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Sr. Director / Vice President, Technical Operations

Company: Actym Therapeutics, Inc.
Location: Berkeley
Posted on: January 13, 2022

Job Description:

The Company

Actym Therapeutics, Inc., based in Berkeley, CA, is an immunotherapy company focused on the discovery and development of novel therapies that are intended to transform the treatment of cancer. - -Patients burdened with metastatic disease desperately need new and effective treatment options. - -Actym's STACT technology platform is designed to harness the body's natural immune system to modify the tumor microenvironment. Actym's platform technology allows for the delivery of multiplexed immunological payloads to the tumor microenvironment (TME) after IV dosing, in a single therapeutic composition. This includes the targeting of immune pathways that are intractable using conventional small molecule or antibody-based therapeutics. -Actym recently completed a significant venture financing and is backed by top tier investors.

Our people are our greatest asset. They bring scientific talents in molecular biology, cancer immunology, genomic engineering, microbiology, and pharmacology to make the future happen now.

Short Overview of the Role

As a strategic partner to the Chief Development Officer, you will create, lead and drive our manufacturing and process development for our microbial-based cell therapy products.
You will thrive in a dynamic, fast-paced and team-oriented startup environment. In addition, you must possess a strong development-focused, resourcefulness, innovator's mindset with a desire to bring therapeutic benefit to cancer patients.

Team and Reporting Relationship

The Sr. Director/Vice President, Technical Operations will report into our Chief Development Officer and manage a team of scientists focused on product development of Actym's therapies. - -This candidate will partner closely with current and future members of the executive leadership team, and members of the Scientific Advisory Board.

Actym's Core Values

Commitment: - We are committed to bringing life-saving drugs to patients with cancer.
Accountability: We are accountable to each other and accept responsibility for our actions.
Quality: - We are committed to the highest level of quality in our experiments, analyses, and communications with each other.
Respectfulness. - We are respectful of each other and the diverse backgrounds that we bring to the team.
Decision making. - Attuned to opportunity, we make intelligent decisions, adapting to create the best outcomes. -We are decisive and undaunted by failure. -We accept what doesn't work, learn from it, and get on to what does.
Collaboration. - We achieve our goals together, inspiring, sharing, and creating as a team.
We do the right thing.

Responsibilities

Develop and lead the implementation of comprehensive strategies to manufacture therapeutic product, and own all aspects of process / analytical development, manufacturing
Lead all elements of technical operations, process development, manufacturing, and supply chain resources to develop a scalable, cGMP-compliant process to manufacture microbial-based cell therapy products
Oversee the selection and management of network of Contract Development and Manufacturing Organizations (CDMOs) and Contract Research Organization (CROs)
Person in Plant representing the Company for major manufacturing campaigns
Drive accountability by creating and articulating a clear plan of action aligned to the corporate and program objectives, guide daily activities of the team, and provide ongoing feedback at an individual and team level
Collaborate closely with other functions -to ensure successful program development; encourage cross-functional collaboration with peers to overcome challenges
Responsible for developing and managing timelines, budgets and ensuring development and tech transfer of processes occur in a timely manner
Responsible for establishing the necessary SOPs, batch records, reports, and drafting relevant IND sections and other regulatory documents for clinical translation and development of the cell therapy platforms
Organize, communicate, and present complex data sets to senior management and key stakeholders

Requirements
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Ph.D. or M.S. in Microbiology, Biochemistry or Chemical Engineering, 10+ years industry experience is required
10+ years of experience in academia, biotechnology or pharma industry with a primary focus on the development, manufacture, distribution and delivery of microbial cell-based therapy products
10+ years of increasing responsibility in managing and leading a team of process development engineers and manufacturing teams
Experience with the set-up, technology transfer and execution of manufacturing processes and controls internally or at CMOs
Experience preparing documentation for regulatory filings with US and EU regulatory agencies
Demonstrated technical and strategic leadership and problem-solving skills
Ability to work independently and as part of a team with exceptional resourcefulness and ability to collaborate and lead
Experience presenting complex concepts to all levels of the organization, with proven ability to clearly articulate a point of view and recommendation
Ability to lead a team and mentor individuals to achieve organization, team and individual objectives while adhering to the company values
Expertise influencing across functions and teams to achieve organizational objectives
Expertise in staffing, budgeting and expense management
Proven project management capability with a track record of meeting timelines is required
Excellent written and oral communication skills to influence effectively across the organization and with CDMOs

Keywords: Actym Therapeutics, Inc., Berkeley , Sr. Director / Vice President, Technical Operations, Executive , Berkeley, California

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