RLT Formulation Project Leader
RLT Formulation Project Leader
Posted on :
07-07-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Job Description Summary
Create and drive with scientific & technological excellence the formulation development in close collaboration with operations analytics engineering and relevant SMEs QA and the project DPPL. Development activities includes among others: formulation and process-design control strategy quality risk management authoring of development documents and manufacturing instructions for technical and GMP manufacture incl. handling of deviation.Job Description
Role Responsibilities:
- Lead the development of formulations and manufacturing processes of Drug Products
- Support the development and the qualification of analytical methods together with the AS&T team leader in accordance with ICHs guidelines and internal SOPs. Participate as formulation expert to cross-functional project teams.
- Be accountable for all formulation and manufacturing process deliverables incl. scientific documentation for all assigned projects (Manufacturing instructions GMP documents deviation..).
- Guarantee technical support answering DP related questions in inspections and Health Authority requests throughout all phases of the project life cycle.
- Participate to the transfer manufacturing procedures to the relevant department (e.g. Technical Operations CDMO etc.).
- Ensure authoring of accurate comprehensible structured complete and legible documents to allow timely start of development trials process transfers and supply activities.
- Draft the CMC documents required to enable regulatory submissions (IND/IMPD Module3/NDA).
- Provide technical guidance to team members and work according to appropriate SOPs GLP GMP HSE and AdAcAp / Novartis guidelines.
- Proactively communicate key issues and any other critical topic in a timely manner to the appropriate management level to the TRD DPPL and/or to any other relevant project team member.
Essential Requirements:
- Minimum: PhD in Pharmaceutics or related sciences with a minimum of 3 years of proven experience within the pharmaceutical/biotech industry or a Masters degree with a minimum of 5 years experience.
- Fluent knowledge of English (oral and written). Desirable knowledge of site language.
- Demonstrated success in developing formulations with an emphasis in liquid sterile dosage forms.
- Technical expertise and detailed understanding of drug product production and control technologies.
- Experience with outsourcing and supervising work done by CRO/CMOs including technical overview of agreement set up.
- Experience in writing CMC documents for regulatory submissions and responding to health authority questions.
- Good basis of Quality Assurance (overall knowledge of GxPs).
Work Experience:
- Functional Breadth.
- Operations Management and Execution.
- Collaborating across boundaries.
Skills:
- Environment.
- Experiments Design.
- Health And Safety (Ehs).
- Laboratory Equipment.
- Manufacturing Process.
- Materials Science.
- Process Simulation.
- Project Management.
- Sop (Standard Operating Procedure).
- Technical Writing.
Languages :
- English.
Skills Desired
Environment Experiments Design Health And Safety (Ehs) Laboratory Equipment Manufacturing Process Materials Science Process Simulation Sop (Standard Operating Procedure) Technical Writing Waterfall ModelRequired Experience:
Senior IC
Employment Type
Full-Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
