Associate Director, Contract Pharmaceutical Development

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Think What's Possible.Description
Reporting to the Head of Technical Development Operations, this US based individual would manage all OTC Technical Development Pharmaceutical Development work conducted at external facilities in North America, including proof of concept studies GMP activities and the generation of data for regulatory submissions.
Whilst an integral part of the TD team and working closely with a counterpart who will manage outsourced Analytical Development activities, the candidate will work independently of other TD teams. Consequently, the position will be associated with considerable autonomy..

Responsibilities:
Screen contractors and perform technical due diligence on contract development facilities.
Co-ordinate with other functions (eg QA and product supply) to ensure that the due diligence requirements are met.
Define the work to be conducted, milestones, deliverables and timelines.
Act as the primary point of contact between internal project teams and contract development organisations.
Ensure that outsourced projects progress on track and provide regular status reports to the relevant TD and project team members.
Deal directly with any technical issues arising from contract development programs. Ensure that the work conducted at the contractor is of an acceptable technical quality.
Ensure that any GMP products and documentation produced at the contract site meets internal technical standards.
Report progress to TD management team.

Candidate profile:
Pharmacist or Pharmaceutical Scientist with at least 10 years experience working in Pharmaceutical Development, or at least 6 years experience with a PhD
The candidate must be self-motivated and capable of working independently of the TD organisation.
The candidate must have the technical skills required to manage often challenging development programs
The candidate must be a superb communicator, capable of discussing technical issues in detail with scientific staff and of translating these issues for a wide, non-technical audience.
Candidate must be prepared to travel.

Qualifications
Essential:
Degree in Pharmacy / Pharmaceutical Science.
At least 10 years experience in the Pharmaceutical Industry or at least 6 years experience with a PhD.
Significant formulation development / process development experience.
Significant experience managing contract development programs.
Experience working in a GMP environment including GMP manufacturing, clinical trial supply.
Experience of writing regulatory documentation.
Preferred
Experience working in the area of Consumer Health products.
Experience of process transfer and validation.
Experience in the generation of intellectual property.


Novartis is committed to embracing and leveraging diverse backgrounds.
Novartis is an equal opportunity employer M/F/D/V.

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