Director, Quality Control & Stability
San Diego, CA 
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Posted 1 month ago
Job Description

Together, Let’s Make A Difference.

 

At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.

 

Every team member, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.

 

We believe our people are our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.

 

Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you.

  Summary:

Our Director will create and innovate at the strategic level, while providing experienced knowledge of the Quality Control (QC) and Stability functions. Being a leading CDMO, we work with a multi-product and multi-client business environment. We expect you to build effective partnerships with department heads to help drive the business toward achieving company objectives. This role will lead all aspects of Separation Sciences (HPLC, Capillary Electrophoresis), Wet Chemistry and Stability. An emphasis of responsibility will be centered around optimizing internal systems and procedures to reduce testing turn-around-times for release and stability samples as it relates to cycle times. In addition, you will independently manage client-specific product verification of all compendial methods. You will be responsible for representing the company during audits, visits, and technical calls and client visits.

  Responsibilities:
  • Establish and direct QC groups in QC support activities for GMP manufacture that will include method transfer, in-process testing, method validation, Drug Substance (DS) and Drug Product (DP) release testing, DS and DP stability studies, reference standard qualification, etc.
  • Provides scientific leadership in the generation of, all batch release data, final substance/product disposition, certificate of analysis generation and stability report review including trend [shelf life] analysis.
  • Develop departmental key performance indicators and analyze for opportunities to optimize department performance.
  • Ensures stability program meeting ICH requirements for tracking trending, assessment of lot pool ability [ANCOVA] and customer expiry dating evaluation for both the core business products as well as the high potency business products.
  • Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.
  • Develops short and long-term people and organizational strategy in alignment with company goals and direction.
  • Leads with impact & influence. Establishes credibility, effectively persuades and develops others, and achieves important objectives collaboratively.
  • Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
  Requirements:
  • Bachelor’s degree in a Life Sciences or equivalent required. Graduate degree (Masters or PhD) in a Life Science or Engineering preferred.
  • Minimum of ten (10) years relevant experience in Quality Control.
  • Experience in multi-client, multi-product services is required.
  • Minimum of five (5) years of leadership/supervisory experience.
  • Strong knowledge of cGMP regulations, building codes, safety and environmental requirements.
  • Proven track record and established leadership in biological and small molecule analytics applied to clinical drug development and GMP manufacture.
  • Proven ability to lead, empower and mentor scientific personnel and encourage teamwork.
  • Familiarity with JMP statistical analysis software is a plus.

 

We provide a Total Rewards package designed to make life better – both at work and at home.

  • Annual Bonus Opportunities for All Employees
  • 15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off
  • Annual Company Shutdown in December
  • Comprehensive Medical, Dental + Vision
  • 401K Company Match + Immediate Vesting
  • Backup Daycare and Eldercare
  • Monthly Employee Appreciation Events and Food Truck Fridays
  • Employee Discount Programs
  • Tuition Reimbursement
  • Casual Dress Code
  • Wellness Programs
  • Community Outreach Opportunities

 

If you meet the requirements above, and would like to apply for this position, please visit our website at www.ajibio-pharma.com and click on the "Careers" section. Please be sure to note where you saw our ad posting.

New hires will pass a background check and drug screen as a condition of employment.

We are an EOE dedicated to a diverse work force and Drug Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

 


"We are an EOE dedicated to a diverse work force and Drug Free work environment. Qualified M/F/D/V candidates are encouraged to apply."


 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
10 years
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