JOB DESCRIPTION
The Analytical Services Senior Research Associate 1 is 100% onsite position currently anchored at the BioMarin campus of Novato, CA.
The selected candidate will work in the Analytical Services group of Analytical Sciences division to support phase appropriate activities; post commercial analytical method lifecycle improvements, method development and validation of analytical methods to support therapeutics for clinical evaluation and potential commercialization. The candidate will be responsible assay development, assay qualification, and characterization testing using routine and semi-routine analytical methods. The candidate will mentor laboratory services staff applying problem solving techniques to maintain accurate results, promoting improvements, and assuring a safe, stable, on-target operation within the Analytical Services Laboratory. The selected candidate should possess excellent understanding of GMP compliance, analytical techniques, organizational and communication skills and be a self-starter willing to work efficiently and collaboratively in a dynamic environment.
RESPONSIBILITIES
Primary responsibility is to support the Analytical Services subgroup within Analytical Sciences division under the direct supervision of the laboratory manager to utilize Analytical Services team resources to meet all requirements and requests from stake holders. The SRA1 will support DS and DP method development, validation, post commercial method assessments and assist with investigations and troubleshooting analytical method performance as well as support special projects for process improvements within Analytical Services.
Perform analytical assays and analyst review of samples submitted to Analytical Services, including but limited to: separation methods: size exclusion, reversed phase, ion exchange, hydrophobic interaction HPLC, spectral analysis, activity assays, total protein, cell-based bioassays, ELISA, chromatography, PCR, and capillary electrophoresis.
Oversee analytical testing of drug substance, drug product, and control samples according to laboratory procedures, report completion, data entry and internal audit activities.
Delegate responsibilities and assess the work of laboratory personnel, while providing guidance and motivation to drive maximum performance.
Collaborate with laboratory manager to evaluate resource requirements of projected work and adjust staffing allocation accordingly.
Assist in planning and execution of relevant experiments to support development and qualification of analytical assays /of existing enzyme replacements therapies, small molecules, oligo agents and biologics.
Oversee supply and equipment inventory to maintain optimal supply levels and ensure equipment repairs and preventative maintenance occur in a timely manner.
Skills
Required Skills:
The successful candidate will have an in depth understanding of the following
• Acute understanding of laboratory safety, hazardous materials and laboratory waste disposition.
• Technical understanding of all aspects of analytical testing, process controls, and characterization of APIs and pharmaceutical products.
• Understanding and working knowledge of the physical, chemical, and biological characteristics of the products.
• Demonstrates advanced team facilitation skills that consistently foster effective brainstorming and decision-making.
• Excellent written and oral communication skills, with the ability to communicate complex information.
• Ability to flexibly adapt to changing business needs and meet timelines.
• Strong organizational skills with the ability to effectively multi-task and prioritize.
• Experience working in a cross-functional environment.
• Interaction with other departments to work toward problem resolution.
• Strong influencing skills, able to recognize and advocate changes to improve business processes in line with senior managements vision.
• Strong understanding of root cause analysis methodology.
Desired Skills:
Experienced in method development, qualification, and transfer.
Understanding of Phase appropriate control requirements.
Understanding of GMP / GLP.
Knowledge of biopharmaceutical development is a plus.
Experience with mammalian cell culture is a plus
Experience with automation is a plus
Familiar with use of statistical data systems, electronic document management and laboratory information management.
Primarily a laboratory position; contact with chemicals is part of the job. The employee will be trained to use common lab equipment and minimize exposure to hazards. Desktop or laptop computer work is also a major component of the job.
Education
Bachelor’s Degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field with 6+ years of experience in a Biologics or Pharmaceutical environment.
Master’s Degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field with 4+ years of experience in a Biologics or Pharmaceutical environment.
