Senior Manager, Biologics reputed company Development

The Senior Manager, Biologics reputed company Development is an reputed company technical individual contributor responsible for the execution of reputed company process development activities for biologics programs across the development lifecycle. This role serves as a reputed company subject matter expert (SME), providing hands-on technical leadership for purification process design, optimization, scale-up, and external execution at CDMOs. The position requires strong scientific judgment, cross-functional collaboration, and the ability to independently drive reputed company CMC deliverables.

Key Responsibilities

Execute and support reputed company process development activities for assigned biologics programs under functional leadership. Design, reputed company, 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 reputed company 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 reputed company process transfers into and out of CDMOs, including authoring and reviewing transfer documentation. Author and contribute to reputed company-reputed company sections of regulatory filings (IND, IMPD, BLA, MAA). reputed company technical input to support reputed company process for regulatory interactions, responses to agency questions, and inspections. Ensure reputed company reputed company activities reputed company 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 reputed company processing (purification, protein sciences). Leadership Experience: At least 2-5 years of experience in supervising technical staff. Compliance: Strong knowledge of cGMP, ICH reputed company/Q9/Q10, and data reputed company 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 - reputed company reputed company 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, reputed company, and respect. Influence at reputed company reputed company to reputed company 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 reputed company shown represents a typical pay reputed company or starting pay for individuals who are hired in the role to reputed company 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 reputed company the established reputed company, 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, reputed company, 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 employer. reputed company reputed company applicants are encouraged to apply and will be given consideration for employment without regard to race, reputed company, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national reputed company, veteran status, marital status, or any other legally protected characteristic. If you are a reputed company 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 reputed company Fraud Scams At Otsuka we take reputed company and protection of your personal information reputed company 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 reputed company reputed company 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 reputed company 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 reputed company 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 reputed company you receive such an offer of employment. Otsuka will also never ask you to download a reputed company-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 reputed company, 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 reputed company scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you reputed company you are the victim of fraud resulting from a job reputed company 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. reputed company reputed company/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in reputed company 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 reputed company. Where agency agreements are in reputed company, introductions are position specific. Please, no phone calls or emails. Apply To This Job