Abzena
Associate Director, Analytical Development
Abzena, San Diego, California, United States, 92154
Associate Director, Analytical Development Join to apply for the
Associate Director, Analytical Development
role at
Abzena Associate Director, Analytical Development 1 day ago Be among the first 25 applicants Join to apply for the
Associate Director, Analytical Development
role at
Abzena Get AI-powered advice on this job and more exclusive features. With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Do you have the skills to fill this role Read the complete details below, and make your application today.
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
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionOther IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at Abzena by 2x Sign in to set job alerts for “Associate Director of Development” roles.Early Childhood Development Coordinator (Part-Time)Business Development Associate - Private EquityAssociate Scientist, Biology (Bioassays)Clinical Research Associate (15 month contract) San Diego, CA $85,000.00-$100,000.00 10 hours ago San Diego County, CA $80,000.00-$86,508.00 3 weeks ago Research Associate, Cell and Gene Therapy ResearchStaff Assistant II (Classified and Unclassified)Business Development Manager - ChemistryAssociate Director of Development: San Diego We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
Associate Director, Analytical Development
role at
Abzena Associate Director, Analytical Development 1 day ago Be among the first 25 applicants Join to apply for the
Associate Director, Analytical Development
role at
Abzena Get AI-powered advice on this job and more exclusive features. With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Do you have the skills to fill this role Read the complete details below, and make your application today.
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
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionOther IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at Abzena by 2x Sign in to set job alerts for “Associate Director of Development” roles.Early Childhood Development Coordinator (Part-Time)Business Development Associate - Private EquityAssociate Scientist, Biology (Bioassays)Clinical Research Associate (15 month contract) San Diego, CA $85,000.00-$100,000.00 10 hours ago San Diego County, CA $80,000.00-$86,508.00 3 weeks ago Research Associate, Cell and Gene Therapy ResearchStaff Assistant II (Classified and Unclassified)Business Development Manager - ChemistryAssociate Director of Development: San Diego We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr