Technical Director

PURPOSE & SCOPE OF THE POSITION

The Technical Director will provide scientific and technical leadership across the company for pre-clinical, clinical, and licensed human medicinal products manufactured for clients. As a GMP sterile pharmaceutical manufacturing company, this role is fundamentally important in directly supporting the manufacturing capability and ensuring the company retains technical credibility. Alongside the Head of Manufacturing and Quality teams, this role will ensure that the company is meeting its core requirement to offer technical excellence and GMP compliance of internal operations while supporting business development activities and face-to-face engagement with clients and external stakeholders.

The Technical Director will report directly to the Chief Operating Officer (COO) and will be responsible for developing the technical function. The incumbent candidate will promote the collective technical capability of the business by attending external events and delivering technical presentations and lead the technical assessments of new and existing projects.

BEHAVIOURS

  • Collaboration
  • Responsibility
  • Trust and respect
  • Communicating effectively
  • Leadership
  • Excellence

 

person specification

Experience

  • A post graduate degree in Life Sciences with extensive experience in pharmaceutical sciences, biology, virology biotechnology or relevant field.
  • Extensive technical and leadership experience from multiple roles in the pharmaceutical/biopharma industry and having applied knowledge in practice including scale-up/development and/or technology transfer experience with emphasis on biological drug manufacture / development biologics and/or ATMPs and single use processes including more than one of the following areas:
  • Injectable sterile pharmaceutical formulation experience
  • Lyophilisation technical knowledge and experience
  • Small molecule and Isolation technology experience (e.g., Cytotoxic API’s)
  • Knowledge of process improvement techniques
  • Experience developing new processes / initiation of new GMP activities
  • Technical appreciation of analytics / testing
  • Strong current working knowledge of GMP and its implementation
  • Strong knowledge of GMP validation and qualification requirements for equipment and products including master validation plans and preparation of /review of CMC sections for INDs, IMPDs commercial licences
  • Line management experience of diverse technical teams
  • Participation on a large capital project team
  • Experience of GMP quality systems and standards
  • Knowledge of Health and Safety compliance
  • Experience with UK Innovate projects
  • Experience with clinical labelling and packaging of drug product

KEY COMPETENCIES

  • Demonstrate excellent GMP knowledge and understanding of aseptic manufacturing and other related support processes in practice
  • Critical thinking and problem-solving skills including uses of gap analysis and risk assessment tools
  • Effective planning and organisation
  • Demonstrates flexibility in a fast-moving environment
  • Adaptability in a fast-paced growth-oriented organisation
  • Good Communication Skills; verbal and written
  • Ability to develop and present clear and compelling quality and business cases
  • Attention to detail
  • Mediation, influencing and leading
  • Ability to engage and align other stakeholders outside the project team
  • Strong team work ethic
  • Experience participating in and developing efficient teams
  • Proactively responds to challenges and shows initiative
  • Proactively drives forward process improvements
  • Continuous improvement approach to operations to ensure cost effectiveness
  • Experienced trainer to proactively upskill competency level in dept
  • Ability to quickly implement changes to activities to meet client needs
  • Record of achieving objectives to agreed timescales
  • Sound decision making
  • Diligent and motivated to complete a job to best of ability
  • Experience of managing a budget and achieving commercial deliverables
  • Dynamic approach to interface with internal departments and external clients

 

TO APPLY

If you would like to apply for this role, please send your CV and cover letter to lorraine.den-kaat@symbiosis-pharma.com

KEY ACCOUNTABILITIES

Responsibilities will include providing leadership of business technical operations and the development and subsequent implementation of a long-term programme of technical development aligned with the manufacturing, quality, and overall business strategy, and the delivery of the annual business plan in the following main areas: –

Client Services

  • New client manufacturing project assessment and project on boarding
  • Provisions of technical support to Manufacturing and Supply Chain departments for the manufacture of client products and procurement of correct raw materials for manufacturing
  • Development and provision of product and process development services for clients’ projects from pre-clinical to commercial supply
  • Develop business technical plans for the addition of future service extensions

Manufacturing and Technical Capability

  • Maintain (and translate internally where applicable) visibility of emerging technical trends and technologies which are relevant to Symbiosis and its clients
  • Contribute to the continued improvement and development of the core operational processes across and between departments within the company
  • Identifying gaps in process capability
  • Identifying and supporting introduction of new technology for manufacturing activities
  • Participating in facility design and development

Quality

  • Ensure compliance with the principles of Good Pharmaceutical Manufacturing Practice (GMP) and industry standard practices
  • Critically evaluate quality and manufacturing systems to ensure best practice
  • Participate in internal and external GMP audits as required
  • Maintain control documentation and relevant standard operating procedures in liaison with Quality Dept
  • Ensure, with Quality Dept, that the resolution of quality exceptions is undertaken and completed in a timely manner
  • Ensure, with QA, that GMP competency-based training for all staff is developed and maintained

Business Functions

  • Lead the Technical Team and develop and /or recruit additional talent to deliver client services
  • Participate as part of the Management Team in delivery of the company’s annual business plan
  • Propose and subsequently manage a departmental budget
  • Contribute to the generation of the company annual budget
  • Ensure all relevant legislation e.g., Health and Safety at Work, COSHH etc is adhered to within manufacturing dept
  • Promote the work ethic, culture, and values of the wider company

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