Director of Analytical Development - Build a Team - Small

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Job description

The Director will help build a strong team to develop analytical methods for a wide diversity of biological molecules ranging from nucleotide analogues, small molecules, polymers, and enzymes. The successful candidate will be expected to scientifically lead the analytical team to develop and validate analytical methods. A deep practical experience applying chromatographic and spectroscopic methods such as NMR, FTIR, UV/Vis/Fluorescence spectroscopy, Gas Chromatography, Mass Spectroscopy to the detection, characterization, and quantification of target compounds and impurity detection in complex biological matrices is required. A working knowledge of developing analytical methods for enzymes is also preferred. The role will be expected to identify and bring in-house additional analytical technologies or methods as needed. The position requires the ability to concurrently manage multiple projects that require the development and application of analytical methods for characterizing and QC'ing materials generated in house or externally.

Once the methods are established, the role will be working across the organization to establish manufacturing tolerances, perform guard banding studies and help establish specifications for a number of key compounds. The position will be based on RWC site (non-remote) and will be reporting directly to the Vice President of Reagent Development and will be working closely with a multidisciplinary team including the Senior Director of Chemistry, Senior Director of Reagent Development, and Associate Director of Sequencing as well as a variety of contract manufacturers, You will be part of a close-knit team of people who are focused, driven, and willing to do whatever it takes to keep the department running. This is a very exciting time to join our growing Genapsys team as the technology is rapidly scaling and approaching market adoption.

• Fundamental understanding in chromatographic and spectroscopic methods such as HPLC, GPC, NMR, FTIR, UV/Vis/Fluorescence spectroscopy, Gas Chromatography, Mass Spectrometry and ability to apply that knowledge to the characterization of chemical compounds and polymers.
• Must-Have hands-On experience developing analytical methods/assays to identify gaps in our analytical methods and either bring them in-house or work with outside analytical companies to expand our analytical capabilities.
• Must-Have hands-on experience developing and validating analytical methods/assays and the ability to apply that knowledge to establish quantitative assays for a variety of enzymes.
• Apply the analytical methods for establishing the identity and purity of raw materials generated both in-house and externally.
• Apply the analytical methods and participate in guard banding studies to establish purity requirements in order to ensure performance on Genapsys' sequencing platform
• Apply the analytical methods and participate in studies to establish shelf-life of the raw materials as well as final product components.
• Once specifications and methods are established, transfer the information to the Quality Department and relevant external partners.
• Apply root-cause-analysis and FMEA fundamental concepts for all reagent material issues.
• Communicate results effectively to stakeholders, external vendors, and other interested parties.
• Create and Write methods and SOPs
• Record, analyze and interpret experimental results.
• Document results in technical reports and present data at team meeting

Qualifications:

• PhD degree in Chemistry, Analytical Chemistry, Biochemistry, or equivalent discipline.
• Strong hands on technical experience in establishing and validating analytical methods such as HPLC, GPC, GC-MS, MS, NMR, UV/Vis/Fluorescence.
• Hands-on experience developing quantitative assays for enzymes is highly desired.
• 5 - 10 years industrial experience working with and applying analytical methods to establish product specifications.
• At least 5 years managing, training and mentoring junior staff.
• Success and interest in contributing to a diverse multi-disciplinary team.
• Strong communication and organizational skills with the ability to manage projects independently.
• Strong technical writing skills and experience writing SOPs desired.
• The ideal candidate will possess a high level of independence, while being able to seek out others in a collaborative spirt to achieve department goals and further our corporate mission.

Benefits we offer:

• Competitive compensation and generous stock options.
• Comprehensive, industry-leading medical, dental and vision benefits for employees and dependents.
• Pre-tax savings plans for health care, child care, elder care, public transportation and parking expenses.
• 401(k) retirement plan with matching employer contribution.
• Free daily catered gourmet lunches and snacks.
• For those emergency moments - long and short term disability, life insurance (2x salary) and an employee assistance program.
• Work with driven and enthusiastic colleagues in a fast-paced and entrepreneurial environment, the opportunity to work on problems that matter in a highly collaborative environment.

At this time, we can only consider applicants with authorization to work in the United States on a permanent, full-time basis; unfortunately, we cannot provide visa sponsorship.