Director, Analytical R&D

Job Description

Job Description:

The GMP Operations branch of Biologics Analytical Research & Development (BAR&D) seeks a driven leader to advance and commercialize complex biotherapeutics.

The Director of Compliance, reporting to the Senior Director of GMP Operations, will oversee laboratory compliance across multiple sites, managing regulatory audits, internal quality and safety audits, quality notices, CAPA management as the business area representative, as well as release and stability programs. This position is in Rahway, NJ, and will foster an inclusive culture emphasizing quality and scientific rigor for a team of 8-10 scientists. Our BAR&D GMP Operations team validates analytical methods and performs release and stability testing for biologic therapies in clinical development, impacting global patient health and wellness.

Responsibilities include, but are not limited to, the following:

• Lead a team of scientists to conduct validations, technical transfers, and release and stability testing.

• Manage stability activities, including protocols, reevaluation dating, sample shipments, and execution of tests within specified windows for the North American GMP Operations team.

• Ensure inspection readiness and offer prompt support during regulatory, quality, and safety inspections.

• Address audit findings and identify trends to enhance laboratory compliance.

• Conduct laboratory investigations and collaborate with stakeholders to implement corrective or preventative actions.

• Develop and track internal compliance metrics and report the observed trends to senior management.

• Provide regulatory support by preparing or reviewing high-quality CMC sections for IND/CTA/NTAs.

• Timely communication and prompt delivery of analytical results to meet project milestones and regulatory requirements.

• Sets high standards, builds, and develops a high performing team.

• Collaborates with the leadership team to establish departmental goals and performance objectives, supports talent development initiatives, and proactively addresses performance-related issues. 

• Recruits, hires, and develops talent to advance the organization. 

Qualifications:

Education: 

• PhD in relevant scientific discipline with 8+ years’ experience; MS in relevant scientific discipline with 12+ years’ experience; BS in relevant scientific discipline with 16+ years’ experience

Required:

• Proven experience with GMP compliance in an analytical laboratory.

• Extensive experience in technical operations, including resource modeling and capacity planning.

• Expertise in analytical methodologies including SEC, IEX, CE, icIEF, qPCR, ELISA, cell-based potency, and compendial assays.

• Demonstrated proficiency in talent development through effective leadership and mentoring.

• Strong initiative, creativity, and innovation in problem-solving.

• Comprehensive knowledge of regulatory guidance and quality standards, with experience in authoring and reviewing regulatory submissions and responses, including biologics license applications, and engaging with Health Authorities.

• Substantial experience in technical problem-solving.

• Proficient in communicating scientific concepts, including writing and reviewing internal and external technical protocols and reports.

• Proven capability to achieve complex goals within stringent deadlines in a dynamic and evolving environment.

• Exceptional team player with excellent oral and written communication skills.

• Occasional travel required

Preferred:

• Proficiency with assay qualification, validation, and transfer to a GMP, GLP or regulated lab per ICH Q2 and USP<1033>.

• Experience with analytical testing for biologics, such as monoclonal antibodies (mAb), antibody-drug conjugates, and fusion proteins.

• Strong grasp of Critical Quality Attributes/QbD/DOE principles and statistical data analysis approaches.

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Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabiliti