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Lead, QC In-Process

Location Novato, California
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. 

PURPOSE

The QC In-Process (QCIP) Lead is responsible for facilitation of review as well as some degree of execution for microbiological and analytical test methods on in-process intermediates and varying stages of drug products. This role is to serve as a model to analysts through exhibition of high productivity, accuracy, and flexibility, including maintaining a positive attitude regardless of circumstances. It is necessary that responsibilities are completed under minimal supervision and within cGMP guidelines. All responsibilities must involve a working knowledge that includes but is not limited to the following concepts: Protein determination by BCA, Bradford, and UV Absorbance, Enzyme activity, Endotoxin detection, Bioburden quantification, HPLC, Total Organic Carbon, microbial identification and challenge studies, aseptic techniques, and method validation. In addition to technical expertise, this role is intended to offer guidance for group and individual trajectories, and actively set a standard for teamwork and lab system quality, particularly during occasions that involve a high volume workload.

CHARACTERISTICS

Functional activities may include: technical review of a wide variety of microbiological and/or analytical assays, assisting with daily activity scheduling and maintenance of test sample throughput, provision of technical training and professional development coaching for less experienced staff, performing test methods as necessary, monitoring and coordinating purchase of lab supplies, facilitating investigations and equipment validation, some coordinating of process and method validation studies, and guiding implementation of improvement concepts for the further development of procedures or laboratory systems.

Key issues in all work assignments must be identified regardless of complexity. Employee is expected to follow and be proficient in knowledge and theory behind SOPs, understand the components and rationale behind requirements, apply consistent critical thinking skills to routine and non-routine work, and facilitate decision-making forums that involve suitable SMEs. He/she is also to possess an ability to independently recognize, initiate, and investigate any deviations from procedures, and be well practiced in fully supporting reasoning for conclusions.

Incumbent must generate work with a high level of productivity and accuracy, meanwhile limit instances of procedural error, and be capable of accepting and incorporating feedback. It is also necessary to exhibit effective time management, and to integrate newly learned information with situational factors toward rational outcomes. He/she can prioritize any objective as well as effectively delegate assignments to analysts, in that it is ensured each can be completed in a timely fashion. A QC Lead should consistently encourage active team discussion, make meaningful suggestions or direct collective contributions toward the completion of laboratory goals, and reinforce if not broaden staff awareness to the consequences of their work. Use of departmental goal knowledge to assist others with the prioritization of tasks is essential.

Employee must be able to interpret results against defined criteria, apply a degree of critical thinking toward responsibilities, and should exhibit mentorship of staff through initiative as technical trainer and investigator. He/she must demonstrate an ability to evaluate results against trend reports, contribute proactive troubleshooting of issues, and embrace an active role in following up on atypical results. With existing or newfound knowledge, it is also imperative to anticipate and focus toward active prevention of obstacles, or implementation of solutions that address consistent issues.

Relevant information from all job functions must be appropriately filtered, actively communicated and escalated to proper audiences. Attendance of all team meetings with some facilitation of discussions is essential, providing focus and accounting for the impact of department initiatives to the greater organization. He/she should also offer technical or improvement presentations along with QC representation within select cross-functional groups. Employee should be proactive and invested in his/her role, exhibit frequent volunteerism as work schedules permit, and engage with colleagues to foster mutual respect and ensure the collective environment carries an overall positive and productive atmosphere.

RESPONSIBILITIES

  1. Evaluate completed assay validity, calculate and summarize results, analyze data per expectations or specifications. Assist with compilation and verification of trend reports.
  2. Perform review for all assays and test records and oversee review of compliance records.
  3. Attend all team huddles and department meetings, support discussions and formulation of ideas for laboratory infrastructure improvements and method optimization.
  4. Offer timely communication with internal customers regarding incoming samples, develop strategies for receipt of atypical instances, assist with deciphering batch assignments, and reinforce agreed upon best practices across all assay types.
  5. Provide leadership with respect to assay scheduling and daily process prioritization.
  6. As times of high work volume may require, perform microbiological and/or analytical methods to facilitate in-process testing under applicable cGMP guidelines, as well as contribute to prompt reporting of results to meet required timetables.
  7. Qualify as trainer for a variety of responsibilities, with alignment toward an established progression of subject matter expertise. Provide troubleshooting and technical training to less experienced staff.
  8. Collaborate with co-workers to appropriately share general housekeeping activity assignments, and ensure systems for laboratory maintenance are adequate for creating a consistent state of inspection readiness.
  9. Monitor and assist with the control of laboratory supply and critical reagent inventories.
  10. Provide on-call coverage to support oversight of QC laboratory equipment functionality. Assist with coordination of CMMS processes such as equipment work orders and calibration due dates.
  11. Develop subject matter expertise in multiple lab systems or assay methodologies.
  12. Apply proactive communication upon occurrence of compliance risks and deviations from laboratory procedures, perform record initiation within required timeframes.
  13. Implement system improvements and procedural revisions, with emphasis on increasing laboratory efficiencies and safety.
  14. Exhibit a high degree of ownership for Unexpected Event Reports and CAPAs, with some level of participation of both Deviation and Quality Event write-ups.
  15. Coordinate support assays, deploy trend analysis and critical thinking to the progression of method validation, investigations, technical studies, and method transfer protocols.
  16. Represent QC needs within special project teams or cross-functional groups.
  17. Perform other responsibilities as deemed necessary
QUALIFICATIONS
  1. Bachelor of Science degree.
  2. 5-8 years of relevant laboratory experience, with 4-5 years of QC specific experience.
  3. Detailed knowledge of quality management systems, current Good Manufacturing Practices, expertise with QC principles and compliance requirements.
  4. Demonstrated working knowledge and critical thinking with respect to certified functional activities, with subject matter expertise on a number of technical modules or QC management systems.
  5. Excellent documentation, written and verbal communication skills are essential.
  6. Must possess the ability to perform routine and non-routine tasks under minimal supervision while modeling advanced measures of initiative, self-direction, objectivity and team advocacy.
  7. Ability and willingness to provide leadership to the entire group, with proficiency in both facilitating active and open discussion, and laying groundwork for logical decision making.
  8. Computer literacy is required, proficiency with Microsoft Word and Excel is essential, experience with Microsoft PowerPoint, Access, or Visio is desired.
  9. Working knowledge of statistics along with advanced software expertise, such as within JMP or LIMS, is optimal.
  10. Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or laboratory process requirements.


We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

~BIO

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Novato

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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