Director – Quality Control & Stability

Location
92121, San Diego
Posted
Jun 22, 2018
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time

Let’s Make Things Happen!

 

Ajinomoto Althea, Inc. is a fully integrated contract development and manufacturing organization providing clinical drug process development and manufacturing services to global biotechnology and pharmaceutical companies.

 

Althea is a leading expert in aseptic filling of drug product in vials and syringes, and our focused expertise and capabilities make us one of the industry’s top leaders for cGMP microbial fermentation of recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, Althea offers comprehensive development services including: upstream and downstream process development, complex formulations, lyophilization cycle, analytical development, product release and ICH-compliant stability testing.

 

Now is an exciting time to join Althea. We have talented people working together to help our clients advance their innovative product pipelines. We believe that people are our greatest asset and we are committed to providing our employees with an environment that fosters personal and professional growth.

 

Our work atmosphere is fast paced, stimulating and customer focused. Employees take pride in knowing our efforts are helping countless patients for years to come.

 

Althea is currently seeking a Director – Quality Control & Stability responsible for oversight of all core QC projects and activities in a multi-product, multi-client, CDMO business environment, as related to batch release, client method induction and stability. This position will be expected to work in a highly collaborative, matrix management environment, and provide expert knowledge to the development, implementation, and maintenance of quality control systems and activities. This position is responsible for the areas of Separation Sciences (HPLC, Capillary Electrophoresis), Wet Chemistry and Stability.

 

An emphasis will be placed on optimizing internal systems and procedures to reduce testing turn-around-times for release and stability samples as it relates to cycle times.

 

This position will partner with Analytical Chemistry to ensure smooth transfer of methods into QC, including resource management as part of the methods induction team which will include method transfer, qualification and/or validation. This position will independently manage client specific product verification of all compendial methods.

 

 

Responsibilities:

  • Creates and innovates at the strategic level, while managing diligent execution at the tactical level. Includes identifying and sponsoring operational excellence and continuous improvement projects to collaborate on with the Operational Excellence department.
  • 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.
  • Collaborate with Analytical Technologies, Project Management, and Manufacturing Operations to implement practical solutions and control systems to ensure the highest level of product quality.
  • 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 (KPI) and analyze for opportunities to optimize department performance.
  • Ensures stability program meeting ICH requirements for tracking trending, assessment of lot poolability [ANCOVA] and customer expiry dating evaluation for both the core business products as well as the high potency business products. 
  • Responsible for representing the company during audits, visits, and technical calls and client visits.
  • Responsible for representing QC and Stability across multiple functional groups that include Client Services, Project Management Organization (PMO), Business Processes, Drug Substance/Drug Product Manufacturing, and Sales. Assesses cross laboratory capacity/capability to provide analytical service pricing for quotes for prospective clients.
  • Builds effective partnerships with department heads to help drive the business toward achieving company objectives.
  • Embodies Althea’s cultural values and aligns daily actions with department goals and company culture.
  • Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

Requirements:

  • Bachelor’s degree in a Life Sciences discipline or equivalent required, graduate degree (Masters or PhD) in a Life Science or Engineering discipline preferred. 
  • Minimum of ten (10) years relevant experience in Quality Control. Experience in multi-client, multi-product CDMO services preferred.
  • 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.
  • Demonstrated ability to manage, motivate and mentor scientific personnel and encourage teamwork.
  • Detail oriented and strong written and verbal communication skills.
  • Advanced knowledge of Microsoft Office applications.
  • Familiarity with JMP statistical analysis software is a plus.

Leadership Responsibilities

  • Champions Althea’s culture and empower employees to take responsibility for their jobs and goals.
  • Engages employees by creating a climate in which they want to do their best.
  • Sets performance standards and encourages employee engagement through delegation, continuous feedback, goal setting and performance development planning.
  • Maintains employee work schedules
  • Identifies recruits and retains top-notch talent.
  • Coaches, mentors and develops staff, including overseeing new employee onboarding and providing career development planning and training opportunities.
  • Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, and regular interpersonal communication
  • Manages for results by setting and communicating goals and metrics.

 

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

 

Successful Candidate must 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.

 

Qualified M/F/D/V candidates are encouraged to apply.