Associate Director, QC AnalyticalLocation Novato, California Workstyle Open to Hybrid Apply
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 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.
The Associate Director of Analytical QC testing operations is responsible for planning, supervision, and coordination of all activities within the QC Analytical department.
The role offers a unique opportunity for an operations minded leader to oversee a team of greater than 50 Quality Control professionals within the testing areas of in-process, release and stability. The testing from this function supports several product to patient modalities that include gene therapy, enzyme therapy, biologics, and small molecule. The role will collaborate closely with the Head of QC, QA and the Site Quality Head along with manufacturing leaders.
The Associate Director will focus heavily on operations while strategizing on process improvements to maximize productivity, efficiency with continuous analysis on QC operational processes to maximize ‘right-the-first’ to meet product deliverables according to plan. The leader in this role will also promote and foster a culture of Quality where compliance to method and organizational requirements is first and foremost the priority.
This position reports to the Quality Control Site Head and is a member of the Novato Site QC Leadership Team. The successful candidate ensures functional objectives are aligned with company goals and regulatory expectations.
- Lead personnel by developing and empowering managers and their on-floor teams to make decisions and ensure continued staff training and competence.
- Builds a culture of continuous improvement throughout with tangible systems that drive measurable performance.
- Collaborate with cross functional teams on key site and Global programs.
- Implement the concepts of Operational Excellence and deploy appropriate systems and processes to enable the efficient operation of a GMP laboratory supporting multiple platforms and modalities.
- Responsible for the functions compliance and ensuring timely closure of deviations, CAPA’s, and change controls.
- Maintain the laboratory in an inspection-ready state.
- Interface with other BioMarin departments (Regulatory Affairs, Quality Assurance, Facilities, etc.) and contractors as necessary.
- Interpret and apply applicable 21CFR, USP, EP. JP, and ICH regulatory guidelines and directives
- Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance
- Lead and implement initiatives that add value to the QC and site operations
- Optimization, troubleshooting and lifecycle management of analytical test methods in collaboration with product development and Quality Science and Technology.
- PhD with at least 4 years of experience in a relevant functional area
- M.S. with at least 6 years of experience in a relevant functional area
- B.S. with at least 8-10 years experience in a relevant functional area (at least 2 years in Quality Control).
The position requires:
- At least two-plus years in a cGMP laboratory, and or manufacturing experience as a leader of on-floor teams.
- Quality Control experience preferred.
- Demonstrate expertise with analytical methods used to assess biopharmaceutical products – preferred.
- Experienced operations leader within QC or manufacturing operations
- Lean Labs and, Six Sigma, and 5S experience.
- Ability to work independently, managing projects and meeting established timelines.
- Comfortable with directing the activities of other staff members.
- Computer literacy is required. Experience with Laboratory Information Management systems (i.e., LIMS) is preferred.
The position requires some knowledge of the following areas:
- Immuno Assays
- PCR (Polymerase Chain Reaction) based assays
- Total Organic Carbon Analysis
- Basic analytical skills
Direction and management of the managerial and supervisory leaders of the Analytical testing Quality control function. Typically 4-5 direct reports.
The position requires:
- Strong leadership skills
- Well developed organization skills with exact attention to details.
- Excellent written and verbal communication skills.
- Achieving Excellence
- Courage / Challenge
- Develop Self & Others
- GMP Acumen
- Critical Thinking & Evaluation
- Organizational Awareness
- Performance Management
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.
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.