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Associate 1, QC Microbiology (Validation)

Employer
BioMarin Pharmaceutical Inc.
Location
Ignacio, California, US
Salary
Competitive
Closing date
Jul 1, 2023

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Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Genetics, Biology
Salary Type
Salary
Employment Type
Full time
Who We Are

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 Culture

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.

PURPOSE

The QC Microbiology Associate is responsible for supporting the method validation program and coordinating and implementing assay method validations, including execution of studies for microbiological test methods on in process intermediates, bulk drug substance and drug product. The candidate should be able to complete work under minimal supervision, in accordance with cGMP guidelines, and have a good working knowledge of microbiological methodology, that includes but is not limited to the following, endotoxin, bioburden, microbial identification and environmental monitoring. He/she is to demonstrate efficiency while executing objectives that include but are not limited to the following: quality system investigations, metrics and trending, training, lab maintenance systems, equipment management, document management, coordination of outsourced testing, blanket PO management, and method development, optimization, validation and/or troubleshooting.

CHARACTERISTICS

The candidate must be able to interpret results against defined criteria and apply a degree of critical thinking as the subject matter expert (SME) to form conclusions and present data to management. He/she must demonstrate an ability to compare a wide range of data sources against trend reports and contribute to proactive troubleshooting of issues and/or atypical results.

In addition, the candidate should be detail-oriented, exhibit effective time management and communication skills,and be able to work in a team-oriented culture of open feedback. The candidate should also be able to anticipate and implement solutions that actively prevent and/or remove obstacles related to ongoing issues and allow for continuous improvement.

Key issues in all work assignments must be identified regardless of complexity. The chosen candidate is expected to follow and be proficient in knowledge and theory behind SOPs, understand the 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 should possess the ability to independently recognize, initiate, and investigate any deviations from procedures, and be versed in fully supporting reasoning for conclusions.

RESPONSIBILITIES

  • Define validation program requirements and develop/implement strategies for validation programs to ensure all validations are performed and adhere to current compendial requirements.
  • Develop experimental design for validation protocol execution and supplemental studies as appropriate. Coordinate and plan method validation activities, investigations and technical studies.
  • Ensure quality systems are in place and followed, and execute principal investigation of deviations, LIRs, excursions, adverse trend, and child or assessment records as needed.
  • Evaluate routine assay validity, calculate and summarize results, analyze data per expectations or specifications. Assist with compilation and verification of trend reports.
  • Aid in the preparation of monthly and quarterly reports for in-process and environmental monitoring data, review and analysis of testing trends and Microbial Identifications.
  • Coordinate troubleshooting efforts of instrumentation or reagents through hypothesis testing, laboratory notebook studies and communication with vendor technical support.
  • Support tracking of contract lab tests and review of data from these labs.
  • Plan and coordinate the development and publishing of investigational, comparability study, validation or method transfer protocols.
  • Initiate and lead validation or special laboratory studies and track data compilation, review, verification and analysis to completion.
  • Manage the creation, review and approval of technical and/or validation reports.
  • Apply proactive communication upon occurrence of issues or genesis of improvement concepts. Represent department needs as part of cross-functional teams while fostering collaboration in the deciphering of paths forward and action plans.
  • Readily mentor and develop staff within the method design space and/or technical aspects of QC objectives and build a scientific focused foundation for the team.
  • Perform other responsibilities as deemed necessary.


  • BASIC QUALIFICATIONS

    B.S. degree, or equivalent, in a biological or biochemical science and at least 5 years of experience in a pharmaceutical laboratory, with at least 2 years as part of a QC organization

    PREFERRED QUALIFICATIONS

    Candidate must be a motivated employee capable of working in a fast-paced environment to produce quality and timely results. Strong time management and organizational skills. Experience managing projects and processes. Strong people skills. Experience with meeting organization and facilitation. Practiced in technical training element and program deployment. Ability to foster a team-oriented environment. Experience authoring and reviewing SOPs, test records, work instructions, OJTs, and other controlled documents.

    LEADERSHIP QUALIFICATIONS
    • Continuously looking internally and externally for best practices and areas for improvement.
    • Provides clear instruction and direction to team members to assure fast action and effective completion of technical, laboratory and/or compliance related projects.
    • Leads by example with thorough, effective laboratory work and decision making that helps to motivate and inspire the team to broaden their knowledge base and elevate performance.
    • Understands patient and customer needs and builds relationships as required to meet department objectives.


    EXPERIENCE

  • Detailed knowledge of quality management systems, current Good Manufacturing Practices, longstanding expertise and practice with QC principles.
  • Ability to deliver all ideas and work with a compliance mindset and alignment with pharmacopeia regulations and international guidance documents.
  • Demonstrated working knowledge and critical thinking with respect to certified functional activities, with subject matter expertise on several technical modules or quality management systems.
  • Excellent documentation, written and verbal communication skills are essential.
  • Must possess the ability to perform routine and non-routine tasks under minimal supervision while modeling initiative, self-direction, objectivity and team advocacy.
  • Ability and willingness to provide input to the entire group, with proficiency in both facilitating active and open discussion and laying groundwork for logical decision making.
  • Working knowledge of cGMP regulations pertaining to test result disposition, stability protocol generation and execution and critical reagent program management, is desired.
  • Computer literacy is required, proficiency with Microsoft Word and Excel is essential, experience with Microsoft PowerPoint, Access, Project and/or Visio is desired.
  • Expertise with laboratory software functions, such as within MODA or LIMS, is optimal.
  • Fluency with experimental design and data trend / comparability evaluation per statistical models, with some advanced software experience such as with JMP or Power Pivot.
  • 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, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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