Senior Manager, Biologics Downstream Development

Otsuka Pharmaceutical Co., Ltd; United States; À distance; USD 150 000 - 224 000; Plein temps

Avantages offerts par ce poste

Comprehensive benefits

401(k) match

Tuition reimbursement

Résumé du poste

Otsuka Pharmaceutical Co., Ltd is seeking a Senior Manager, Biologics Downstream Development to lead hands-on purification process development for biologics programs across development stages. You will guide chromatography, filtration, viral clearance, and UF/DF, interfacing with CDMOs and internal teams to ensure robust CQAs and CPPs.

The role requires strong scientific judgment, cross-functional collaboration, and the ability to independently drive complex CMC deliverables, including

Qualifications

• Experience in biologics downstream processing including purification and protein sciences.
• 5+ years in industry with leadership of technical staff.
• Strong knowledge of cGMP, ICH Q8/Q9/Q10 and data integrity.
• Experience with tech transfer and vendor management.
• Familiarity with DoE methods and data analysis (e.g., JMP).

Responsabilités

• 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.

Connaissances

Downstream processing

Leadership

cGMP knowledge

Design of Experiments

Data integrity

Formation

Bachelor's degree in Chemical Engineering/Biochemistry/Biotechnology

Master's degree (5+ years exp)

PhD (5+ years exp)

Outils

JMP

Description du poste

The Senior Manager, Biologics Downstream Development is an experienced technical individual contributor responsible for the execution of downstream process development activities for biologics programs across the development lifecycle. This role serves as a downstream 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 judgement, cross-functional collaboration, and the ability to independently drive complex CMC deliverables.

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 cGMP, 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.

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.

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.

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.

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.