Vacancy expired!
- Developing, qualifying and transfer of product-specific assays to be used for release testing, stability testing, and extended characterization.
- Providing analytical support to Process Development (PD) activities by ensuring consistent and timely execution of standardized product characterization assays, including data review, storage, and trending.
- Integrating new program products into Client's analytical platforms, to ensure timely progress of technology transfers and regulatory submissions.
- Providing late stage analytical development support to Quality and Regulatory efforts, during investigations, risk assessment, regulatory filings and validation activities, to ensure the maintenance and continuous improvement of the analytical packages for each program, in accordance with appropriate legislation and following the highest quality standards.
- Lead a team of scientists and technicians focused on the GMP support of late stage analytical methods for gene therapy applications, including assay troubleshooting, QC team validation issues, investigations, laboratory testing, and documentation
- Act as subject matter expert for analytical methods, with a high level of understanding of assay principles, and an ability to critically analyze and present complex data sets
- Be the first point of contact for GMP support (QC and regulatory) for assays in stage II and III on analytical lifecycle (post qualification and transfer)
- Drive alignment of platform assays across AD sites with QC assays during revisions and updates of platforms driven within QC or AD
- Ensure on time, complete delivery of GMP support activities according to project specific needs, and according to platform renovation plans. Escalate Timeline/Resources constrains that cannot be resolved at the team level
- Aligns goals of the team with overall project timelines. Identifies and escalates technical and delivery risks, removes obstacles to successful delivery. Working with the other team leads and project management, proactively manages changes to scope and timeline effectively.
- Prepares technical summaries appropriate for management review. Reviews team presentations, protocols, and reports. Provides constructive feedback to address gaps
- Develop and mentor direct reports through challenging assignments and constructive feedback.
- Creates and fosters an environment that increases employee commitment. Holds team members accountable to deliver results within an agreed governance structure to achieve the company goals.
- Supervises team activity in the labs to ensure that everyone is fully capable, operationally efficient, and safe. Maintains constant emphasis on safety and ensures a safe working environment for self and others.
- A Life Sciences Ph.D. + 6 years' or M.S. + 10 years' relevant post-graduate experience, including intensive experience in biotech industry, is required
- At least 2 years' experience leading scientists and/or technicians as direct reports
- Broad hands-on experience in analytical development of biologics is required, experience in viral vaccines or gene therapy is a plus
- Experience with method transfer to GMP labs, assay troubleshooting and process/product investigations are required
- Experience of assay characterization, qualification, and validation with EMA/FDA regulations, ICH guidelines, GMP and quality systems is preferred
- Strong knowledge and understanding of cell based (potency or infectivity), molecular (RT-PCR, qPCR or ddPCR, NGS a plus), and Biochemistry (e.g. HPLC, ELISA) assays.
- Ability to adapt to, communicate, and support re-prioritization of activities and goals in a fast-paced environment
- Excellent problem-solving and stakeholder management capabilities. Structured and proactive working attitude, strong work ethic, drives results.
- Proven leader and motivating team player, with excellent organizational skills and the ability to communicate complex technical content in a clear and concise way
- Analytical Thinking and Problem Solving: Able to identify and separate out the key components of problems and situations. Able to manipulate and interpret information from a range of sources, to spot patterns and trends in information and to deduce cause and effect.
- Planning & Organizing: Able to plan own and other's work to achieve results in a timely way while ensuring high quality output. Communication with others to align planning of multiple complex activities simultaneously, planning and scheduling activities with technicians within the team. Sees priorities, plans the efficient use of resources, and monitors progress against objectives.
- Accountability and ownership: signals problems, recognizes important information, traces possible causes of problems, thinks about and implements new working methods or new applications, brings forward original solutions for problems related to the team
- Collaboration: Actively participates in interdisciplinary team. Encourages co-operation. Aware of the needs of others and responds flexibly. Shares information and supports other team members. Prioritizes team goals over individual goals.
- Strong written and spoken communication skills: including document writing and oral presentations. Able to critically analyze and present complex data sets in a clear and organized manner.
Vacancy expired!