Bioassay Associate Director

San Diego, CA - USA

Monthly Salary: Not Disclosed

Posted on: 5 hours ago

Vacancies: 1 Vacancy

Job Summary

Leadership & Strategic Management

Team Oversight: Directly manage non-leadership employees and group leaders; handle scheduling training and fostering teamwork/morale.
Operational Excellence: Ensure laboratory operations meet the highest quality efficiency and safety standards (including Health Safety & Environmental responsibilities).
Strategic Planning: Identify departmental unmet needs focus on team time management and implement LEAN projects or new technologies.
Client Relations: Act as the primary technical contact for sponsors to coordinate studies and ensure expectations are met.

Technical Responsibilities

Method Development: Lead the development qualification and validation of cell-based analytical test methods for drug products and drug substances. Design studies to elucidate the cellular mode of action (MoA) of drugs and characterize drug-target interactions and signaling pathways
Assay Execution: Perform tissue culture-based potency assays ELISAs and molecular biology techniques (qPCR ddPCR flow cytometry DNA/RNA extraction/purification).
Laboratory Support: Maintain multiple cell lines prepare solutions/culture media and utilize automation and advanced pipetting techniques.
Technical Resource: Serve as the internal expert to resolve complex technical problems and oversee the onboarding of new instrumentation.

Quality Compliance & Documentation

Regulatory Oversight: Ensure strict adherence to GXP (GMP/GLP) compliance; interface with the FDA and other regulatory agencies as needed. Track record of developing and validating GMP methods to support drug commercialization.
Scientific Review: Serve as the final reviewer for scientific rigor conclusions and the quality of reports sent to customers.
Technical Writing: Author SOPs policies and procedures; maintain accurate records and ensure the integrity of all laboratory work.
Accountability: Take ownership of reporting errors deviations or Out of Specification (OOS) occurrences promptly.

Qualifications :

Degree: Bachelors Masters or Doctorate in Biology Chemistry Biochemistry or a related physical sciences

Experience Levels:

Ph.D. with 10 years of related experience.
Masters with 15 years of related experience.
Bachelors with 20 years of related experience.
Authorization: Must be authorized to work in the U.S. indefinitely without sponsorship.

Essential Skills & Attributes

Communication: Exceptional oral and written communication skills for technical writing client interaction and professional peer engagement.
Computer Literacy: Advanced proficiency in Excel (formulas and linking spreadsheets) and general scientific software.
Professionalism: High attention to detail self-motivated adaptable and willing to work overtime when necessary to meet group deadlines.

Additional Information :

Position is full-time first shift Monday - Friday 9:00am - 5:00pm. Candidates currently living within a commutable distance of San Diego CA are encouraged to apply.

The pay range of this role is $150000 - $180000 at a Associate Director or Director level depending on related experience.

Excellent full time benefits including comprehensive medical coverage dental and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

Employment Type :

Full-time

Leadership & Strategic ManagementTeam Oversight: Directly manage non-leadership employees and group leaders; handle scheduling training and fostering teamwork/morale.Operational Excellence: Ensure laboratory operations meet the highest quality efficiency and safety standards (including Health Safet...

Leadership & Strategic Management

Team Oversight: Directly manage non-leadership employees and group leaders; handle scheduling training and fostering teamwork/morale.
Operational Excellence: Ensure laboratory operations meet the highest quality efficiency and safety standards (including Health Safety & Environmental responsibilities).
Strategic Planning: Identify departmental unmet needs focus on team time management and implement LEAN projects or new technologies.
Client Relations: Act as the primary technical contact for sponsors to coordinate studies and ensure expectations are met.

Technical Responsibilities

Method Development: Lead the development qualification and validation of cell-based analytical test methods for drug products and drug substances. Design studies to elucidate the cellular mode of action (MoA) of drugs and characterize drug-target interactions and signaling pathways
Assay Execution: Perform tissue culture-based potency assays ELISAs and molecular biology techniques (qPCR ddPCR flow cytometry DNA/RNA extraction/purification).
Laboratory Support: Maintain multiple cell lines prepare solutions/culture media and utilize automation and advanced pipetting techniques.
Technical Resource: Serve as the internal expert to resolve complex technical problems and oversee the onboarding of new instrumentation.

Quality Compliance & Documentation

Regulatory Oversight: Ensure strict adherence to GXP (GMP/GLP) compliance; interface with the FDA and other regulatory agencies as needed. Track record of developing and validating GMP methods to support drug commercialization.
Scientific Review: Serve as the final reviewer for scientific rigor conclusions and the quality of reports sent to customers.
Technical Writing: Author SOPs policies and procedures; maintain accurate records and ensure the integrity of all laboratory work.
Accountability: Take ownership of reporting errors deviations or Out of Specification (OOS) occurrences promptly.

Qualifications :

Degree: Bachelors Masters or Doctorate in Biology Chemistry Biochemistry or a related physical sciences

Experience Levels:

Ph.D. with 10 years of related experience.
Masters with 15 years of related experience.
Bachelors with 20 years of related experience.
Authorization: Must be authorized to work in the U.S. indefinitely without sponsorship.

Essential Skills & Attributes

Communication: Exceptional oral and written communication skills for technical writing client interaction and professional peer engagement.
Computer Literacy: Advanced proficiency in Excel (formulas and linking spreadsheets) and general scientific software.
Professionalism: High attention to detail self-motivated adaptable and willing to work overtime when necessary to meet group deadlines.

Additional Information :

Position is full-time first shift Monday - Friday 9:00am - 5:00pm. Candidates currently living within a commutable distance of San Diego CA are encouraged to apply.

The pay range of this role is $150000 - $180000 at a Associate Director or Director level depending on related experience.

Excellent full time benefits including comprehensive medical coverage dental and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

Employment Type :

Full-time

Key Skills

Program assessment
FDA Regulations
Manufacturing & Controls
Program Evaluation
budget forecast
Research Experience
Operations Management
Research & Development
Strategic Planning
Contract Management
Leadership Experience
negotiation

Apply Now

About Company

Eurofins

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eur ... View more

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