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AS Development Team Leader

Job Title: AS Development Team Leader
Location: Tredegar
Department: Analytical Development
Reporting to: Analytical Development Manager
Responsible for (staff): Analyst(s) & Technician(s)

General Purpose of Role:

  • To organise team activities and carry out routine and where necessary non-routine AS laboratory procedures
    in an effective and efficient manner.
  • To ensure compliance with relevant Company, local and international Regulatory and Client requirements at all
    times.

Main Responsibilities:

  • The job holder has direct people management responsibilities for their team members and ensuring that
    all KPIs, targets and any other deadlines are met individually and by the team.
  • Responsible for the leadership of team of designated personnel within the Analytical Development group
    ensuring delivery of method development and validation activities, written and oral communication of
    technical aspects of analytical analysis to internal and external customers in accordance with agreed
    service levels.
  • To manage and process all HR and departmental documentation for the team members including;
    attendance sheets, overtime forms, sickness related documents, absence request forms and annual
    leave and staff appraisals including 1:1s, probationary reviews and PMRs.
  • To professionally and consistently conduct all relevant Team Leaders’ activities, including managing and
    recording as required, performance, absence, timekeeping, holidays, grievance, discipline, training and
    development, etc.
  • To ensure the training and development of the Team is fully delivered, understood and evidenced in line
    with both day to day and Company requirements.
  • To organise team activities to perform routine laboratory procedures and to oversee laboratory work
    within the team.
  • To authorise technical documentation and to routinely participate in batch release procedures in relation
    to the team’s activities. This may extend to other areas within the department, as required.
  • To prepare technical documentation within the department, as required.
  • To appraise staff within the team, including setting and assessing achievement of objectives.
  • To train others as required, to ensure that all members of the Team are adequately trained, and to ensure
    that appropriate training records are maintained for the team.
  • To maintain sectional expenditure within budgetary constraints.
  • To maintain a thorough understanding of international regulatory and ISO requirements pertinent to the
    team and to ensure that all work within the team complies with these, with departmental procedures and
    the principles of Good Manufacturing Practice.
  • To ensure that all sectional lead times, including those of sub-contract facilities providing a service to the
    team and team investigations, deviations and change controls are complied with, subject to there being
    no attenuating circumstances.
  • To carry out and manage projects within the department and at international level, as required.
  • To develop and validate laboratory procedures within the team and with other organisations, as required.
  • To review analytical and laboratory data within the department for accuracy, completeness and
    compliance with documented procedures.
  • To ensure that all health and safety procedures within the team are adhered to with respect to personal
    duties and the duties of others.
  • To communicate effectively with other groups on site, and to participate with them in problem solving
    activities as required.
  • To carry out any other tasks which may be required from time to time.
  • Identify self-development needs for future performance and development needs for team members/direct
    reports.
  • To undertake such tasks and to manage specific internal or ad hoc projects as and when required to meet
    department and business needs and within the scope of the job-holder’s capabilities and responsibilities.

Regulatory/Industry Responsibilities:

General

  • The job holder is responsible for adhering to PCI SOPs, Health & Safety, GMP and other regulatory
    guidelines.

GMP Requirements Hierarchy

  • GMP Skill Level 1 is essential for this role (further information regarding GMP Requirements Hierarchy, can be obtained at SOP-L&D-001)

Specific Qualifications:

  • Degree educated in a scientific subject (preferably Chemistry or Microbiology)

Previous Work Experience:

  • Excellent written and verbal communication skills.
  • Similar level supervisory experience within a laboratory environment essential, ideally in a pharmaceutical company.
  • Dealing with external customer / clients

Specific Knowledge / Skills Competence:

  • cGMP
  • Good computer skills across all Microsoft Packages

Behavioural Competencies:

  • Accountability
  • Teamwork
  • Enterprise
  • Customer Focussed
  • Able to handle competing priorities

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