Director, Analytical Outsourcing & Stability, Biologics Biopharmaceutical Development

Eisai US•Exton, PA

9d•$202,800 - $266,200

About The Position

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Director, Analytical Outsourcing & Stability will oversee product release and stability testing at sites in the US and internationally. This position will also serve as a scientific and technical resource to support several early to late-stage manufacturing programs. This position will be responsible for the review and interpretation of analytical testing data as well as protocols and reports, with an emphasis on scientific validity and adherence to FDA, EMEA, ICH and JP guidelines. This position will also spend a significant amount of their time troubleshooting assays, designing future studies, overseeing assay validation and interacting with QA to determine product stability and shelf life. Since these programs are for products from pre-IND through phase 3, knowledge of the regulatory requirements at each stage of clinical development is essential. This position will have a direct impact on the success of the company by managing the analytical testing for several products, as well as interfacing with internal and external clients, suppliers and contractors. This position will ensure that these projects remain on schedule and within budget, as well as identify major milestones and critical steps needed for the success of the projects and the development programs they support. This position will be responsible for communicating with team members and management about progress, potential impediments and solutions. Other projects and responsibilities may be added at the company's discretion.

Requirements

Graduate level degree in biological sciences or related subject required; Ph.D. highly preferred with equivalent expertise required.
Minimum of 8 years of relevant analytical experience with biologics development, several of which must be in a management position.
Strong knowledge of biologics manufacturing and analytical methodology as well as ICH, cGMP, EMEA and JP guidelines as they pertain to the development/manufacturing of monoclonal antibody-based, ADC, bispecific and fusion protein-based therapies required.
An understanding of project accounting and financial concepts is also required since this individual will participate in the budgeting, tracking and financial decision-making for multiple drug development programs.
A hands-on, proactive stance is essential with willingness and ability to assist all team members to achieve project and corporate goals.
Excellent interpersonal skills are mandatory, in addition to analytical problem solving, the ability to set priorities and achieve goals; strategic thinking, energy, enthusiasm and an entrepreneurial mindset.
The ability and willingness to travel (domestic and international) approximately 20% of the time is required.

Nice To Haves

Prior contract manufacturing project management experience is highly preferred.
Prior experience with biologics development from pre-IND through phase 3 or commercial production is highly desired.

Responsibilities

Oversee product release and stability testing at sites in the US and internationally.
Serve as a scientific and technical resource to support several early to late-stage manufacturing programs.
Review and interpret analytical testing data, protocols, and reports, with an emphasis on scientific validity and adherence to FDA, EMEA, ICH and JP guidelines.
Troubleshoot assays, design future studies, oversee assay validation, and interact with QA to determine product stability and shelf life.
Manage external testing lab collaborations.
Manage assay tech transfer to CMO.
Manage assay validation activities at CMO.
Review testing protocols and reports.
Interact with other departments within Exton.
Track finances and accounting.
Communicate with team members and management about progress, potential impediments, and solutions.