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Drug Product Lead Parenteral Iron
Job in
8152, Opfikon, Kanton Zürich, Switzerland
Listed on 2026-06-18
Listing for:
CSL Plasma Inc.
Full Time
position Listed on 2026-06-18
Job specializations:
-
Manufacturing / Production
Pharmaceutical Manufacturing, Validation Engineer
Job Description & How to Apply Below
We are looking for a DP Lead parenteral Iron to join our team in Zurich or St.Gallen, Switzerland.
Responsibilities- Scope and define technical work packages for projects such as CMC Development, Technology Transfer, and Continuous Improvement, including strategies, deliverables, and risks.
- Contribute to and review project execution plans, including technical transfer plans.
- Execute DP-related project work packages and tasks as a subject‑matter expert for aseptic and terminally sterilized parenteral product manufacturing.
- Proactively engage in periodic cross‑functional calls and meetings with internal and external team members.
- Prepare regular status updates on assigned work packages and tasks as part of project reporting and stakeholder management.
- Serve as the key technical contact for external partners and CMOs on assigned projects and routine manufacturing topics, including technical issue resolution, process changes, major deviations, and improvement initiatives.
- Act as a subject‑matter expert for internal stakeholders, performing Change Control impact assessments and supporting quality event investigations.
- Evaluate alternative, cost‑effective sourcing strategies for related products and attend technical due diligence visits at potential future CMOs.
- Visiting CMOs to oversee technical implementation and troubleshoot as needed.
- Provide background information, documentation, and technical advice to decision bodies and negotiation teams to ensure timely decision‑making.
- Compile and review technical documentation.
- Identify and assess opportunities to improve quality, compliance, and cost efficiency of established processes in collaboration with CMOs.
- Contribute to the development of business cases and decision‑making processes for implementation of change.
- Qualification in natural/life sciences or associated engineering (Biology, Biochemistry, Chemistry, Pharmaceutics, etc.), Bachelor/Master level or equivalent.
- Minimum 5 years’ experience in the pharmaceutical industry with direct experience in full‑scale commercial manufacturing of parenteral products (compounding, aseptic filling, sterilization, visual inspection).
- Self‑driven, fast learner able to take ownership and execute work packages independently in a matrix organization.
- Confident and proactive team player who collaborates effectively while working autonomously.
- Solid expert knowledge in sterile and aseptic fill & finish CMC development, equipment‑process qualification & validation, and manufacturing.
- High flexibility and willingness to travel, with experience in an external manufacturing environment.
- Familiarity with GMP requirements and guidelines related to CMC LCM activities, including Annex
1. - Experience with non‑transparent solutions.
- Know‑how across various parenteral primary packaging solutions (vials, ampoules, infusion bags).
- Experience in other drug product and finished product manufacturing & technology transfer, e.g. oral solid dosage forms.
- Ability to work effectively in a multicultural and international environment.
- Strong communication, analytical thinking, and problem‑solving skills.
- Ability to adapt to changing project requirements.
English fluently;
German is an advantage.
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit the accessibility statement.
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