QC Analytical Technologies Scientist
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.
BioMarin is seeking a Molecular Biology, Biochemistry, or Analytical Scientist within the QC Analytical Technologies group (Scientist 1 / Scientist 2). The candidate will oversee special studies and manufacturing support for process optimization, process qualification, and deviation investigations. The scientist will potentially supervise up to five analysts. Activities include defining and executing scientific plans, tabulating and processing process and analytical data, and working with other scientists and team members. The Scientist 1 / Scientist 2 candidate will also assist with regulatory filings and serves as the QC representative for inter-departmental meetings.
The candidate will play a key role in product development and manufacture. Essential to this role is a strong knowledge base and broad expertise in biochemistry, molecular biology or other appropriate scientific qualification and the ability to lead and mentor scientific staff and collaborate with cross functional team members to execute product development. The candidate will be required to manage scientific development, implement and maintain plans and strategies to support manufacturing, provide scientific expertise, prepare reports and keep upper-level management informed of progress and problems. Previous experience with potency and purity test methods for gene therapy or protein therapeutics and cell culture is highly desirable. The candidate should have previous experience of leading teams and at least five years of experience in a GMP environment.
The candidate will serve as the most accessible source of expertise available to QC analysts working in the lab. By training, example and experience, the incumbent is expected to provide technical leadership, raising the performance level of all QC Analytical staff.
- Development, validation and transfer of analytical/bioanalytical methods used in BioMarin’s QC clinical and commercial testing operations supporting in-process, release and stability testing
- Design and execution of special studies for product development activities
- Provide technical support to manufacturing, Quality and QC during manufacturing and/or QC investigations
- Support the implementation of method training to support knowledge transfer
- Support improvement activities to ensure delivery of scientifically sound and efficient QC methods
This position will collaborate with internal and external stakeholders to support BioMarin’s clinical development and commercial manufacturing activities. Additionally, this position will collaborate with Regulatory and Product Quality to support CMC deliverables including content authoring and review of Quality owned sections for INDs/IMPDs, BLAs/MAAs and HA information requests and communications.
- Advanced degree (M.S., Ph.D.) in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 5 years of relevant experience is preferred
- Experience with analytical method development, validation and transfer as well as product characterization and analytical comparability
- Good knowledge of current Good Manufacturing Practices (cGMPs) and multi-national regulations
- Ability to travel up to 10% of the time
Preferred Experience, Special Skills, Knowledge
- Strong leadership skills and ability to effectively communicate up, down and across the organization
- Ability to effectively prioritize and deliver high-quality results on tight timelines
- Excellent written, verbal communication and presentation skills
- Outstanding problem-solving skills including the ability to devise and implement practical solutions to resolve complex issues
- Expert in growth of multiple human, animal, and insect cell lines is desirable.
- Familiarity with use of a computer (e.g., Proficient in Windows, Microsoft Word, Excel, and statistical software (such as GraphPad, Minitab, or JMP).
- Familiarity with a wide range of analytical technologies such as HPLC, ELISA, and/or bioassays.
- Strong critical thinking/problem solving skills.
- Proficient in the use of analytical software such as LIMS, Empower, ChemStation, and/or Softmax Pro.
- Experience in designing and executing large projects/studies is essential.
- Experience with or knowledge of Quality Control or GXP is required.
- High level of initiative, independence, and ability to work unsupervised.
- Manage and perform activities associated with validation and transfer of QC Methods used to support BioMarin’s in-process, release and stability testing programs including to contract testing organizations (CTOs), in-country test labs and strategic partners.
- Provide technical expertise for bioanalytical methods in QC, support the maintenance of method and analytical equipment performance
- Perform primary review of QC raw data and trend results as required
- Prepare and review documentation to cGMP standards – often for direct submission to pharmaceutical regulatory agencies
- Optimize and troubleshoot analytical methods
- Act as technical resource and train analysts in areas of expertise
- Conduct, support and document investigations to rapidly identify the root cause and to establish effective corrective action(s) with minimal delay
- Interpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directives
- Contribute to ensuring operations are executed in full compliance with cGMPs and multi-national regulations
- Provide technical support for site and product related inspections (e.g. Pre-Licensing Inspection (PLI) and periodic cGMP inspections)
- Write, review and approve Quality Control SOPs, specifications, method validation, verification and transfer protocols and reports
- Support Annual Product Review (APR) and Annual Report (AR) activities
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.