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  • Location: United Kingdom
  • Salary: Competitive hourly rate, Remote working
  • Job Type:Contract

Posted 5 months ago

  • Sector: MedTech, Business Support
  • Contact: Ollie Gearing
  • Contact Email: ollie.gearing@nextphaserecruitment.com
  • Contact Phone: 01403 216216
  • Duration: 6.0 MONTH
  • Start Date: 2021-06-24
  • Job Ref: V-46915 - OG
I am delighted to work with an exciting and successful Pharmaceutical company. That is an award winning specialist company in their field. My client offers the pursuit of technical innovation for world class products, whilst being able to gain new skills and grow your career.

RESPONSIBILITIES



Resolves technical problems effectively and efficiently. Starts with clear and concise Problem Statements and ends with the planned implementation of clearly defined & effective CAPA. Proficient in DMAIC and other six-sigma methodologies.
•       Can coach others on problem solving techniques and methods
•       Works independently to meet stakeholder needs and expectations; may involve the leadership of a matrix team.
•       Maintains oversight on the budget during the change period; manages project risks i.e. leads the development of risk assessment and mitigations with the project team.
•       Leads technical change, from definition of the change, participation in the business case development, through planning, endorsements, execution and closing.
•       Uses their established processes for the proactive optimisation of product – process performance (also know as Process Robustness).
•       Partners with all other functions responsible for progress of the investigation, change or optimisation project, typically Quality, External Supply Operations, Supply Chain, Artwork team, Regulatory, CMO.
•       Good communicator who reports clearly on progress and at a frequency required by stakeholders; can clearly articulate obstacles and challenges encountered, requiring wider team or senior management direct support.
•       Communication is typically through VSOT model (Virtual Site Operations Team).
•       Specific to longer duration projects e.g. process optimisation or technical change: the establishment and management of routine team meetings to facilitate plan updates, decision-making, problem solving, escalations e.g. resourcing gaps, mitigations vs non-adherence to plan.
•       Takes ownership for administrative activities related to the project such as action/issue item tracking and follow up, generation of project meeting agendas and minutes, coordination and facilitation of focused working sessions involving internal and external team members and stakeholders.



SKILLS & COMPETENCIES

•       Excellent written and verbal communication skills. Ability to articulate a problem and communicate effectively with team members and stakeholders at all levels. Intuitive and focused on achieving results.
•       Well-developed interpersonal skills (leadership, communication, integrity, team orientation, flexibility and creativity)
•       Project Management capabilities
•       Highly structured individual who can work with significant complexity and in the “grey space”.
•       Strong knowledge of Pharmaceutical Drug Product manufacturing essential: solid oral dose as well as sterile injectables.
•       Self-driven and works independently to achieve milestones & goals.
•       High level of attention of detail
•       Seeks help with scope when appropriate




EDUCATION AND EXPERIENCE

•       Minimum of a Degree in a Chemistry, Bioscience or Engineering discipline
•       Strong theoretical and practical knowledge of pharmaceutical manufacturing unit processes for both solid dose and sterile injectable dosage forms, with a  minimum of 10 years’ experience working directly within Drug Product process development or manufacturing, ideally in a technical support / troubleshooting type role.
•       Project management training and minimum 3 years experience acting as the leader of matrix teams handling complex technical projects.  Ability to demonstrate successful execution of technical change projects on schedule and to budget.
•       Experience of working in a third party manufacturing environment (either as contract giver or acceptor) is beneficial, but not essential
•       An understanding of the Pharma regulatory environment, while not essential, would be advantageous.
•       Experience of working remotely in a matrixed & virtual environment.