Will you be our new ambassador?
Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team.
Let's look together at your first challenge with us!
MSAT Subject Matter Expert
In this role you 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 scope is full product life cycle support for aseptic drug products, including co-development, technical transfer, scale-up, process validation, registrations, ongoing trouble shooting and process improvements. The consultant will demonstrate a proven operational expertise in formulation, preparation, lyophilization or aseptic filling processes in at least 1 manufacturing site. This project requires behaviors exhibited through effective and direct communication skills, bold leadership and facilitation, and an effortless ability to influence and integrate various colleagues from all levels of the organization.
Scope of work:
- Providing advanced technical subject matter expertise and issue resolution for major/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 at the business unit level
- Preparing, reviewing, and approving documents including protocols, reports, technical assessments, memos, study plans, and meeting minutes, as needed
- Collaborating with wet and analytical labs to execute exploratory or feasibility studies.
- Contributing to and occasionally leading complex projects
- Maintaining monthly project updates in project tracking system and other methods, as requested
- Strong influencing skills and ability to work in a matrix organization to deliver results
- Comfortable with multifunctional and multi-cultural environments.
- Highly respected colleague; able to influence team members across PGS and other business units
- Strong analytical, strategic and interpersonal skills. Ability to synthesize concepts and requirements and effectively communicate them to all stakeholders
- Interfacing with and influencing diverse customers including site groups from PGS (Ops, Technical Services, Quality) and network groups such as External Supply, PD&S, PharmSci, VRU, GCMC
- Attending project meetings, presenting data, and supporting senior management team including travel, when needed
Approach / Mindset
- Recognizes cross-functional impact in all decision-making; decisions may impact business unit goals. Proactively reaches out to external stakeholder groups to gain 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 and provides alternative approaches/solutions to mitigate these risks/issues
- Use of DMAIC principals to drive resolution of issues and drive improvement of supplier performance
Who are you?
- Master’s with minimum of 7+ years or Bachelor’s with minimum of 10+ years in Engineering (Mechanical, Chemical, or Pharmaceutical preferred) or Life Sciences Experience
- A strong operational or engineering background in Drug Product operations is a requirement
- Knowledge of cGMP requirements and compliance
- Excellent communication and technical writing skills
- 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
- Ability to participate in production floor activities when needed
- Ability to travel globally 15-25% of working time
- Adaptation of work schedule to accommodate meetings with colleagues in different time zones
What can Jefferson Wells do for you?
As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.