Xyzagen (ZiZaGen) is seeking a highly skilled scientist with a background in Pharmaceutical Sciences and extensive experience in immunoassay development and validation to lead our Small and Large Molecule Bioanalysis efforts. This role is designed for a technical leader who can transition from hands-on assay design to overseeing quality control, regulatory documentation, and staff management in a fast-paced GxP environment.

Xyzagen is a contract research lab supporting pharmacokinetics, ADME, bioanalytical, pharmacology, and non-GLP safety assessments. We are also a drug development consultancy providing regulatory advice to clients across nonclinical and clinical disciplines. At Xyzagen, we accelerate medicines to patients by partnering with life science innovators, contributing to multiple FDA approvals in the past six years. Xyzagen has provided strategic advice to early NIH funded biotechs, small and mid-size pharma and venture capital firms. At Xyzagen, we accelerate medicines to patients by partnering with life science innovators. In the past 8 years, we have worked with over 100 different innovators worldwide and have helped in the approval of multiple new therapeutics by the FDA. Xyzagen also conducts its own research on Kv7 channel openers within the therapeutic areas of Neurology and Pain.

Our strong team of scientists and subject matter experts enable our clients to have:

• Cost effective and informed decision-making
• Faster study start up for in vivo pharmacokinetic and safety assessment studies in rodents
• Wide range of contract research services to regulatory advice regarding pharmacokinetics of a client’s molecule and therapeutic program.

Additionally, we are expanding our laboratory and office space from 5,000 to 11,000 sq ft to continue to provide a resource center for early innovators within the Life Science and Biotech communities.

Job Responsibilities: Our Small and Large Molecule Bioanalysis Lead is responsible for supporting client projects by building and validating robust computational and experimental methods to describe biological response and drug concentration.

• Assay Development & Validation: Expert in either LC-MS/MS or ELISA assay development (from conception to assay qualification and operation). Lead the development, nonGLP qualification and sample analysis of cell-based assays, ADA, and biomarkers or small molecule sample analysis for client-specific drugs.
• Internal Regulatory Compliance: Ensure all laboratory activities and documentation are rigorous in support of nonGLP discovery based work.
• External Regulatory Compliance: Oversee client GLP assay development, validation and sample analysis.
• Technical Writing: Author and review SOPs, study protocols, qualification and sample analysis reports, and potentially pharmacokinetic sections of Clinical Study Reports (CSR) or regulatory filings (IND/NDA/BLA).
• Instrumentation: Understanding of LC-MS/MS or ELISA based methodologies. Mastery of advanced lab equipment, with specific proficiency in Dynex DSX, Cobas, and MSD, Sciex or Waters high resolution mass spectrometry platforms beneficial.
• Team Leadership: Experience as a Clinical Laboratory Supervisor managing and mentoring laboratory staff in efficient laboratory operation and also aseptic techniques and complex assay execution.
• Client Consultation: Act as a primary point of contact for clients, collaborating on immunoassay design and presenting data analysis results.
• Process Improvement: Lead initiatives to improve operational efficiency, automation, and quality management systems (QMS).

Qualifications:

• BS, MS, PhD or PharmD in Pharmaceutical Sciences, Bioengineering, Pharmacology, or a related field.
• Industrial experience in a bioanalytical R&D or clinical environment, with a proven track record of managing scientific teams: PhD/PharmD 0-2 years; MS 2-5 years; BS 3-8 years.
• Proficiency-level skills in software such as Gen5, Prism, LIMS, Smartsheet, Analyst and MSD data analysis software; instrument software and reporting software.
• Strong understanding of GxP guidelines and experience with FDA regulatory submissions.
• Superior writing and verbal presentation skills to internal and external audiences. Exceptional time management and self-motivation.
• A solutions-oriented, accountable "can-do" attitude suitable for a collaborative small-company environment.
• This position and compensation will range from Sr. Scientist to Sr. Manager depending on the individual’s qualifications.

Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. 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 frequently required to sit or stand for extended periods of time; use fine and gross motor hand skills in ensuring analytical equipment is maintained in operation.
• Must be able to speak and hear appropriately to communicate effectively with each associate or vendor.
• Specific vision abilities required by this job include close, distance and peripheral vision with the ability to adjust and focus.
• The employee on occasion will be required to lift and/or move up to 40 pounds.

Working Conditions:

• The noise level in the work environment is usually mild to moderate.

What We Offer:

• A competitive salary and meaningful equity compensation
• The compensation for this position will range from $90,000 to $120,000 depending on individual’s qualifications.
• A bright, collegial, highly motivated team working at the intersection of the most exciting area of science and technology
• Exceptional opportunities for learning and growth
• Company-paid holidays (closed between Christmas and New Year’s)
• Paid time off (2 weeks)
• Benefits (Medical, Dental and Vision)
• 401(k) plan + Safe Harbor Match + Profit Sharing + Defined Benefit retirement plan
• Flexible time off for personal business is not tracked
• Ability to work from home when possible
• Flexible schedule
• If relocating 50+ miles, potential for relocation stipend for relevant expenses

Xyzagen is a small company such that we are unable to sponsor visas for any candidate who is not eligible to work in the United States. Additionally, we cannot assist with the transfer of an employment visa from another company.