Associate Director, Analytical Development

Abzena

San Diego (CA)

On-site

USD 150,000 - 170,000

Full time

14 days+

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Job summary

A leading biopharmaceutical company is seeking an Associate Director of Analytical Development in San Diego. The role entails overseeing the Analytical Development team, maintaining high operational standards in the laboratory, and ensuring adherence to safety and quality regulations. Ideal candidates will have substantial experience in the biopharmaceutical industry, strong leadership skills, and a track record in developing and optimizing analytical methods critical for regulatory submissions.

Qualifications

8-10 years of relevant experience in the biopharmaceutical industry.
3-5 years of experience in a leadership role.
Extensive knowledge of USP, ICH, EP, FDA, 21 CFR.

Responsibilities

Responsible for oversight, leadership, and management of the Analytical team.
Maintaining the Analytical laboratory in a highly optimized functional state.
Ensure adherence to quality standards set by regulations.

Skills

Leadership

Communication Skills

Teamwork

Education

PhD in chemistry, biology, biochemistry, or related discipline

MS with 12-15+ years of relevant experience

Job description

Associate Director, Analytical Development

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Associate Director, Analytical Development

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With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.

Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.

We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.

We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.

The Associate Director will be accountable for the day-to-day oversight, leadership and direct management of the Analytical Development team. The position is further accountable for maintaining the Analytical laboratory in a highly optimized operational state and ensuring that laboratory quality, documentation and safety standards are adhered to. The individual will work closely with the Sr. Director and the Analytical Team on the development and optimization of analytical methods needed to support process development, in-process monitoring, drug substance and drug product release/stability testing, establishment of specifications, and writing of method qualification/validation protocols and reports to support client regulatory submission. The successful candidate will possess extensive analytical knowledge, highly refined communication skills and a demonstrated track record of leading highly functional analytical teams.

Responsibilities

Responsible for oversight, leadership and management of the Analytical team
Accountable for maintaining the Analytical laboratory in a highly optimized functional state and ensuring that laboratory quality and safety standards are rigorously adhered to
Responsible for maintaining, optimizing and expanding sample and knowledge management systems
Develops efficient, optimized processes to maximize work volume in a fast-paced client-based environment while balancing client requests with contracted scope of work
Accountable for maintaining a high-level of scientific rigor for all outputs of the team (methods, client updates, reports, data, etc)
Anticipates potential capacity issues and proactively communicates those issues to site leadership
Ensures the team activities remain within the recognized budget
Extensive experience with methods and instrumentation related to the following:, ELISA based assays (impurities and binding), cell based potency assays based on MOA, molecular biology, etc
Adheres to quality standards set by regulations and Abzena policies, procedures, and mission
Performs other duties as assigned

Qualifications

PhD in chemistry, biology, biochemistry, or related discipline, with a minimum of 8-10 years of relevant experience in the biopharmaceutical industry with 3-5 years of experience in a leadership role, or MS with 12-15+ years of relevant experience, including 3-5 years of leadership experience
Extensive knowledge of USP, ICH, EP, FDA, 21 CFR, and other guidance documents
People manager with ability to achieve results through teamwork and leadership of others, streamlined execution, and innovation
Strong verbal and written communication skills
Demonstrated ability to develop constructive and effective relationships with direct reports, colleagues, and senior management

$150,000 - $170,000 a year

FLSA: Exempt

Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.

Seniority level