Sr Manager, Product Analytical Development Gmp Support, Gene Therapy at Day & Zimmermann in Lexington, MA
The Sr. Manger for GMP Support, will be part of the Product Analytical Development (PAD) group supporting the late stage development of AAV-based gene therapy products. The Team Lead will focus on assay technical support and troubleshooting, and act as the first point of contact for GMP support (QC, QA & regulatory) for late stage activities. They will be a PAD representative to CMC and project teams post IND/IMPD. These activities will be highly cross-functional, requiring strong communication skills. Place in the Organization The GMP Support team is part of the Lexington PAD group in Lexington, embedded within the PAD Global organization, part of Analytical Development department, which also consists of the Drug Product Development (DPD) group. Sr Manager GMP Analytical Support will be a contributor to the activities of PAD group, leading the GMP support team. The core focuses of the GMP Support team are:
Providing late stage analytical development support to Quality and Regulatory efforts, during investigations and risk assessment by leveraging PAD SME network Support QC during validation activities, by providing scientific and technical review of validation strategy, protocol and reports. Ensure execution of troubleshooting and continuous improvement activities relevant to PAD within the context of the late stage analytical methods lifecycle. Support regulatory filings post IND/IMPD in accordance with appropriate legislation and following the highest quality standards The Sr. Manager reports to Product Analytical Development Director in Lexington. Key result areas (major duties, accountabilities, and responsibilities) Lead a team of scientists and technicians focused on the GMP support of late stage analytical methods for gene therapy 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) Represent AD in OOS, DEV, Investigations, MRB, SRB and act as a link between Quality and Regulatory teams and PAD groups for PAD deliverables Act as a subject matter expert for QC assays or identify and involve relevant SME as needed during OOS, DEV, Investigations Facilitate new assay introductions in QC from GMP compliance stand point (act as a GMP advocate within AD) and lead alignment of AD methods with QC Support QC validation activities assays in coordination with relevant SME, QA and QC Ensure review of validation protocols and reports from a technical and scientific stand point Continuous improvement of the processes underlining GMP support activities (regulatory filings support, OOS/Deviations/Change Control support, experimental design, execution and reporting) Plan required resources to deliver GMP support activities and provide input for budgeting Align goals of the team with overall project timelines. Identify and escalate technical and delivery risks, remove obstacles to successful delivery. Working with the other team leads and project management, proactively manage changes to scope and timeline effectively. Prepare technical summaries appropriate for management review. Review team presentations, protocols, and reports. Provide constructive feedback to address gaps Develop and mentor direct reports through challenging assignments and constructive feedback. Qualifications & Skills A Life Sciences Ph.D.
8 years' or M.S.
10 years' relevant post-graduate experience, including intensive experience in biotech industry, is required At least 3-5 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 and validation to/in GMP labs, assay troubleshooting, and process/product investigations is required Experience of assay characterization, qualification, and validation with EMA/FDA regulations, ICH guidelines, GMP and quality systems is required 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 Core competencies 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.
Salary Range:
$150K -- $200K
Minimum Qualification
Brand Marketing & ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
Providing late stage analytical development support to Quality and Regulatory efforts, during investigations and risk assessment by leveraging PAD SME network Support QC during validation activities, by providing scientific and technical review of validation strategy, protocol and reports. Ensure execution of troubleshooting and continuous improvement activities relevant to PAD within the context of the late stage analytical methods lifecycle. Support regulatory filings post IND/IMPD in accordance with appropriate legislation and following the highest quality standards The Sr. Manager reports to Product Analytical Development Director in Lexington. Key result areas (major duties, accountabilities, and responsibilities) Lead a team of scientists and technicians focused on the GMP support of late stage analytical methods for gene therapy 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) Represent AD in OOS, DEV, Investigations, MRB, SRB and act as a link between Quality and Regulatory teams and PAD groups for PAD deliverables Act as a subject matter expert for QC assays or identify and involve relevant SME as needed during OOS, DEV, Investigations Facilitate new assay introductions in QC from GMP compliance stand point (act as a GMP advocate within AD) and lead alignment of AD methods with QC Support QC validation activities assays in coordination with relevant SME, QA and QC Ensure review of validation protocols and reports from a technical and scientific stand point Continuous improvement of the processes underlining GMP support activities (regulatory filings support, OOS/Deviations/Change Control support, experimental design, execution and reporting) Plan required resources to deliver GMP support activities and provide input for budgeting Align goals of the team with overall project timelines. Identify and escalate technical and delivery risks, remove obstacles to successful delivery. Working with the other team leads and project management, proactively manage changes to scope and timeline effectively. Prepare technical summaries appropriate for management review. Review team presentations, protocols, and reports. Provide constructive feedback to address gaps Develop and mentor direct reports through challenging assignments and constructive feedback. Qualifications & Skills A Life Sciences Ph.D.
8 years' or M.S.
10 years' relevant post-graduate experience, including intensive experience in biotech industry, is required At least 3-5 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 and validation to/in GMP labs, assay troubleshooting, and process/product investigations is required Experience of assay characterization, qualification, and validation with EMA/FDA regulations, ICH guidelines, GMP and quality systems is required 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 Core competencies 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.
Salary Range:
$150K -- $200K
Minimum Qualification
Brand Marketing & ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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