Head of Manufacturing – AD/Director Small molecules

Head of Manufacturing – AD/Director Small molecules

Job Summary

The Head of Manufacturing will be mainly responsible for managing the manufacturing of multiple pharmaceutical products for small molecules and biological therapy entities and drug substances such as Antibody Drug Conjugates (ADCs).

Job Responsibilities

• Build, develop, and lead a department that has the capability to manufacture multiple active pharmaceutical products (API) including high-potent APIs (HPAPI), mRNAs, and drug substances (DS) such as Antibody Drug Conjugates (ADCs) following GMP standards.
• Coordinate activities with functional groups such as facilities, process engineering (manufacturing sciences and technology (MSAT), Technical Services (qualification/validation & Maintenance), and materials management that support the manufacturing of GMP materials.
• Oversee the department’s finalization of manufacturing campaigns.
• Develop short- and long-term technical objectives for the organization that cover manufacturing.
• Lead and manage NJ Bio’s manufacturing efforts, collaborating closely with appropriate stakeholders to ensure alignment with the company’s timelines.
• Establish project/program milestones and timelines to drive programs through solid leadership, empowerment, and accountability, ensuring that goals are met on time and within budget.
• Work with senior leadership to evaluate customers/clients and recommend decision on manufacturing capability.
• Provide guidance on manufacturing matters to customers/clients/partners/collaborators.
• Represent the company, addressing aspects of the company’s manufacturing capabilities.
• Partner with Quality colleagues and implements appropriate QA/QC process and controls; has a QA/QC first mindset.
• Partner with Process R&D colleagues to ensure technical transfer of manufacturing process from lab/pilot scale to GMP.
• Ensure regulatory inspection preparedness planning for customer/client, investor and regulatory agency visits and inspections while understanding and implementing processes, controls, and methods that align with global health authority regulatory expectations.
• Perform additional responsibilities as assigned.

Required Knowledge, Skills, and Abilities

• >15 years management level experience with ability to develop staff.
• Excellent interpersonal and communication skills
• Ability to influence stakeholders and drive decision-making.
• Proficient in MS Office Software such as Excel, Word, Outlook and PowerPoint.
• Experience in MasterControl, eQMS, and eBR is a plus.
• Experience in Unicorn, Opti-Dry, Rockwell Studio is a plus.
• Knowledge of chemical engineering principles including reaction kinetics, reactor design, chemical thermodynamics, process modeling, heat, and mass transport a plus.
• Business acumen including experience with Asana, Smartsheet or Microsoft project or equivalent management tool and proven ability to learn and adapt to new systems
• Understanding and/or experience in chemical process scale-up and manufacturing of pharmaceuticals and/or biologics.
• Proven record of calm under pressure and a positive attitude.
• Highly organized.
• Ability to effectively collaborate.
• Outstanding communication skills (verbal and written).

Job Specifications

Education and Experience Requirements

Minimum of a Bachelor of Science (BS) in Chemical Engineering, Organic Chemistry, Process Chemistry or Physical Chemistry and a minimum of 15 years of experience within pharmaceutical, biotech or CDMO industries. GMP experience a plus.

Physical Demands
N/A

Working Conditions
Office environment with some lab/manufacturing environment

Certificates & Licenses Required
N/A