1 Molecular Biology and Bioassays Director Job in Boston, MA

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Molecular Biology and Bioassays Director

KP Recruiting Group

Boston, MA | Full Time

$86k-109k (estimate)

4 Months Ago

Molecular Biology and Bioassays Director

$86k-109k (estimate)

Full Time | Business Services 4 Months Ago

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KP Recruiting Group is Hiring a Molecular Biology and Bioassays Director Near Boston, MA

KP Recruiting Group is a consulting firm that providesleadership and exceptional talent to some of the world’s leading companies.Headquartered in the Midwest, KP Recruiting Group has successfully completedcountless engagements across the United States. We represent clients in allindustries and all sizes. Our mission is to provide exceptional client andcandidate experiences in order to get the best possible results. On behalf ofour client, we are excited to present the following confidential role. We lookforward to hearing from you and discussing the opportunity!

The Role:

The GMU Analytical Development group has the overall responsibility to establish phase appropriate control strategies and to develop, qualify, and validate robust analytical methods to support release and characterization testing of different gene therapy candidates. The group supports the development and cGMP-compliant release and stability testing of clinical supplies.

We are looking for a skilled and highly motivated leader with broad expertise in gene therapy and cell biology method development to join the GMU Analytical Development group. The selected candidate will manage and develop a team of scientists and research associates who are tasked with performing potency and residuals method development and validation to enable rapid progression of various gene therapy candidates into the clinic.

Key responsibilities:

Establish and oversee a high performing team capable of supporting analytical development activities for gene therapy candidates with an emphasis on potency and residuals methods.
Evaluate and implement new technologies within the Analytical Development department, with a particular emphasis on state-of-the-art cell-based techniques (potency, residuals, cytokine expression, etc)
Maintain a cGMP-compliant laboratory environment and ensure departmental SOPs, internal company standards and applicable regulations are consistently followed
Write/review method protocols, assay qualification and validation plans/reports and ensure that the documents adhere to GxP requirements and ICH guidelines
Oversee in-process, release and stability testing as per the GxP and ICH guidelines
Write/review analytical sections of IND/IMPD filings to enable use of cell and gene therapy candidates in the clinic
Provide technical oversight and manage workload and staff assignments. Set priorities and objectives for staff to ensure timely completion of deliverables as per the project timelines
Develop team members by providing challenging assignments, performance assessments, and coaching
Provide guidance and mentorship to help junior staff with their career growth
Interface with third party contract laboratories as needed to manage project workload
Ensure compliance to regulatory and corporate safety standards

Requirements

Basic Qualifications:

Ph.D. in Biochemistry, Cell Biology/Molecular Biology, or a related discipline with a minimum of 10 years of relevant industry work experience or a Master’s or Bachelor’s degree with a minimum of 14 years of relevant industry experience

Proven expertise/experience in developing and qualifying/validating analytical methods to support product development and regulatory filings, preferably for cell and gene therapy products

Sound understanding of regulatory requirements for early-stage development of biologics including compendial requirements as well as requirements associated with the assessment of critical quality attributes, control strategies, stability, and comparability as outlined in ICH Guidelines and FDA guidance documents

Experience acting as an analytical team leader/representative on CMC teams

Excellent communication skills

Experience managing people in project-based or functional teams

Strong background in cell-based methods (e.g. potency, residuals, cytokine expression, etc), excellent instrument and method troubleshooting skills, as well as knowledge of various data analysis approaches

Working experience in a GMP environment and ability to adhere to all appropriate GMP standards (e.g. invalid result investigations, deviations, and CAPAs) will be considered an advantage

Preferred Qualifications:

Experience with qPCR, ddPCR, ELISA, Flow Cytometry, and/or related techniques will be desirable

General understanding of statistical principles supporting method performance and robustness assessments as well as Design of Experiment approaches used for method development/optimization