Associate Director Chemical Drug Product and Device Technologies

Profile

Who We Are For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more. And the more people we reach, the more our impact can grow. We transform lives through genetic discovery. Our Culture Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard u2013 so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients. BioMarinu2019s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists, and support staff build and maintain BioMarinu2019s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patientsu2019 lives.u00A0u00A0Chemical, Drug Product and Device Technologies (CPDT) is comprised a team of scientists responsible for Drug Substance (synthetic), Drug Product and Device development. CPDT is for responsible for end-to-end development of chemical/synthetic molecules in collaboration with multi-disciplinary partners. CPDT team delivers stable formulations, reliable processes and technologies for drug product, combination products and administration components from early to late stage for various modalities including oligonucleotides, gene therapy, small molecule, peptides and proteins. We develop platform strategies to enable fast to patient approaches, including DS and DP development and manufacturing for outsourced programs.u00A0u00A0u00A0u00A0Role Summaryu00A0u00A0BioMarin is seeking a highly motivated individual with drug product development experience to lead CMC drug product partner team(s) for BioMarinu2019s programs on various modalities, including gene therapy, oligonucleotide, small molecule and peptide/protein.u00A0 The drug product partner team is responsible for all aspects of drug product and finished good to support the CMC deliverables. The drug product partner team comprises members from CPDT organization, Manufacturing, Packaging and Engineering Development, BioMarinu2019s network of CDMOs, and other cross functional teams. The scope of DP partner team includes but not limited to technology transfer, DP formulation development and optimization, primary packaging design, DP process validation execution, fill/finish process development & optimization, primary and secondary label development, DP packaging and shipping design and development, commercial product configuration design/development, oversee CMO manufacturing/testing/release, and CMO contracts.u00A0The main task of the CMC Drug Product Partner Team Lead (PTL) is to provide technical and team leadership to the members of the partner team, as well as representing the partner team at the CMC team level. The PTL is responsible and accountable for managing DP partner team(s) deliverables and communication to CMC and management. An understanding of the various functions represented within the partner team is required, to enable the PTL to provide oversight of cross-functional activities within the partner team, in order to bring about the successful planning, monitoring, and executing of deliverables of the CMC Program Execution Plan. Routine reporting of activities, issues, strategy, risks, etc. to CMC and management is expected. The PTL serves as a scientific monitor for formulation development, technology transfer and manufacturing at CDMOs. The role generally involves making use of scientific expertise and understanding of the industry, to develop and contribute to complex company objectives. Serving as a member of the Chemical, Drug Product and Device Technologies leadership team and contributing to the overall strategy, performance, and direction of the function. The PTL is expected to travel, at least 10% of time, for Person-in-Plant support at CMO sites, as per business needs. Experience with business contracts and e-business as well as knowledge of GMP is preferred. This candidate reports to the Vice President of CPDT organization.u00A0u00A0Role and Responsibilitiesu00A0Leads cross-functional CMC Drug Product partner team(s), working on various modalities including gene therapy, small molecule, peptide, and oligonucleotideu00A0Orchestrates with other partner teams to develop options/recommendations to CMCu00A0u00A0Responsible for timely and clear communication of all relevant information to and from the partner team to the CMC team and functional managersu00A0Responsible and accountable for managing the partner team deliverables, including timelines and scope, in support of the CMC Program Execution Plan and its performance. Will do this by coordinating with the team members and Functional Managersu00A0Ensures partner team meetings documents, including agendas, action items, and meeting minutes, are capturedu00A0Identifies, mitigates, and if necessary, escalates program and/or partner team deliverable risks (quality, timeline, scope) through CMCu00A0Accountable for creating, maintaining, and updating status of scheduled activities/milestones to the CMC PMu00A0Represents the partner team, not just a functional group in CMC meetingsu00A0Ad Hoc participation at Core Team meetings. as needed when PTL input is requiredu00A0Provides feedback on study protocols and reports to support formulation development, technology transfer or manufacturing at CMOs or CDMOsu00A0Clear understanding of experimental results and provides recommendations to CMC teams based on input from DP partner teamsu00A0Provides updates of project status, risks and mitigation strategies in the context of overall program goalsu00A0Reviews written technical reports, contributes to regulatory submission documentsu00A0Contributes to the overall strategy, performance, and direction of Chemical, Drug Product and Device Technologies functionu00A0u00A0Education Desired:Ph.D. in Biochemistry; Pharmaceutics Sciences, or related fields with 8 years of industry experienceu00A0u00A0MS with 12 yearsu00A0BS with 15 yearsu00A0u00A0Experience Required:Experience leading multi-disciplinary team and providing oversight of cross-functional activities within the team, in order to bring about the successful planning, monitoring, and executing of deliverables.u00A0u00A0Strong leadership and team management skills. A strong team player with good collaborative and people skillsu00A0Strong organization and prioritization skills, ability to facilitate and drive program forwardu00A0Strong written and verbal communication skills, and familiarity with representation on inter-disciplinary and cross-functional teams.u00A0u00A0Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.u00A0u00A0Highly motivated with the ability to resolve technical issues, develop and implement corrective solutions, be able to quickly adapt and respond effectively to changesu00A0u00A0The candidate will have a broad knowledge of regulatory, scientific, and technical issues concerning drug development applications.u00A0u00A0Must possess experience with formulation and drug product development.u00A0Experience in authoring/reviewing CMC sections for regulatory filings with health authorities.u00A0u00A0Excellent technical writing skills, experience authoring/reviewing development reports, batch records, regulatory filings, or other documents.u00A0u00A0Experience with designing formulation screening and optimization studies, characterization, testing, quality risk assessment and CMC regulatory guidance and filingsu00A0Experience working with CMO/CDMO is preferredu00A0u00A0Supervisor Responsibility:u00A0Noneu00A0u00A0Competencies Required:u00A0u2022 Strong leadership, negotiation, and influencing skillsu00A0u2022 Well-developed organization skills with exact attention to details.u00A0u2022 Strong deductive reasoning skillsu00A0u2022 Excellent written and verbal communication skills.u00A0u00A0Behavioralu00A0u2022 Accountabilityu00A0u2022 Achieving Excellenceu00A0u2022 Communicationu00A0u2022 Courage / Challengeu00A0u2022 Develop Self & Othersu00A0u2022 Judgementu00A0u2022 Reliabilityu00A0u2022 Teamworku00A0u00A0Technicalu00A0u2022 Technical expertiseu00A0u2022 Critical Thinking & Evaluationu00A0u2022 Influencingu00A0u2022 Organizational Awarenessu00A0u2022 Performance Managementu00A0u2022 Self-Knowledgeu00A0u00A0This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assignedThis is a hybrid role, based in Novato CA.u00A0 Hybrid is defined as onsite minimum 2 days per week in Novato, CA combined with remote days.u00A0 Candidate needs to be local to Bay Area - full relocation provided.u00A0 PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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