Job Description

　　The scope of the current open position includes (a) Drug Product technical investigations, solution development & implementation; (b) technical change management and (c) proactive process optimization projects resulting in improved product & process performance.

　　The sites where the products are manufactured are non-client sites i.e. a 3rd party manufacturing location (CMO).

　　The Tech Services Specialist or Engineer uses their own expertise as well as leveraging subject matter experts from across the company to develop and deliver effective solutions vs identified challenges; interacts closely with Operations, Quality, Supply Chain functions, as well as Regulatory Affairs and the CMOs themselves.

　　POSITION 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 already established processes for the proactive optimization of product process performance (also known as Process Robustness).

　　 Partners with all other functions responsible for progress of the investigation, change or optimization 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 company VSOT model (Virtual Site Operations Team).

　　 Specific to longer duration projects e.g. process optimization 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 and Requirements

　　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. null

　　We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].