About this opportunity
Abzena lists this Associate Director, Analytical Development opportunity in san diego, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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.
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 level
Director
Employment type
Employment type
Full-time
Job function
Job function
Other
Industries
Pharmaceutical 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 Equity
Associate Scientist, Biology (Bioassays)
Clinical Research Associate (15 month contract)
San Diego, CA $85,000.00-$100, hours ago
San Diego County, CA $80,000.00-$86,508.00 3 weeks ago
Research Associate, Cell and Gene Therapy Research
Staff Assistant II (Classified and Unclassified)
Business Development Manager - Chemistry
Associate 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
Worksite address
san diego, CA, 92189, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.