Associate Director, Assay Development NAT

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.Summary:The Associate Director of Product Development (AD Product Development) leads a a group of scientists and research associates working on complex research and development projects. This position requires experience with multiple product development projects and demonstrated success in leading the development of more than one diagnostic or blood screening nucleic acid test (NAT) from concept/feasibility to product launch. The AD Product Development position requires a strong working knowledge of regulations affecting blood screening and/or diagnostic products as well as experience in writing sections of BLA or PMA submissions. The position requires at least 10 years of experience with NAT methods and a solid foundation in biology, chemistry, molecular biology and/or biochemistry; a Ph.D. degree is strongly preferred. The AD Product Development requires a thorough understanding of Design Control and will be required to represent R&D on interdepartmental core teams. This role will assist PMO in the development of project plans (R&D budgets and timelines). The AD Product Development may also be asked to represent the company in outside technical meetings and support or take a lead role with Regulatory Affairs in meetings with the FDA or other regulatory agencies.Primary responsibilities for role:●Responsible for leading complex projects supporting research and/or product development goals and corporate strategy●Requires experience with multiple product development projects and demonstrated success in leading the development of more than one diagnostic or blood screening nucleic acid test (NAT) from concept/feasibility to product launch●Responsible for leading product development projects from concept/feasibility through product launch if needed; may also assume product development responsibility for projects that have completed research/feasibility within a different R&D team●May represent R&D on interdepartmental Core Teams for complex product development projects or in support of on-market products; this may be delegated for less complex projects; must be viewed as a leader on the core team●Responsible for managing the completion of all R&D Design Control tasks, including editing and updating sections of design control documents for which R&D is responsible●Responsible for the management of a portion of the overall R&D budget in line with corporate guidelines; will be required to work with PMO to develop project timelines and budget●Required to take lead role in writing/editing sections of BLA or PMA submission sections with minimal further editing by supervisor before submission; assist Regulatory Affairs Department in responding to questions from regulatory agencies in written form and may take a lead role in meetings/teleconferences with regulatory agencies●May be required to assist the VP of Product Development in development of presentations for outside technical meetings and may take lead role or assist in presentations; may be required to attend meetings with customers in support of commercial goals●May be required to prepare project updates to senior management●May take the lead role in writing abstracts and/or creating presentations for scientific conferences with minimal oversight and editing by supervisorAdditional Responsibilities:●Responsible for leading complex projects supporting research and/or product development goals and corporate strategy; will be responsible for leading product development projects from concept/feasibility through product launch if needed; may assume product development responsibility for projects that have completed research/feasibility within a different R&D●Requires experience with multiple product development projects and demonstrated success in leading the development of more than one diagnostic or blood screening nucleic acid test (NAT) from concept/feasibility to product launch●Must be viewed as a leader on the Core Team●Required to take lead role in writing/editing sections of BLA or PMA submission sections with minimal further editing by supervisor before submission; assist Regulatory Affairs Department in responding to questions from regulatory agencies (in written form) and may take a lead role in meetings/teleconferences with regulatory agencies●May be required to assist the VP of Product Development in development of presentations for outside technical meetings and may take lead role or assist in presentations; may be required to attend meetingsKnowledge, Skills, and Abilities:This role requires advanced knowledge of molecular test development with experience supervising a team of Research Associates and Scientists. Additionally, this position requires a thorough knowledge of Design Control and the general regulatory requirements for developing IVDs. The following are essential skills/competencies:Manage execution and build realistic plans

Promote teamwork

Communicate the vision

Make sound decisions

Education:B.A. /B.S. Molecular Biology, Chemistry, Biochemistry or related field.M.S. Molecular Biology, Chemistry, Biochemistry or related field (not required if candidate has a Ph.D degree)Ph.D. Molecular Biology, Chemistry, Biochemistry or related field (strongly preferred)Experience:10-12 years post graduate experience (including at least 10 years experience with molecular methods), with at least 5 years of industrial experience (including leading a product development project from concept/feasibility to launch)

Ph.D. with post-doctoral work is strongly preferred

Equivalency:Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.Occupational Demands:●Travel may be required●Must be available to participate in teleconferences with colleagues in Asia and/or Europe outside of normal working hours.EEO Minorities/ Disability/VeteransGrifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.Req ID: 270967