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Althea Technologies, Inc.

Vice President, Drug Product

Althea Technologies, Inc. - San Diego, CA

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 Vice President of Drug Product

. As a member of the executive team the VP of Drug Product is responsible for developing partnerships and strategies to support the growth of Althea’s Drug Product business both of clinical and commercial campaigns. This role will interface extensively with clients and internal partners within Commercial, Quality, Regulatory, Project Management and Finance. The VP is accountable for the development of cost effective, environmentally safe, and state-of-the-art aseptic drug product manufacturing.

This is a unique and exciting opportunity to join the executive team at Althea. The successful candidate will be a strategic and innovative leader ready to leverage their experience within large commercial organizations.

Responsibilities

As a member of the Senior Management team works alongside other executive team members in developing and executing the company’s global strategic plans.

Maintains a broad, strategic view of the Company’s Drug Product business. Provides strategic direction to all related operations and functions including technical operations, process, and formulation. Monitor as necessary with a goal of constantly improving and or enhancing the capabilities of the Company.

Cultivates and maintains external relationships with partners, key customers and professional organizations.

Develops strategies to monitor and identify future market trends.

Accountable for product cost drivers, overall cost of ownership, risk management, compliance and ongoing cost improvement for all products.

Develops a strategic direction for technology improvement, new technology development and implementation.

Provides a clear vision of what the organization needs to do to ensure its future success.

Develops and monitors departmental budget including setting and meeting these targets.

Stays abreast of developments within the field of drug product manufacturing, analytical testing, process development, and changes in relevant regulatory requirements in the United States, Europe, and other parts of the world where Althea-produced products are shipped.

Develops and consistently meets production, quality, compliance, financial and EH&S goals and objectives.

Ensures collaboration and commitment between Operations and other departments (Compliance, Quality, Project Management, Commercial, Finance) in order to meet internal and external customer expectations.

Embodies Althea’s cultural values by aligning daily actions with department goals and company culture.

Builds the future of the organization through developing people, organizational capabilities, and the culture of Althea.

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 required, advanced degree preferred.

Minimum of fifteen (15) years of experience in biopharmaceutical industry.

Minimum of six (6) years of leadership experience.

Experience in a large commercial organization.

Strong knowledge of GMP compliance and quality.

Experience interfacing with the U.S. Food and Drug Administration (FDA) and, as appropriate, ex/US pharmaceutical regulatory agencies required.

Experience leading effectively across functional environments; driving decisions regarding overall manufacturing and supply chain priorities, allocation of human resources and finances, value of proposed projects, and effectiveness of manufacturing and supply chain performance.

Demonstrated record of leading an organization in the establishment and execution of an effective commercial manufacturing strategy.

Must possess a broad knowledge of aseptic biopharmaceutical manufacturing.

Demonstrated understanding of operational excellence initiatives and their value to a biopharmaceutical manufacturing organization.

Balance of strategic thinking and strong analytical skills with ability to execute.

Experience in problem solving, negotiations, presentation and collaborative team-building with direct and non-direct reports.

Supervisory Responsibilities

Directs and provides expert knowledge in the strategic function of Drug Product Manufacturing.

Develops short and long-term people and organizational strategy in alignment with Althea goals and direction.

Leads with impact & influence. Establishes credibility, effectively persuades and develops others, and achieves important objectives collaboratively.

Drives strategic change and promotes improvements within the organization.

Identifies, recruits, and retains top-notch talent.

Champions Althea’s culture and empowers employees to take responsibility for their jobs and goals.

Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.

Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, and regular interpersonal communication.

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.

8 days 9 hours ago

Althea Technologies, Inc.

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Location: San Diego, CA

Company Profile:
Althea Technologies, Inc., based in San Diego, CA, is focused on reducing the time, risk, and overall cost of our partner's drug development efforts. We apply immediate resources, unsurpassed scientific expertise, and a vast knowledge of regulatory affairs to facilitate the progression from drug discovery to clinical approval. Althea was founded in 1998 with the purpose of accelerating drug development by providing reliable, high quality services to the biotechnology and pharmaceutical industry. With our founders' well-known expertise in gene quantification and biopharmaceutical development, we began offering custom real-time qPCR assay services and plasmid DNA production. Today, Althea has established itself as a leading provider of these highly technical services. Our continued growth has enabled us to expand our service portfolio and more than double our manufacturing capacity.