Director, Analytical Outsourcing & Stability, Biologics Biopharmaceutical Development

Eisai US; Exton, Northern (PA, KY); On-site; USD 203,000 - 266,000; Full time

Job summary

Eisai is seeking a Director of Analytical Outsourcing & Stability for Biologics Biopharmaceutical Development in Exton, PA. The role oversees analytical testing, stability programs, and tech transfers across US and international sites, while guiding projects from pre-IND through phase 3 and interacting with QA to ensure compliance with FDA, EMEA, ICH and JP guidelines.

The position requires a graduate degree in biological sciences (Ph.D.

Qualifications

• Graduate degree in biological sciences or related field; Ph.D. preferred.
• Minimum 8 years of analytical experience in biologics development.
• Strong knowledge of ICH, cGMP, EMEA and JP guidelines relevant to biologics development.

Responsibilities

• Manage external testing lab collaborations.
• Review and interpret analytical data.
• Troubleshoot analytical assays and design future studies.
• Manage assay tech transfer to CMO and assay validation activities.
• Review testing protocols and reports.
• Interact with QA and other departments to ensure compliance.
• Track finances and budgeting for multiple programs.

Skills

Leadership

Analytical experience

Regulatory knowledge

Project management

Budgeting knowledge

Education

Graduate degree in biological sciences

Ph.D. preferred

Job description

## Director, Analytical Outsourcing & Stability, Biologics Biopharmaceutical DevelopmentApply: Hybrid Work Arrangement: Pennsylvania, Exton: Full time: Posted Today: R4257At 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 willoversee 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.**Essential Functions*** Managing external testing lab collaborations* Review and interpretation of analytical data* Troubleshooting of analytical assays and design of future studies 25%* Managing assay tech transfer to CMO* Managing assay validation activities at CMO* Review testing protocols and reports* Interact with other departments within Exton* Tracking finances and accounting**Requirements** * Graduate level degree in biological sciences or related subject required; Ph.D. highly preferred with equivalent expertise required.* Must have a 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.* 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.* 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### **Eisai Salary Transparency Language:**The annual base salary range for the Director, Analytical Outsourcing & Stability, Biologics Biopharmaceutical Development is from :$202,800-$266,200### Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://careers.eisai.com/us/en/compensation-and-benefits.Certain other benefits may be available for this position, please discuss any questions with your recruiter.Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.