Sr. Scientist 1

BioMarin Pharmaceutical Inc.•Novato, CA

42d

About The Position

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.

Requirements

Ph.D. in Biochemistry; Pharmaceutics Sciences, or related fields with 5+ years of industry experience
MS or BS with extensive industry experience
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.
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.
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.
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

Nice To Haves

preferably in solid oral dosage forms
experience in gene therapy drug product development is preferred
Familiarity with parenteral dosage forms, manufacturing processes, and packaging components is a plus

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.