Senior Director, Analytical Chemistry and Quality Control - San Diego, CA | Biospace
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Senior Director, Analytical Chemistry and Quality Control

Ajinomoto Althea, Inc.

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Location:
San Diego, CA
Posted Date:
6/23/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Analytical Chemistry, Chemistry, Director, QC, Quality, Quality Control,

Job Description

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 Senior Director, Analytical Chemistry and Quality Control. This position directs and provides expert knowledge in the day-to-day and strategic function of Analytical Chemistry and Quality Control (AD/QC) and is responsible for management of all AC/AD/QC activities in a multi-product, multi-client, CMO business environment. This position will be expected to work in a highly collaborative, cross functional team environment, and provide expert knowledge to the development, implementation, and maintenance of Analytical Chemistry and Quality Control systems and activities. This position is responsible for leading and managing the AD/QC Analytical Chemistry and AD/QC Chemistry departments.  

Responsibilities:
•   Creates and innovates at the strategic level, while managing diligent execution at the tactical level.
•   Establish and direct AD/QCAD/QC support activities for GMP manufacture that will include method development and transfer, in process testing, raw material testing, method validation, Drug Substance (DS) and Drug Product (DP) release testing, DS and DP stability studies, reference standard characterization, etc.
•   Collaborate with Process Development/Technical Transfer, Project Management, and Manufacturing Operations to devise practical AD/QC solutions.
•   Provides scientific leadership in the generation of validation reports, regulatory documents, investigations and risk assessments.
•   Develop departmental key performance indicators (KPI) and analyze for opportunities to optimize department performance.
•   Responsible for representing the company during audits, visits, and technical calls.
•   Responsible for representing AD/QC across multiple functional groups to include PMO, Business Processes, Manufacturing, and Sales.
•   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

Requirements:
•   Bachelor’s degree in a Life Sciences discipline or equivalent required, graduate degree (PhD) in a Life Science or Engineering discipline preferred.  
•   Minimum of twelve (12) years relevant experience in Analytical Chemistry and Quality Control. Experience in multi-client, multi-product CMO services preferred.
•   Minimum of eight (8) 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 build a team and develop team members.
•   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.

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.

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.