Head of Pharmaceutical Development
hace 1 mes
Your mission
The Head of Pharmaceutical Development will be responsible to lead and manage the pharmaceutical development activities internally and externally. Reporting to Chief Scientific Officer, your responsibilities will include defining, developing & optimizing products and product performance attributes; product development from formulations and through all phases of clinical development, with emphasis on early clinical stages; providing technical leadership & coordinating CMC regulatory efforts.
Responsibilities
Identify and develop formulation technologies applicable to potential product candidates. Manage the Pharmaceutical Development group in executing on drug development programs and projects. Provide scientific and technical expertise input into selection of new drug candidates and development programs. Lead the CMC aspects of product development programs. Part of the team responsible for the strategy, planning and implementation of the company’s research and development including clinical research programs. Ensure that sound technical data sufficient for regulatory filings is collected and appropriately reviewed. Write CMC sections of regulatory filings. Ensure that Pharmaceutical Development activities are conducted in compliance with applicable GMP/GLP and QSR requirements. Develop and budget resource forecasts. Identify new initiatives and infrastructure as needed to meet broader group objectives. Ensure that laboratory space and equipment are adequate, qualified as needed, and safe. Ensure staff is adequately trained. Work together with peers on key aspects and strategy of Ferrer Intellectual Property. Coordinate with other functional groups to ensure timely delivery of clinical trial materials for clinical studies and supplies for nonclinical studies. Work closely within the R&D organization with Business Development to identify, evaluate and recommend new concepts for product candidates in Ferrer’s pipeline. Lead effort to prepare data packages to support post-approval CMC changes. Serve as Subject Matter Expert during interactions with regulatory authorities. Ensure compliance with quality standards in the Analytical Development laboratory and in the Pilot Plant. Provides guidance, mentoring, and development of staff; ensures the team has appropriate skills, capabilities, and resources to meet current and future business needs.Why Ferrer?
Make a positive impact in society Participate in volunteering activities Grow in a culture of trust, responsibility, and constructive feedback Enjoy a flexible working model & collaborative office experience to enable innovation and teamworking Make a real difference to the team and to yourself Take advantage of opportunities for development & learning Discover a range of benefits to support your physical, emotional and financial wellbeing Customize your remuneration and benefit
Requirements
What you’ll need to succeed
You will rock at this company if you are a person with empathy, humility, curiosity and optimism.
You will rock at this role if you match with:
MS/PhD degree in in chemistry, biochemistry, pharmaceutical science, chemical engineering or equivalent. At least 10-12 years’ experience in pharmaceutical technical development disciplines. At least 3-5 years of leadership experience at the department and/or larger team level, including recruiting/coaching high performing teams. Proven track record of successful product development. Experience and knowledge across a broad range of different pharmaceutical technologies. Innovative and creative scientist shown through published papers and patents. A highly motivated self-starter with strong interpersonal skills including the use of influence and negotiations to successfully align and complete projects with both internal and external collaborators and “customers”. Proven ability to manage and simultaneously advance multiple tasks and projects at strategic and operational level. Proven leadership ability. Able to multi-task in dynamic environment. Sound decision-making and judgement. Experience with EMA and understanding of regulatory requirements. Organized and able to lead a functional group of high-level individual contributors, and also cross-functional teams, utilizing solid interpersonal and team skills. Excellent communication skills, both verbal and written. Strong background in more than one of the following: chemistry, analytics, drug development. Working understanding of cGMP and QSR regulations and guidance applicable to the development of productsIf this great challenge matches your profile, then we are waiting for you
At Ferrer, we guarantee equal treatment and opportunities in recruitment, avoiding prejudices and stereotypes for any reason in the processes of access to the company, assessing only objective criteria such as professional and academic skills and work experience.
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