Key Responsibilities
+ Execute and support downstream process development activities for assigned biologics programs under functional leadership.

+ Design, develop, optimize, and characterize purification processes including chromatography, filtration, viral clearance, and UF/DF. + Generate data and support for process understanding, CPPs and CQAs, and support development of control strategies. + Apply scientific approach to support development and optimization of purification process + Support technical interactions with CDMOs, ensuring alignment with defined development plans. + Support definition of downstream work plan and deliverables. + Review and approve CDMO-authored documents including development plans, protocols, reports, batch records, deviations, and investigations. + Support technical issue resolution with CDMOs, including troubleshooting, root-cause analysis, and implementation of corrective actions. + Support downstream process transfers into and out of CDMOs, including authoring and reviewing transfer documentation. + Author and contribute to downstream-related sections of regulatory filings (IND, IMPD, BLA, MAA). + Provide technical input to support downstream process for regulatory interactions, responses to agency questions, and inspections. + Ensure all downstream activities comply with applicable GMP, regulatory, and internal quality requirements.

Qualifications
+ •

Education:

Bachelor's degree in Chemical Engineering, Biochemistry, or Biotechnology with 10+ years of experience; OR Master's with 7+ years; OR PhD with 5+ years of relevant industry experience. +
Technical Experience:
Significant expertise in biologics downstream processing (purification, protein sciences). +
Leadership Experience:
At least 2-5 years of experience in supervising technical staff. +
Compliance:
Strong knowledge of c

GMP, ICH

Q8/Q9/Q10, and data integrity standards. +

Skills:
Experience in DoE (Design of Experiments) tools (e.g., JMP), tech transfer, and vendor management.
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://ah-prod.com/multi/videoplayer/player.html?v=6385356920112 .

Join Our Talent Community:
Stay connected with Otsuka by joining our Talent Community.

Tell us about your interests, and we'll notify you about future opportunities that align with your background.

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//community.hireez.com/cielo-otsuka/82cb3591

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 EEAccommodations@otsuka-us.com .

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. 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Senior Manager, Biologics Downstream Development