Otsuka Pharmaceutical Companies (U.S.)

Senior Manager, Biologics Analytical Development (Bioassay)

Otsuka Pharmaceutical Companies (U.S.)  •  $150k - $224k/yr  •  United States (Remote)  •  9 hours ago
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Job Description

The Sr. Manager, Biologics Analytical Development (Bioassay) will execute and support the development, qualification, and lifecycle management of bioassays supporting biologics programs from early development through late-stage clinical and commercial manufacturing. This role provides scientific technical oversight n for cell-based and ligand-binding assays to support product characterization, potency determination, comparability, and regulatory submissions.

Key Responsibilities

  • Execute and support development, optimization, qualification, and validation of bioassays, including:
    • Cell-based potency assays
    • Binding and functional bioassays (e.g., ELISA, MSD, SPR, flow cytometry)
  • Support development of assay strategies aligned with regulatory expectations for biologics.
  • Manage assay robustness, transfer, and comparability across product lifecycle stages.
  • Serve as subject matter expert (SME) resource supporting bioassays activities on cross-functional project teams.
  • Provide technical input to CMC, Regulatory, Quality, and Process Development functions.
  • Contribute to assay strategies for IND, BLA/MAA, and post-approval changes.
  • Ensure high quality and timely delivery of analytical , compliance, and continuous improvement.
  • Author, review, and approve technical documents including development reports, protocols, validation reports, and regulatory filings.
  • Provide analytical support and technical input for regulatory submissions and inspections.
  • Ensure activities are conducted in compliance with GLP/GMP and data integrity standards.
  • Oversee method transfer to internal QC or external contract testing laboratories (CDMOs/CROs).
  • Coordinate and oversee outsourced bioassay activities and ensure alignment with project timelines and quality expectations.
  • Evaluate assay technologies and recommend improvements to enhance assay performance and efficiency.

Qualifications & Experience

Education

  • PhD in Biology, Biochemistry, Immunology, Bioengineering, or a related discipline

Experience

  • 8–10+ years of experience in analytical development for biologics, with strong emphasis on bioassay development
  • Demonstrated leadership experience managing scientific teams
  • Experience supporting biologics development activities and contributing to regulatory submissions Strong hands-on and theoretical knowledge of:
    • Cell-based assays (reporter gene, proliferation, cytotoxicity, signaling assays)
    • Ligand-binding assays (ELISA, MSD, ECL platforms)
    • Potency assay design, qualification, and validation
  • Solid understanding of ICH, USP, FDA, and EMA expectations for bioassays

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Application Deadline This will be posted for a minimum of 5 business days.

Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka

Disclaimer:

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employerAll qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disabilityYou can request reasonable accommodations by contacting Accommodation Request

Statement Regarding Job Recruiting Fraud Scams

At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External

Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities.

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Otsuka Pharmaceutical Companies (U.S.)

About Otsuka Pharmaceutical Companies (U.S.)

There are two Otsuka pharmaceutical industry companies in the U.S.:

Otsuka America Pharmaceutical, Inc. (OAPI) successfully commercializes Otsuka-discovered and in-licensed products in North America.

Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) clinically develops and registers innovative healthcare products on a global basis.

Industry
Chemicals & Materials
Company Size
1,001-5,000 employees
Headquarters
Princeton, NJ
Year Founded
Unknown
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