Senior Manager, Biologics Drug Substance; Upstream

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.

• Manage the technical aspects of downstream or upstream process optimization, scale up and technology transfers to CDMOs, including documentation review, gap analysis, and risk assessment.
• Support process characterization (PC) and process validation activities (PPQ) for downstream processes executed at CDMOs.
• Oversee the downstream manufacturing operations at CDMOs, including review of batch records, deviation investigations, and change controls.
• Act as the technical lead for troubleshooting of downstream 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 and maintain processes in the facility.

• A degree in chemistry, biochemistry, chemical engineering, or biology and relevant practical experience working in an cGMP regulated environment.
• Bachelor’s degree with 10+ years of work experience, or Master’s degree with 7+ years of work experience, or PhD degree with 5+ years of work experience.
• For downstream:
  Experience with downstream purification process development, process characterization and validation
• For upstream:
  Experience with cell line development, cell culture process development, cell culture process characterization and validation.
• Experience of performing process 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%.

• 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 $ - Maximum $, 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.

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This will be posted for a minimum of 5 business days.

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,…