Career

Technical Director

Scotland
Full Time
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

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

Apply for this position

Please submit your details, CV and a covering message to apply for this role.

Drag & drop file here or click the button below Upload a file