Manager, Pre-Clinical Vector Manufacturing

Opportunity for Secondment to AskBio

Were pleased to share an exciting secondment opportunity at AskBio.

This role is available for a time period to be determined by leadership at both Bayer and AskBio. While most assignments range from one to two years the exact duration will be based on business needs and mutual agreement.

This secondment offers a unique chance to broaden your experience expand your knowledge and contribute meaningfully to AskBios mission: to advance gene therapy and change the lives of patients around the world.

If youre interested in exploring this opportunity we encourage you to:

• Speak with your direct manager to discuss your interest and alignment with your development goals.

• Apply directly using the link provided in the posting.

We look forward to seeing how our colleagues continue to grow and make an impact across the Bayer-AskBio partnership.

Our vision: Pioneering science to create transformative molecular medicines.

Our mission: Lead innovative science and drive clinical outcomes to transform peoples lives.

Our principles:

The Manager Upstream Pre-Clinical Manufacturing oversees the production of research and GLP-grade recombinant Adeno-associated virus (rAAV) vectors. Reporting to the Director of Pre-Clinical Manufacturing this role guides cross-functional teams in the successful delivery of vectors supporting early-stage gene therapy programsfrom proof-of-concept through GLP-tox material supply.

The Manager translates functional strategies into actionable operational processes optimizing resource allocation to meet aggressive timelines while ensuring high-quality data generation for capsid technology and therapeutic portfolios. Additionally this role establishes department-wide procedures to enhance efficiency and ensures the seamless execution of both small and large-scale manufacturing campaigns.

This position is on-site in RTPNC.

Job Responsibilities

• Manage upstream manufacturing activities determining resource requirements and scheduling to meet preclinical program timelines. Partner with management to forecast manufacturing strategies and timelines that support early-stage development through GLP-tox material supply.

• Lead risk-based process characterization and improvement initiatives to optimize product yield and scalability. Oversee the successful transfer of new processes into vector manufacturing performing risk assessments and identifying mitigations during transfer of new technologies.

• Mentor and manage a technical team of manufacturing personnel fostering a culture of technical excellence and accountability. Provide expertise in upstream operations (cell culture WAVE and stirred-tank bioreactors) and provide hands-on instruction or execution of manufacturing activities as required.

• Oversee the issuance review and approval of all manufacturing documentation including batch records investigations protocols reports and SOPs. Ensure high standards of data integrity are maintained through organized electronic laboratory notebooks and rigorous report review.

• Identify areas for process improvement lead root cause analysis for manufacturing failures and oversee the implementation of corrective actions. Develop and manage operational initiatives to improve business processes and department-wide efficiency.

• Ensure the laboratory is maintained in efficient working order by coordinating equipment maintenance/calibration raw material inventory and overseeing the strategic planning of supplies in partnership with lab operations and supply chain personnel.

• Track and evaluate manufacturing metrics and analytical results to determine potential sources of process variability and drive process updates to improve operational consistency.

• Act as a key technical contact for cross-functional stakeholders preparing internally reviewed reports and delivering technical presentations to internal and external leadership.

Minimum Requirements

• Bachelors Degree in Science or Engineering discipline (Chemical Engineering Biochemical Engineering Biotechnology Biology Chemistry Biochemistry or equivalent) with minimum of 8 years relevant industry experience or Masters with 6 years industry experience

• Experience in bioprocess manufacturing or laboratory research preferably in rAAV and/or recombinant protein/biomolecule bioprocess manufacturing and a desire to continue in a laboratory-focused role. Experience with process develop and/or supporting analytics is a plus.

• Knowledge and experience with upstream or downstream process operations such as cell culture centrifugation depth filtration tangential-flow filtration and/or chromatography with expertise in at least one functional area is required.

• Proven ability to manage and train a technical team and deliver results in a fast-paced team-oriented laboratory environment.

• Excellent written and verbal communication work planning data analysis and record keeping skills (with strong attention to detail) is required

• Demonstrated ability to generate results and innovative solutions independently and solicit buy-in from leadership

Preferred Education Experience and Skills

• Problem Solving & Analysis: Advanced troubleshooting skills for complex technical issues with the ability to lead root cause analysis and implement effective corrective actions

• Self-motivated and highly organized with a demonstrated ability to manage and re-prioritize group workloads to ensure departmental and project goals are met

• Experience working within a highly collaborative cross-functional environment with the ability to solicit buy-in from leadership and partner effectively with internal and external stakeholders.

• Familiarity with JMP Statistical Software and the ability to guide others in its application for data analysis trend analysis and process monitoring.

• Deep technical understanding of the gene therapy landscape specifically regarding rAAV vector manufacturing and upstream process operations.

• Advanced proficiency in the Microsoft Office suite (Word Excel PowerPoint Outlook) for data presentation and organizational communication. Familiarity with electronic notebook systems and scheduling tools a plus.

AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race color religion gender sexual orientation gender identity national origin age disability veteran status or any other protected status prohibited under Federal State or local laws. All employment decisions are based on valid jobrelated requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website you may request a reasonable accommodation to express interest in a specific opening by calling us at or sending us an email at .