Biotechnology Project Manager Jobs in Santa Rosa, CA

Description
Who We Are
BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.
Guided by our purpose to develop medicines that make a profound impact on people's lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.
Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.
About Technical Operations
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.
Formulation and Product Technologies (FPT) is comprised a team of scientists responsible for , Formulation and Drug Product development. FPT is responsible for end-to-end development of chemical/synthetic and biologics molecules in collaboration with multi-disciplinary partners. FPT 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 small molecules, oligonucleotides, peptides and proteins/enzymes. We develop platform strategies to enable fast to patient approaches, including DP development and manufacturing for outsourced programs.
Role Summary
BioMarin is seeking a highly motivated individual with drug product development experience-preferably in solid oral dosage forms-to oversee drug product development and manufacturing activities. This role may be fulfilled as a subject matter expert (SME) in drug product formulation development or as a Drug Product Partner Team Lead.
The Drug Product Partner Team is responsible for all aspects of drug products and finished goods development in support of CMC deliverables. The team is cross-functional and includes representatives from Formulation Product Technology (FPT), Drug Substance, Analytical Development, Manufacturing, Packaging and Engineering Development, along with other key functional groups.
The successful candidate will bring broad and deep expertise in drug product development, including but not limited to technology transfer, formulation development (small molecules, Oligos, peptides) and optimization, primary packaging design, drug product process development, fill/finish process development and optimization, primary and secondary labeling and packaging development, and shipping design and qualification.
The individual is expected to routinely report on project activities, issues, strategies, and risks to CMC leadership and management. This role also serves as the scientific monitor for formulation development, technology transfer, and manufacturing activities conducted at CDMOs/CMOs.
The position requires the application of scientific expertise, industry knowledge, and sound judgment to contribute to complex company objectives. In addition, the individual will contribute to the overall strategy, performance, and direction of the function. Knowledge of GMP requirements is preferred.
Role and Responsibilities
• Plans experimental strategy and formulation development across non-clinical and clinical phases for small molecules, oligos, and peptides.
• Collaborates within a matrix organization (Research, PD, QC, Drug Substance, Analytical, MSAT, Manufacturing, CDMOs/CMOs, Market Planning, Regulatory) to deliver project objectives.
• Provides scientific guidance to junior scientists on experimental design, troubleshooting, data interpretation, and technical challenges.
• Designs experiments and technical strategies to address formulation and process issues.
• Leads drug product formulation development and optimization.
• Leads the cross-functional CMC Drug Product Partner Team and represents the team in CMC forums.
• Coordinates with other partner teams to develop recommendations and options for CMC decision-making.
• Interprets experimental outcomes and provides integrated recommendations to CMC teams.
• Ensures timely, clear communication between the Drug Product Partner Team, CMC team, and functional management.
• Identifies, mitigates, and escalates risks related to quality, timelines, and scope.
• Accountable for tracking and reporting milestones and deliverables to the CMC Project Manager.
• Represents the Drug Product team at Core Team meetings and is accountable for DP deliverables.
• Supports CDMO selection, due diligence, and site evaluations.
• Reviews and provides input on protocols and reports supporting formulation development, tech transfer, and manufacturing.
• Reviews technical documentation and contributes to regulatory submission content.
• Contributes to the overall strategy, performance, and direction of the Chemical, Drug Product, and Device Technologies function.
Education Required
Ph.D. in Biochemistry; Pharmaceutics Sciences, or related fields with 5+ years of industry experience
MS or BS with extensive industry experience
Experience Required

• Experience leading multi-disciplinary team and providing oversight of cross-functional activities within the team, to bring about the successful planning, monitoring, and executing of deliverables.
• Experience with designing parenteral formulation screening and optimization studies, experience in gene therapy drug product development is preferred.
• Hands-on experience in solid oral dosage form development, including pre-formulation and formulation of tablets, capsules, and oral solutions.
• Experience with parenteral drug product formulation development, characterization, testing, quality risk assessment and CMC regulatory guidance and filings.
• 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.
• 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.

Supervisor Responsibility
May lead 1-2 associates
Competencies Required
The position requires:
• 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.
Technical expertise

• Solid understanding and familiarity with pharmaceutical characterization and testing equipment such as HPLC (RP-HPLC, SEC, ion exchange chromatography), DSC, UV spectrophotometry, particle size measurement techniques, DLS, Differential Scanning Fluorimetry (DSF), and so on.
• Operational knowledge and experience with small molecules, oligos and peptides fill finish operation and tech transfer.
• Familiarity with parenteral dosage forms, manufacturing processes, and packaging components is a plus
• Critical thinking and evaluation
• Influencing
• Organizational Awareness
• Performance Management
• Self-Knowledge

Behavioral
• Accountability
• Achieving Excellence
• Communication
• Courage / Challenge
• Develop Self & Others
• Judgement
• Reliability
• Teamwork
Work Environment
Hybrid - would require 2-3 days onsite in Novato, CA
Note: 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.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.