Project Manager Fdf with Focus On Injectables

Vor 6 Tagen

Zurich, Schweiz two.jobs Vollzeit

For our Client Selectchemie AG we are looking for a Project Manager FDF with focus on injectables (100%).

About Selectchemie AG

Selectchemie AG is an independent Swiss company and since 1969 a first class distributor and service provider for the global Pharma and Swiss Nutrition industries. As exclusive distributor for leading suppliers of raw materials, APIs and excipients, complemented with our offering of boutique generic finished drug forms (FDF), we add value to our customers based not only on our products, but also with regulatory, quality, technical and supply chain services.

Join our team

Selectchemie is our customers’ partner for reliable commercial supply of our Finished Dosage Forms products (FDF). In addition to our robust supply chain we create value to our FDF customers with our Quality Assurance and Regulatory Affairs activities pre-launch, and during the entire commercial phase of our FDF products. We act virtually and cooperate with the best suitable partners for the project including API and finished dosage form partner.

You create our new product. You are a member of our project selection team deciding on our future portfolio, you are then executing the project and turn it into our product ready to launch. You are an experienced and hands-on project manager with a proven success rate in executing FDF development, tech’transfer and scale-up projects preferably in the generics pharma field. As an alternative you have solid expertise and track-record in manufacturing generics drug products. Your passion runs for injectable products.

Tasks

**Project management**:

- You are project leader and main contact person from project approval until product registration with authorities for internal and external stakeholders.
- You ensure the project’s success (timeline, budget, quality) via close coordination with contracting parties (e.g. CDMO) from project initiation to product launch by frequent communication and on-site visits.
- You challenge CDMO work and documents for efficient manufacturing process, compliance to cGMP, ICH, Regulatory, Pharmacopoeia and conditions specified in agreement.
- You proactively train yourself in product technology, formulation, quality and other relevant requirements, independently from CDMO work, necessary for successful project completion.

**Product / Project evaluation / Project set-up**:

- You support product/project evaluation process (providing potential opportunities, difficulties, challenges, possible solutions, product development capacities and capabilities).
- You support potential CDMO capability and capacity evaluation, and selection.
- You suggest, plan and implement project execution set-up incl. CDMO and other service providers.

**Agreements**:

- You prepare and negotiate development and tech’transfer agreements with dossier development partners and contract manufacturing organizations.
- You support License & Supply Agreement and Quality Technical Agreement preparation with product, regulatory, and GMP related information.

**Support during launch and commercial manufacturing phase**:

- You initiate and support further improvements in product technology and quality.
- You act as trouble-shooter after product launch. You consult internal and external partners for technical and analytical questions incl. deviations, OOS, and complaint investigations.

**Requirements**:
Required qualifications
- You have a technical background in Chemistry, Biology, Biochemistry or Pharmacy.
- You have at least 5 years of experience in production or formulation development of drug products for human use.
- You have hands-on experience in project management for drug product formulation, or product transfer projects for drug product for human use, ideally this experience comes from the generic drug product industry and injectable products.
- You are a hands-on person and you burn to make your projects meeting the goals.
- You are a project owner person, who is proficient in engaging multidiscipline and globally active teams for the needs of your project.
- You can challenge our service providers for efficient technical and commercial execution.
- Thanks to your creativity you can turn problems into solutions and opportunities.

**Benefits**:

- Entrepreneurial position in a dynamic and globally acting team
- Your input is key and you are part of creating our future success
- Intense cooperation with colleagues and across the entire hierarchy within Selectchemie
- Intense cooperation with CDMOs, customers/licensees on a global basis
- Short decision processes
- Travel of about 30%
- Attractive compensation package and possibility of remote work not exceeding 40% of working time

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