The selected candidate will work in the Separations and Biophysical Assays team within the Analytical Sciences group to assist in the advancement of BioMarin's therapeutics for clinical evaluation and potential commercialization. The candidate will be responsible for method development (separations), provide routine testing and characterization support to partner groups to help with early candidate selection, process development, and drug substance and drug product process characterization. The ideal candidate will have hands‑on experience working with biologics including but not limited to proteins, peptides, protein‑conjugates, enzymes, and biologics with a focus on method development and in‑depth characterization. The candidate should possess excellent analytical, 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 Separations and Biophysics group within Analytical Sciences.
- Be a hands‑on presence in the laboratory, supporting biophysical/biochemical assay development and qualification using HPLC and CE (must have) for various modalities (preferably biologics). LC‑MS experience desirable.
- Provide routine analytical characterization & testing support to partner groups including Upstream and Downstream PD, Formulations, and Research & Early Development (RED).
- Document experimental results in the company electronic lab notebook (Benchling), author procedures, and contribute to technical documentation (test methods, development reports).
- Actively participate in the operational aspects of the laboratory by conducting safety inspections, lab organization, ordering supplies, and performing routine equipment maintenance.
- Present scientific literature and results from ongoing studies at group meetings and other discussion forums at the company.
- Other duties as assigned.
Required Skills
- Hands‑on experience in the biotechnology industry or academic setting with a broad range of analytical techniques focused on analytical testing and characterization for proteins, peptides, and protein‑conjugates.
- SEC, SCX, RP‑HPLC experience with Agilent/Waters/Thermo LC instruments.
- Capillary Electrophoresis (PA800 or BioPhase8800) based methods (SDS for size separation, glycan profiling).
- cIEF (Maurice) experience highly desirable.
- LC‑MS (Orbitrap/QToF/QQQ) method development experience desirable.
- Technical understanding of all aspects of analytical testing, phase‑appropriate regulatory requirements, method qualifications, and method transfers.
- Ability to independently troubleshoot issues, ideate, and develop insights into technical challenges and propose solutions.
- Demonstrates attention‑to‑detail and “right‑the‑first‑time” approach.
- Excellent written and oral communication skills, with the ability to communicate complex information and present data/ideas to functional and cross‑functional teams.
- Ability to influence others effectively and develop collaborative relationships with partner teams.
- Familiar with use of statistical software, electronic document management, and laboratory information management.
- Ability to effectively analyze complex problems and present results effectively within and beyond the department.
- Ability to flexibly adapt to changing business needs and meet timelines.
- Strong organizational skills with the ability to effectively multi‑task and prioritize.
Desired Skills
- Experience in method development, qualification, and transfer to/from other laboratories such as development, quality control.
- Knowledge of biopharmaceutical process development is a plus.
- Experience with automation is a plus.
- Experience working in a cross‑functional environment.
- Good understanding of root cause analysis methodology.
Education
- Bachelor’s degree in Chemistry, Biochemistry, Analytical Chemistry, Chemical Engineering or a related field with 6+ years of experience in a Biologics or Pharmaceutical environment.
- Master’s degree in Chemistry, Biochemistry, Analytical Chemistry, Chemical Engineering or a related field with 4+ years of experience in a Biologics or Pharmaceutical environment.
WORK ENVIRONMENT / PHYSICAL DEMANDS
This role is primarily a laboratory position; contact with chemicals is part of the job. The role is fully onsite (5 days a week, 8‑hour days) with occasional evening or weekend work required. 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.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock and vibration. The noise level in the work environment is usually moderate.
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, knee crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities in this job include close vision, depth perception and ability to adjust focus.
EQUIPMENT
Analytical laboratory equipment.
Equal Opportunity Employer / Veterans / Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.