and communicator

Interpersonal Effectiveness
Highly respected colleague; able to influence team members across different organizations
Strong analytical, strategic and interpersonal skills. Ability to synthesize concepts and requirements and effectively communicate them to all PGS stakeholders
Interfacing with and influencing diverse customers including site groups from PGS (Ops, Technical Services, Quality) and network groups such as External Supply, QA, PharmSci, Procurement, and GCMC

Approach / Mindset
Recognizes cross-functional impact in all decision-making; proactively reaches out to external stakeholder groups to Product alignment on cross-functional issues
Able to identify root causes and drive to problem resolution; orientation towards action - anticipates problems and acts proactively to resolve; demonstrated initiative, drive, and creativity in problem solving
Knows when to report or escalate risks and issues to leadership
Use of DMAIC principals to drive resolution of issues and drive improvement of supplier performance
Embraces *** Purpose: Breakthroughs that change patients lives through the incorporation of the Product Moves and Values and Behaviors

QUALIFICATIONS

Masters with minimum of 2+ years or Bachelors with minimum of 3+ years in Engineering (Mechanical, Chemical, or Pharmaceutical preferred) or Life Sciences Experience
Sterile injectables/vaccines formulations and strong background in filling operations of Drug Product
Operations or Tech services experience
Experience in particle science/suspensions is an advantage
Experience with lyophilization is an advantage
Black Belt or Green Belt experience is an advantage
Ability to execute laboratory studies with nominal guidance and experience with aseptic techniques including working in biosafety cabinets, handling sterile liquid transfers, and sterile manipulation of drug substances for use in small- and intermediate-scale formulations
Knowledge of cGMP requirements and compliance
Excellent communication and technical writing skills
Working knowledge of Minitab or JMP preferred
Ability to manage own time to meet agreed targets and develops plans for short-term and long-term activities
Ability to think creatively and find innovative solutions is a plus

Notes:
-6+ years exp., independent worker. Pharma exp., Product process exp.,
-PM experience. initiate projects- full cycle- to close (2+ years)
-Drug product process experience, formulation, filling
- Data analysis, excel, MS suites, comfortable with technical writing
- BS min, education in Engineering is highly preferred or other sciences would be okay
- tech transfer exp.
- CMO exp.
Position Comments visible to MSP and Supplier: remote but onsite support could be needed if sites open. EST location preferred. If local to Rocky Mt, PPK, NJ or Kalamazoo would be ideal IF onsite support were to be needed.