VP, Manufacturing/ Technical Operations

Job Responsibilities:

The Vice President, Manufacturing/ Technical Operations (MTO) will be responsible for developing NJ Bio's strategic manufacturing/technical start-up operations roadmap, which also includes activities that support Good Manufacturing Practices (GMP). These activities include production operations, facility, capital engineering (commissioning, equipment, facility buildout/expansion), process engineering (manufacturing sciences and technology (MSAT), qualification/validation, technical operations, EHS, and warehouse management and maintenance. This individual will engage and develop the MTO team and explore technical partnerships with academic and other organizations/institutions to stay at the forefront of manufacturing technologies. The candidate is expected to roll up their sleeves to perform or implement policies, procedures and strategies as required by operations. The incumbent works cross-functionally with internal departments and external resources on manufacturing/ technical operations related issues. The VP, Manufacturing/ Technical Operations accountable for adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

• Lead, develop, implement, and execute a global manufacturing strategy that is aligned with NJ Bio’s expectations to provide high-quality clinical supplies to clients.
• Build, develop, and lead a department that has the capability to manufacture multiple active pharmaceutical products (API) including high-potent APIs (HPAPI), mRNAs, drug substances (DS), and Antibody Drug Conjugates (ADCs) following GMP standards.
• Oversee, and as required, perform and implement all the activities that support the manufacturing of GMP materials such as facility, capital engineering (commissioning, equipment, facility buildout/expansion), process engineering (manufacturing sciences and technology (MSAT), qualification/validation, master validation plan, warehouse management and maintenance.
• Oversee/implement the department's finalization of manufacturing campaigns and engineering projects.
• Develop short- and long-term technical objectives for the organization that cover manufacturing and engineering.
• 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.
• Contribute to evaluating customer/partnership at an early stage.
• Work with senior leadership to evaluate customers/clients and recommend decision on manufacturing capability and assist in pricing for services.
• Serve as the technical (manufacturing and engineering) lead for manufacturing partnerships/collaboration.
• Serve as the technical operations (manufacturing and engineering) due diligence lead for business development activities.
• 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.
• Maintain the operational facility at a high level of cGMP compliance per FDA, EMEA and customer expectations.
• Ensure that all operations are always compliant with EHS Standards and OSHA and EPA requirements.
• Promote and ensure a safety culture with areas of responsibility.
• Manage, coach, and mentor direct reports.
• Perform other tasks and assignments as needed and specified by management.

Requirements:

Required Knowledge, Skills and Abilities:

• Strong background in manufacturing multiple active pharmaceutical and biologic products (API) including high-potent APIs (HPAPI), mRNAs, drug substances (DS), and Antibody Drug Conjugates (ADCs)
• Hands-on experience working in GMP environment and clinical manufacturing
• Leadership experience of teams is required.
• Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
• Ability to influence without direct authority
• Proficiency with Microsoft Office
• Excellent verbal and written communication skills as well as interpersonal skills.
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil the business need.

Education and Experience Requirements:

• BS, MS, or PhD degree in chemistry, biology, biochemistry, engineering or related discipline.
• 10 years of experience in a GMP manufacturing or CRO setting and leadership experience required.

Physical Demands:

• Requires standing and walking.
• Occasionally requires lifting of up to 20 pounds.
• Requires manual dexterity and visual abilities.

Working Conditions:

Office based position with ability to occasionally work in laboratory.

NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.