Onsite: Novato

JOB DESCRIPTION

• The selected candidate will work in the Separations and Biophysical Assays team within the Analytical Sciences group to assist in the advancement of the company'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, biologics with a focus on method development and in-depth characterization. 
• The ideal candidate will be able to perform quality work under limited supervision, apply problem solving techniques to maintain accurate results, promote improvements, and assure a safe, stable, on-target operation within the laboratory. 
• The selected 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 (high-res) experience is also 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 is required.
• Experience with biochemical characterization methods is required:
• SEC, SCX, RP-HPLC experience is a must (Agilent/Waters/Thermo LC instruments)
• Capillary Electrophoresis (PA800 or BioPhase8800) based methods (SDS for size separation, glycan profiling)
• cIEF (Maurice) experience is highly desirable
• LC-MS (Orbitrap/QToF/QQQ) method development experience also 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 to solve them.
• Demonstrates attention-to-detail and “right-the-first time’ approach
• Excellent written and oral communication skills, with the ability to communicate complex information. Be able to 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.

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.

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.

The hiring range for this position is $40 to $47 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors.

 Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.

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