Senior Manager, Biologics Production - Downstream

Join Our Team as a Senior Manager for Biologics Production! As a critical leader in the mid to late stage development of biologic products, the Senior Manager for Biologics Production will drive the development, optimization, and scaling of drug production processes to ensure smooth transitions to commercial production—all while maintaining compliance standards. Key Responsibilities: Lead the technical optimization of downstream processes, including scale-up and the transfer of technology to Contract Development and Manufacturing Organizations (CDMOs). This involves detailed documentation reviews and comprehensive risk assessments. Support process characterization and validation efforts for downstream processes carried out at CDMOs. Oversee downstream manufacturing operations at CDMOs, including the review of batch records and investigating any deviations. Act as the technical lead in resolving downstream process deviations and performance issues, focusing on root-cause analysis and implementing corrective actions. Collaborate effectively across various functions, including Process Development, Manufacturing, Quality Assurance, and Quality Control, to ensure successful process transfers and maintenance. Qualifications: A degree in chemistry, biochemistry, chemical engineering, or biology along with relevant work experience in a cGMP regulated environment. Minimum of 10 years of experience with a Bachelor’s degree; 7 years with a Master's; or 5 years with a PhD. Demonstrated experience in downstream purification process development and validation. Knowledge of upstream processes including cell line development and culture process development is a plus. Proven expertise in process technical transfer and scale-up. Strong comprehension of the drug development lifecycle including regulatory and quality standards. Excellent communication and interpersonal skills to work effectively across various organizational levels. Adept at prioritizing tasks and managing multiple projects under tight deadlines in a fast-paced environment. Ability to work independently and adapt quickly to changing scenarios. Willingness to travel up to 25% as needed. Compensation: The salary for this position ranges from $150,034.00 to $224,250.00, with the possibility of additional incentives. Actual compensation is determined based on experience, skills, and internal comparisons. Benefits: We offer comprehensive medical, dental, and vision coverage, life insurance, both short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) plan, flexible time off, paid holidays, and a wide array of additional benefits. This job description outlines the role and responsibilities but is not an exhaustive list of tasks that may be assigned. Otsuka reserves the right to modify responsibilities as necessary. Otsuka is an equal opportunity employer. We encourage all qualified candidates to apply regardless of race, color, sex, or any other legally protected characteristic.

Created: 2026-03-10