Director, Analytical Outsourcing & Stability, Biologics Biopharmaceutical Development

Eisai US; United States; On-site; USD 203,000 - 266,000; Full time

Job summary

Eisai Inc. in the United States seeks a Director, Analytical Outsourcing & Stability to oversee product release and stability testing at US and international sites.

You will review analytical data, troubleshoot assays, and support early to late-stage programs with strong regulatory knowledge (FDA, EMEA, ICH, JP). The role requires 8+ years in biologics analytics, PhD preferred, with experience managing budgets and cross-functional teams.

Qualifications

• Ph.D. is highly preferred; graduate degree in biological sciences.
• 8+ years of analytical experience in biologics development with hands-on leadership.
• Strong knowledge of biologics manufacturing and analytical methods.
• Experience with cGMP, ICH, EMEA and JP guidelines across development stages.
• Prior contract manufacturing project management experience is desirable.
• Ability to manage budgets and financial decisions for multiple programs.

Responsibilities

• Oversee external testing lab collaborations and data interpretation.
• Troubleshoot assays and design future studies; manage assay transfer to CMO.
• Lead assay validation activities and coordinate with QA to ensure compliance.
• Manage project budgets, milestones and timelines across US and international sites.
• Communicate progress and risks to management and stakeholders.

Skills

Project management

Biologics knowledge

Analytical testing

Leadership experience

Interpersonal skills

Financial acumen

Travel willingness

Education

Ph.D. in Biological Sciences

Job description

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.

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. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation At Eisai Inc., human health care (hhc) is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides.

Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US and follow us on Twitter and LinkedIn.

All data that is entered should be in the correct case, please refrain from using all caps. For a better user experience, we recommend using the latest version of Chrome.