Careers – Quality Role

NJ Bio Inc is a growing chemistry and biotech CRO with laboratories located in Princeton, NJ and Bristol, PA. NJ Bio offers a competitive salary, great benefits, and significant growth opportunities within the organization.

NJ Bio is constantly expanding its team and is looking for dedicated and talented individuals.  We currently have the following job openings in the Quality Department:

Urgently hiring for a R&D Quality Assurance Director:

We are looking for a R & D Quality Assurance Director to support establishment of a new cGMP manufacturing facility for clinical supplies (Phase 1 and 2 studies) for pharmaceutical and biotech clients in the ADC and small molecules space. This role has great potential to grow into a senior leadership role in the organization.

Job Responsibilities

• Participate in the design and planning for R&D cGMP manufacturing suites.
• Establish phase appropriate quality systems to support phase 1 and phase 2 clinical phase manufacturing of small molecule APIs, antibody-drug conjugate (ADC) drug substances, and ADC drug product.
• Ensure that all applicable phase appropriate quality guidelines and regulations are followed, as appropriate for preclinical, tox, and phase 1 and 2 clinical manufacturing.
• Manage QA professionals assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs, goal setting, and performance management in accordance with the company’s HR policies, to ensure all QA professionals are aligned and motivated towards achieving the company’s goals, values, and culture by promoting their personal and professional development while maximizing productivity.
• Oversee all QA organization in the Site under his/her responsibility to assure that all applicable procedures, established objectives are followed and achieved
• Be the senior management representative in meetings with clients, vendors, and regulatory agencies.
• Review and approve critical quality documents such as batch records, CofAs for release of materials & stability samples in GMP.
• Oversee administration of GMP and non-GMP documents and training in the electronic document management system.
• Train all employees in cGMPs.
• Execute internal audits and audits to vendors and external clients according to the established plans, needs and the criticality of the audits; provide overviews of audit findings for presentation to management as required and respond to the client audits.
• Manage the CAPA, change control, deviation, and risk assessment programs.
• Work closely with GMP Manufacturing, Quality Control, Facilities, and Analytical leadership to ensure that manufacturing, laboratory, facilities, analytical activities, and materials operations are conducted in compliance with current Good Manufacturing Practices (cGMP).
• Stay abreast of regulatory and compliance requirements to ensure the company remains compliant with all applicable laws and guidelines.
• Oversee environmental monitoring in GMP manufacturing facility.
• Responsible for final disposition of raw materials, intermediates, API/DS batches, and DP batches.
• Create an environment where continuous improvement is part of the teams’ activities and drive for the simplification of procedures and daily tasks.
• Create a culture of safety, quality, and compliance. Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice

Skills

• Have experience to lead a R&D Quality Assurance department.
• Experience with manufacturing, laboratory, facilities, and materials operations in compliance with current Good Manufacturing Practices (cGMP) and global regulatory authority requirements for early phase R&D APIs, ADCs, etc.
• Must possess excellent oral and written communication skills.

Education and Experience Requirements

• BS, MS, or PhD degree in chemistry, biology, biochemistry, microbiology, or related discipline.
• 5+ years of experience in a R&D GMP manufacturing or CRO setting in QA department, preferably in ADCs, payloads, linkers, APIs, or intermediates of APIs.