Head of Pharmaceutical Development & Manufacturing
Egetis Therapeutics AB (publ) / Civilingenjörsjobb / Stockholm
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hela Sverige Visa alla jobb hos Egetis Therapeutics AB (publ) i Stockholm Join us in helping patients with rare diseases. At Egetis Therapeutics we challenge the status quo for the benefit of those in need. We offer an open, positive and supportive culture where everyone can be their best. Through trust, we work seamlessly across functions. As an employee you are empowered and encouraged to have an entrepreneurial spirit, enjoying an organization with conscious and efficient decision-making. We also take pride in having a great working climate!
Our vision is to bring unique life-improving therapies to patients with rare diseases. Egetis Therapeutics currently has two drug candidates in late-stage clinical development, and we are continuously seeking opportunities to grow our pipeline. For the lead drug candidate, Egetis submitted a marketing authorization application to the European Medicines Agency (EMA) in October 2023 and intends to submit a new drug application (NDA) in the US in mid 2024 under the Fast-Track Designation granted by FDA. We are now on an exciting journey to establish our own teams for product launches in Europe and North America.
We are committed, courageous, and collaborative people. Become a part of our inspiring environment. We care for the rare!
We have an Office downtown Stockholm where you are welcome to join us for work. However, we are flexible enabling you to find a work-life balance between the office and home.
Duties and responsibilities
• Accountable for strategy, planning, delivery and budget management of the Pharmaceutical Development & Manufacturing (PDM) contribution to the company's development projects
• * Development, maintaining and delivering all aspects of the pharmaceutical development plans including control of the scope, timing, resources, cost, quality and risk
• * Budget management of all development activities of API and drug product including life-cycle development, in collaboration with and as a part of Operations' Leadership Team.
• * Identifying and mitigating risks
• Act as Line manager for the PDM Team creating a collaborating, developing and trustful environment.
• An active member of Technical Operations Leadership contributing to delivery of defined goals on a timely manner.
• Review and risk assess in-licensing products/projects
• Accountable for establishment of the manufacturing process of API and drug product, for clinical studies and for commercial process through CMO's
• Accountable for regulatory CMC strategy from a scientific and technical viewpoint, documentation for clinical studies/programs and marketing authorizations (eg incl IND/IMPD), in close collaboration with Regulatory CMC.
• Accountable for clinical supply to the agreed quality, timeline and cost
• Accountable to plan and deliver the technical aspects of a tech transfer during development and for commercial supply
• Actively contribute to risk management and mitigation plans for CMO strategies for the company's project, development strategies for both API and DP as well as security of supply (dual sourcing, capacity etc)
• Responsible for technical aspects in supplier selection and supplier evaluation
• Accountable for the technical aspects of developing and managing maintenance and post approval processes
• Accountable for developing working processes and procedures relevant for the "PDM" department.
Competence requirements
Education:
• Scientific background: M.Sc. or PhD in Pharmacy or Chemistry.
Experience:
• Extensive experience of leadership positions within pharmaceutical industry (minimum 10 years)
• Extensive experience in all aspects of pharmaceutical development activities, including drug substance and formulation development, scale up, validation, control strategies, stability.
• Experience of outsourcing and collaboration with external partners (development activities and commercial manufacturing
• Proven experience of regulatory CMC; CMC regulatory strategies, compilation of pharmaceutical documentation for regulatory applications to EU and US (MAA/NDA) and for clinical trial applications, for several products
Skills, Abilities and Competencies
• You have a Strategic Mindset
• Resourcefulness and the ability to Optimize Work Processes
• Ability to Drive Results and Ensure Accountability
• Communicate Effectively
Naturally you share our Values:
• Courage - We challenge the status quo for the benefit of the patient
• Commitment - We operate with high ethical standards through an efficient organization to deliver top quality results
• Collaboration - Through trust, we work seamlessly across functions and with external partners
Selection and interviews will be conducted on an ongoing basis
Ersättning Enligt överenskommelse
Så ansöker du Sista dag att ansöka är 2023-11-29
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Egetis Therapeutics AB (publ) (org.nr 556706-6724)
Arbetsplats Egetis Therapeutics AB
Jobbnummer 8237629
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