Drug Product Project Leader

Vor 5 Tagen

Basel, Schweiz Novartis Vollzeit

389788BR

**Drug Product Project Leader (Oligonucleotides) (M/F/d)**:
Switzerland

**About the role**

Location: Basel, Switzerland
Join us in a cutting-edge role as a Drug Product Project Leader (DPPL) for Oligonucleotides, where you will have the opportunity to work on innovative parenteral formulations and contribute to the development of patient-centric drugs. This role is perfect for someone who is passionate about bringing transformational medicines to the market and working on exciting novel pharmaceutical products.
Purpose
- Leads and runs all Drug Product (DP) project activities linked to the development of parenteral dosage forms.
- Supports & coaches team members, participates in scientific teams and contributes to the overall Technical Research and Development (TRD) strategies and goals.
- Designs, plans, performs, interprets and reports the results of scientific experiments for the preparation and timely delivery of drug product including GMP Manufacturing.

Major Accountabilities
- Leads and manages all formulation and process development activities for assigned projects team in line with Novartis values and behaviors. Motivates, coaches and enables team members for high performance in technical skill set as well as values & behaviors.
- Develops sound DP project strategy including contingency planning and risk assessments involving functional experts and in line with the overall TRD project plan, development guidelines (as applicable), SOPs and TRD/PHAD strategy.
- Monitors project plans and ensures timely availability of agreed deliverables. Proactively communicates overall project strategy, key issues and any other critical topics in a timely manner to the appropriate management level, to the TRD project leader, other relevant project team member(s) and within the line function and with 3rd parties.
- Ensures adherence to the EP/ LP project review process through relevant governance boards. Ensure high quality documentation is provided per guidelines to facilitate these reviews.
- For Late Phase DPPL: Leads the Transfer Team as per R&R defined in SOP; Leads Life cycle management (LCM) DP and clinical development activities in alignment with TDP.
- Ensures availability of pre-requisites for transfer of projects to other sites as applicable (e.g. transfer documentation, licenses, equipment, resource plan).
- Assesses, consolidates and negotiates resource needs (internal & external costs) and timelines for assigned projects within the DP project team and ensure resources are accurately reflected in TRD planning systems (e.g. Horizon). Lead budgeting process for DP activities. Acts as author, reviewer or approver role for PHAD owned documents according to existing SOPs and guidelines. Supports the writing of submission modules, supports internal and health authority inspection requirements and answering of HA-questions.

**Commitment to Diversity & Inclusion**:

- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Role Requirements**

Key requirements
- Ph.D. in Chemistry or related disciplines with 5+ years of biopharmaceutical experience in Oligonucleotide (mRNA, siRNA, ASO) or Biologic field (ADC, proteins) OR Master degree with 7+ years pharmaceutical experience, with demonstrated formulation development (parenteral, aseptic, solution and/or suspension) and manufacturing process or related expertise.
- Experience with aseptic Drug Product manufacturing of oligonucleotides including process transfer and QbD design.
- Experience with devices (pre-filling syringes, vial, combination product)
- Experience with in-use compatibility study and Instruction for use preparation.
- Experience with process development and regulatory issues parenteral Drug Product clinical-grade manufacturing a plus.

Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Accessibility and accommodation

**Division**

Development

**Business Unit**

TECHNICAL R & D GDD

**Work Location**

Basel

**Company/Legal Entity**

Novartis Pharma AG

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

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