Are you interested in working at an innovative Medical Device/Pharmaceuticals company?
ROLE SUMMARY:
The individual selected will be a key part of the Sterile Injectables Technical Project Lead Group which aims lead cross function teams 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, and process improvements.
Qualifications
• Masters with minimum of 5+ years or Bachelors with minimum of 7+ years in Engineering (Mechanical, Chemical, or Pharmaceutical preferred) or Life Sciences Experience
• Operations or Tech services experience
• Minimum of three years’ experience in project management/execution role. PMP certified would be advantageous
• Excellent planning skills and knowledge of project management techniques and software.
• Demonstrated ability to influence and manage stakeholders across site and support groups as well as external organizations
• Demonstrated technical leadership to deliver change that impacts results using cross-functional team
• Working knowledge of Lean/Six Sigma tools and approaches to support process robustness and issue resolution
This role will work with network partners and SME’s to develop technical project charter and plans, make sure team member and stakeholder engagement and alignment, plan execution, re-evaluation and adjustment when needed.
ROLE RESPONSIBILITIES:
Technical
• Act as technical project lead to manage and support Sterile Injectable technology projects. Project type include process robustness, component program, Alt API sourcing and tech transfers)
• Work with Subject Matter Experts, site tech service and cross function teams for major technical project or investigation
• Coordinate with site, wet and analytical labs to execute exploratory or feasibility studies on new technologies or continuous improvement efforts
• Ensure compliance with relevant regulations and guidance
Managerial
• Manage technical project through initiation, planning, execution phase
• 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.
• Maintaining monthly project updates in project tracking system and other methods, as requested
• Experience facilitating cross-functional decision-making across center and site functions.
• Experience in decision-making at regional/global levels, impacting multiple stakeholders both internal and external to PGS
Interpersonal Effectiveness
• Highly respected colleague; able to influence leaders across PGS-BTx PharmSci for shared goals
• Strong analytical, strategic and interpersonal skills. Ability to synthesize concepts and requirements and effectively communicate them to all appropriate stakeholders
• Interfacing with and influencing diverse customers including site groups from PGS (Ops, Technical Services, Quality) and network groups such as External Supply, PharmSci, VRU, GCMC
• Attending project meetings, presenting data, and supporting senior management team including travel, when needed
Education
Masters with minimum of 5+ years or Bachelors with minimum of 7 + years in Engineering (Mechanical, Chemical, or Pharmaceutical preferred) or Life Sciences Experience
Location: Remote(Kalamazoo - MI)
Duration: 12 Months
Employment Type: W2 employee with competitive benefits.
Benefits:
· Choice of medical, dental, and vision plans.
· Paid vacation time.
· Competitive hourly rate.
This is a great opportunity, and we are looking to fill this role with the right person. If you are ready to embark on an amazing new career opportunity, APPLY RIGHT NOW!
About Ventura Solutions:
Ventura Solutions is a rapidly growing medical device and pharmaceutical staffing, consulting, and training firm. Our extensive industry expertise in medical device, pharmaceutical, and combination products along with an exceptional talent pipeline make us a top choice for a wide range of projects. We
also offer great benefits which enable us to attract and retain top talent in the medical device, pharmaceutical, and combination products space. For more information and other job opportunities visit us at ventura-solutions.com
Equal Opportunity Employer Minorities/Women/Veterans/Disable