Scientist II / Senior Scientist, Bioanalysis

Enlaza Therapeutics; San Diego (CA); On-site; USD 125,000 - 195,000; Full time

Benefits offered by this job

Stock options

Comprehensive benefits package

Relocation assistance (if eligible)

Job summary

Enlaza Therapeutics in San Diego is seeking a Scientist II/Senior Scientist to join the Bioanalysis team within Pharmacology, Bioassay, and Translational Research. The role focuses on PK and immunogenicity assay development and data interpretation.

You will independently conduct bioanalytical analyses, maintain documentation, and contribute to cross-functional portfolio activities in a fast-paced, collaborative setting with on-site work.

Qualifications

• Bachelor’s degree in biochemistry, health sciences, or a related discipline with at least 7 years of experience in bioanalysis.
• Experience in development, optimization, maintenance and oversight of PK and immunogenicity assays; GLP setting desirable.
• Design, development, and implementation of PK, ADA and NAb assays meeting GxP requirements.
• Familiarity with current regulatory requirements for PK, ADA and NAb method validations.
• Intermediate to advanced use of SoftMax Pro and Prism.
• Demonstrated ability to communicate effectively within the discipline and cross-functionally.
• Keen attention to detail and strong organizational skills.
• Motivated independent contributor with a growth mindset in a fast-paced, team-oriented environment.

Responsibilities

• Independently support PK and immunogenicity assay development for portfolio activities.
• Maintain data reporting and lab documentation including notebooks, method qualification reports, and bioanalytical reports.
• Author bioanalytical method protocols and contribute to method characterization packages.
• Conduct bioanalytical sample analysis according to ligand binding methods.
• Contribute to peer review of data and documentation.
• Synthesize meta-analyses of bioanalytical datasets and communicate findings.

Skills

Bioanalysis expertise

PK & ADA & NAb assays

Communication skills

Attention to detail

Independent contributor

Education

Bachelor’s degree in biochemistry, health sciences, or related discipline

Tools

SoftMax Pro

Prism

Job description

Enlaza Therapeutics is a well-funded biotech company based in San Diego developing an innovative synthetic biology platform to create a disruptive new class of biologic therapeutics. We are dedicated to the development of these novel therapies to help patients suffering from cancer and other serious diseases.

Role Description:

We are seeking a highly motivated and skilled Scientist II/Senior Scientist to join the Bioanalysis team, based within the Department of Pharmacology, Bioassay, and Translational Research group. Reporting to the Associate Director of Translational Biosciences, the successful candidate will be responsible for the following.

Key Responsibilities:

• Independently support the scientific and technical development of pharmacokinetic (PK) and immunogenicity (ADA, NAb) assays in support of portfolio activities.
• Regularly maintain data reporting and affiliate documentation including but not limited to: laboratory notebook records, method qualification reports, and bioanalytical reports supporting exploratory sample analysis.
• Author bioanalytical method protocols and contribute to the development of method characterization packages.
• Independently conduct bioanalytical sample analysis in accord with established ligand binding methods.
• Contribute to peer review of internally-generated data and documentation.
• Independently synthesize meta-analyses of quantitative and qualitative bioanalytical datasets.
• Demonstrated ability to independently interpret bioanalytical data and communicate scientific findings to a wider audience.
• Participate in external vendor interactions to assist with assay troubleshooting and review/comment on assay performance data and related documentation, including but not limited to those related to method qualification and GxP method validation.
• Establish cross-functional relationships to provide and request support with the aim of advancing portfolio activities.
• Contribute to orderly and safe laboratory upkeep, including shared oversight of bioanalytical critical reagents, materials, equipment, and instrumentation.
• Work in compliance with established organizational Guidelines and operational best practices.

Requirements:

• Bachelor’s degree in biochemistry, health sciences, or a related discipline with at least 7 years of experience in bioanalysis.
• Demonstrated experience in the development, optimization, maintenance and oversight of PK and immunogenicity assays. Previous experience in a GLP setting is desirable.
• Experienced in the design, development, and implementation of PK, ADA and NAb assays supporting GxP requirements.
• Familiarity with the current regulatory requirements and landscape for PK, ADA and NAb method validations.
• Intermediate to advanced user of standard bioanalytical and visualization software: SoftMax Pro and Prism.
• Demonstrated ability to effectively communicate within discipline and cross-functionally.
• Keen attention to detail and strong organizational skills.
• Enthusiastic self-starter with a growth mindset and desire for continuous improvement. Motivated independent contributor with a demonstrated ability to succeed in a fast-paced, team-oriented environment.

Compensation:

In addition to a competitive compensation package with stock options, the company also offers a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance.

Job Type:

Full-time

Location:

Full-time on-site

Annual Salary Range (final salary will depend on job level, experience and skill):

$125,000 – 195,000

Supplemental Pay Types:

• -Annual Bonus: 10%
• -Equity
• 401(k)
• Employee assistance program
• Flexible spending account
• Flexible vacation
• Health insurance
• Life insurance
• Parental leave
• Paid holidays
• Relocation assistance (if eligible)
• Vision insurance
• Year-end shutdown

Enlaza Therapeutics is an equal opportunity employer committed to scientific excellence, innovation, and improving the lives of patients through transformative medicines.