close

Manager Production (DSP & Solution Preparation)

link

Offered by:

Incyte

Research / Academic
Yverdon-les-Bains

Manager Production (DSP & Solution Preparation)SUMMARYLeads and manages all manufacturing operations related to DSP and Solution preparation activities within Drug Substance Manufacturing under cGMP regulations in a multi-product facility for clinical and commercial supply. Provides leadership, direction and oversight to the associated teams.Responsible to meet production and quality performance goals.In addition, this position is accountable to manage new Process/Product Implementation. Also responsible for supporting regulatory inspections and audits as necessary.DUTIES AND RESPONSABILITIES

  • Agree Incyte’s vision and establish driver for DSP and Solution Preparation members
  • Line manage a group of Associate Managers/Team Lead and theirs respective teams
  • Manage, plan, lead and execute batch related activities – including batch release
  • Own training matrix and prepare and deliver training to new members of the team
  • Identify operational gaps and solve them in order to reduce non-valued activities
  • Author, review, approve, maintain life cycle (…etc.) of all required Standard Operating Procedures, Work Instructions, Manufacturing Batch Records, PQ protocols and other quality documents related to areas of responsibility, as well as support other areas as required
  • Own training matrix and prepare and deliver training to new members of the team
  • Act as a mentor to more junior team members and lead by example to ensure timely batch execution and release, and proactively propose problem resolution
  • Provide support during Health Authorities inspection
  • Raise, investigate and close events, deviations and non-conformances
  • Support the tracking of manufacturing performance metrics
  • Contribute positively to a strong culture of business integrity and ethics
  • Act within compliance and legal requirements as well as within company guidelines
  • Lead new process technologies implementation
  • Delegate to: Sr Manager / Director Manufacturing

REQUIREMENTS

  • Biotechnology or pharmaceutical BSc (e.g. Swiss HES) degree preferred or relevant experience from chemical, food, pharmaceutical or biotech industry
  • Must have hands-on experience of equipment commissioning and qualification
  • Demonstrated, solid hands on experience of USP/DSP manufacturing – typically 7-10 years
  • Ability to work in a fast paced – high regulated environment
  • French and English
  • Team work oriented mindset
  • Contribute positively to a strong culture of business integrity and ethics
  • Act within compliance and legal requirements as well as within company guidelines