Job Title

Responsibilities The Senior Manager, Biologics Drug Substance is responsible for mid-late stage biologic products development, including developing, optimizing and scaling up downstream or up stream bioprocesses for the commercial production of biologics, ensuring the robustness, scalability, and compliance of downstream or upstream operations. Job Description + Manage the technical aspects ofdownstream or upstream processoptimization, scale up andtechnology transfers to CDMOs, including documentation review, gap analysis, and risk assessment. + Support process characterization(PC)andprocess validation activities (PPQ) fordownstreamprocesses executed at CDMOs. + Oversee thedownstream manufacturing operations at CDMOs, including review of batch records, deviation investigations, and change controls. + Act as thetechnicalleadfortrouble shooting ofdownstream process deviations or performance issues at CDMOs, including determination of product or process impact, root-cause analysis, and corrective action identification. + Work cross functionally with Process Development, Manufacturing, Quality Assurance, Quality Control, Supply Chain, Project Management, Facilities, and other departments to effectively transfer andmaintainprocesses in the facility. Qualifications + Adegree in chemistry,biochemistry, chemicalengineering, or biologyand relevantpracticalexperience working inancGMP regulated environment. + Bacheloru2019sdegree with10+ years ofworkexperience,orMasteru2019sdegreewith7+years of workexperience, or PhD degree with 5+years of work experience. + For downstream:Experience withdownstream purification processdevelopment, processcharacterizationand validation + For upstream:Experience with cell line development, cell culture process development, cell culture processcharacterizationand validation. + Experienceofperformingprocessestechnical transfer and scale-up. + Knowledge of the drug development lifecycle, including preclinical and clinical stages, regulatory requirements, and quality standards. + Strong communication, and interpersonal skills, with the ability to influence and collaborate effectively and professionally with a wide range of individuals and organizations, both internal and external. + Ability to prioritize and manage multiple projects simultaneously, meet deadlines, and adapt to changing priorities in a dynamic environment + Ability to work independently and multi-task in a fast-moving organization. + Ability to travel up to 25%. 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 othersu2019 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 candidateu2019s 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; . 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 employer. All 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 disability. You 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 . 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 Otsukau2019s 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: , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (u201cOtsukau201d) 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 Otsukau2019s application portal without a valid written search agreement in place for the position will be considered Otsukau2019s 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.