Manager/Sr.ManagerLocation Novato, California Workstyle Open to Hybrid Apply
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
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.
The Chemical, Drug Product and Devices Technologies (CPDT) group, which is under the Technical Development organization, contributes to and aligns with BioMarin' s mission of developing and commercializing innovative biopharmaceuticals for serious diseases and medical conditions. The CPDT group leads the development of stable, reproducible, and scalable drug products and devices that are safe for non-clinical, clinical, and commercial use. Additionally, CPDT aims to ensure an end-to-end chemical and manufacturing processes development for small molecules and oligonucleotides drug substances. In addition to in-house product development, CPDT also engages in collaborative partnership with contract manufacturing organizations (CMOs) to expedite development of selected drug product candidates.
This individual contributor will work in the CPDT group to assist in the advancement of BioMarin’ s therapeutics for clinical evaluation and potential commercialization. In collaboration with a cross functional teams, key stakeholders as well as external partners, the individual will establish, monitor, and manage project milestones while ensuring compliance with BioMarin’ s quality standards. As the role cuts across formulation and device development, working knowledge of manufacturing and fill finish processes for small molecules, biologics, oligonucleotides and or gene therapy drug products is ideal.
The position requires the following core competencies:
•Understanding of quality systems and GMP processes
•Working knowledge of drug product development process
•Project management expertise
•Organizational and communication skills
•Negotiation and influencing skills
Additionally this individual will:
- Facilitate selection, establishment, maintenance and decommissioning of strategic CMO partners
- Assist with contract and QTA negotiations as well as compliance audits
- Provide quality oversight for outsourced manufacturing, testing, packaging, and release procedures/activities
- Review and approval of Master and executed batch records as well as other GMP documents
- Ensure projects are executed in alignment with BioMarin’s quality standards and manage their timely completion
- Work with subject matter experts to support the design/review/approval of development study documents (i.e. prototype screening, characterization, stability, fill-finish compatibility etc.)
- Manage technology transfer activities to and between contractor sites, encompassing process, analytical and logistical aspects
- Evaluate contract manufacturing organization for fit with BioMarin development project requirements by leveraging knowledge on contractors’ landscape through interaction with candidate organizations, site visits and attendance at trade shows.
- Coordinate assessments of process changes, change requests, deviation and out of specification findings
- Ensure quality issues are investigated and appropriate corrective actions are implemented
- Prepare and deliver effective oral presentations at relevant department and cross functional meetings
- Manage change requests, deviations, CAPAs on TrackWise
- Manage CMO meetings and project directory
- Provide Person in Plant (PIP) oversight for clinical CMOs, as needed
- Interact with various internal and external organizations.
- Engage with members of Chemical, Drug Product and Device Technologies, Analytical Sciences, Legal, Supply Chain, Clinical Operations, Global External Operations, Quality Control, Manufacturing, Regulatory, and Contract Manufacturing, Purchasing groups to jointly advance compounds through product development process.
- Interact with external parties (CMOs, contract laboratories, equipment Vendors, excipient suppliers etc.)
- Manager: 4+ years of experience (2+ years with Masters) with > 2 years of supervisory role in pharmaceutical or biotech setting.
- Sr. Manager: 6+ years of experience (4+ years with Masters) with > 2years of supervisory role in pharmaceutical or biotech setting.
- Experience managing a lab, preferred.
- Able to work at the Novato, CA site a minimum of 2 days a week.
- Excellent interpersonal, verbal, and written communication skills
- Strategic/critical thinking and problem-solving skills
- Understanding of drug product development and GMP processes
- Ability to facilitate meetings, take accurate notes and communicate commitments
- Work collaboratively and effectively in cross-functional teams
- People management skills—efficiently leverage resources to meet project milestones
- Proficient with MS Word, Excel, and PowerPoint
- Experience with managing quality investigations
- Strong leadership and PO generation and accrual management.
- Technical expertise in drug product and device development, preferred.
- Knowledge of risk management tools as Fishbone, Failure Mode Effects Analysis, etc, preferred.
- Experience with oversight of phase appropriate GMP requirements during early phase development, preferred.
- Proficiency with eQMS (TrackWise) and eCDMS (Veeva) is preferred
- Experience establishing best practice processes, a plus
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.