Associate Director, Chemical, Drug Product and Device Technologies (REMOTE)

Location:  remote, United States Category: Technical Development

Description

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 – 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.

BioMarin’s 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 BioMarin’s 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 patients’ lives. 

 

Chemical, 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.  

 
 
Role Summary
 
 
BioMarin is seeking a highly motivated individual with drug product development experience to lead CMC drug product partner team(s) for BioMarin’s programs on various modalities, including gene therapy, oligonucleotide, small molecule and peptide/protein.  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, BioMarin’s 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. 

The 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. 

 
Role and Responsibilities 

  • Leads cross-functional CMC Drug Product partner team(s), working on various modalities including gene therapy, small molecule, peptide, and oligonucleotide 
  • Orchestrates with other partner teams to develop options/recommendations to CMC  
  • Responsible for timely and clear communication of all relevant information to and from the partner team to the CMC team and functional managers 
  • Responsible 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 Managers 
  • Ensures partner team meetings documents, including agendas, action items, and meeting minutes, are captured 
  • Identifies, mitigates, and if necessary, escalates program and/or partner team deliverable risks (quality, timeline, scope) through CMC 
  • Accountable for creating, maintaining, and updating status of scheduled activities/milestones to the CMC PM 
  • Represents the partner team, not just a functional group in CMC meetings 
  • Ad Hoc participation at Core Team meetings. as needed when PTL input is required 
  • Provides feedback on study protocols and reports to support formulation development, technology transfer or manufacturing at CMOs or CDMOs 
  • Clear understanding of experimental results and provides recommendations to CMC teams based on input from DP partner teams 
  • Provides updates of project status, risks and mitigation strategies in the context of overall program goals 
  • Reviews written technical reports, contributes to regulatory submission documents 
  • Contributes to the overall strategy, performance, and direction of Chemical, Drug Product and Device Technologies function 

 

Education Desired:

Ph.D. in Biochemistry; Pharmaceutics Sciences, or related fields with 8+ years of industry experience  
MS with 12+ years 
BS with 15+ years 
 

Experience 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.  
  • Strong leadership and team management skills. A strong team player with good collaborative and people skills 
  • Strong organization and prioritization skills, ability to facilitate and drive program forward 
  • Strong written and verbal communication skills, and familiarity with representation on inter-disciplinary and cross-functional teams.  
  • Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.  
  • Highly motivated with the ability to resolve technical issues, develop and implement corrective solutions, be able to quickly adapt and respond effectively to changes  
  • The candidate will have a broad knowledge of regulatory, scientific, and technical issues concerning drug development applications.  
  • Must possess experience with formulation and drug product development. 
  • Experience in authoring/reviewing CMC sections for regulatory filings with health authorities.  
  • Excellent technical writing skills, experience authoring/reviewing development reports, batch records, regulatory filings, or other documents.  
  • Experience with designing formulation screening and optimization studies, characterization, testing, quality risk assessment and CMC regulatory guidance and filings 
  • Experience working with CMO/CDMO is preferred 

 
Supervisor Responsibility: None 
 
Competencies Required: 
• Strong leadership, negotiation, and influencing skills 
• Well-developed organization skills with exact attention to details. 
• Strong deductive reasoning skills 
• Excellent written and verbal communication skills. 
 
Behavioral 
• Accountability 
• Achieving Excellence 
• Communication 
• Courage / Challenge 
• Develop Self & Others 
• Judgement 
• Reliability 
• Teamwork 
 
Technical 
Technical expertise 
• Critical Thinking & Evaluation 
• Influencing 
• Organizational Awareness 
• Performance Management 
• Self-Knowledge 
 
This 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 assigned

This is a remote role.  Team is based in Novato, CA but candidate can be based anywhere in United States, with a willingness to accommodate PST business hours.


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.