Director of Clinical Manufacturing Operations
Location : Mahwah NJ US 07430
Job Type : Direct
Reference Code : 20850-AB1
Compensation : 155000.00 - 195000.00 USD/YEAR
Start Date : 01/14/2022
Hours : Full Time
Required Years of Experience : 10
Required Education : BS Life Science
Travel : No
Relocation : No
Job Industry : Pharmaceutical
Job Description :
- Permanent position for a Director of Clinical Manufacturing Operations to manage the department’s day to day operations to ensure safe, quality, and timely manufacturing of client biopharmaceutical products for pre-clinical, clinical, and commercial use.
- Interact with clients, provide strong technical leadership and collaborate effectively across groups within the organization.
- Lead the organization into a data driven, team-oriented culture that embraces continuous improvement and drives quality, supply, and financial performance of the Clinical Manufacturing Operations team.
- Responsible for business development activities, including development of operations resource models and input into generating prospective / existing client proposals, manufacturing service agreement (MSA) and scope of work (SOW).
- Execute agreements ensuring both client expectations are met and agreed upon for the profitability and success of the project.
- Serve as a Site Leadership Team member providing comprehensive leadership to promote a positive work environment and communicate overall business expectations.
- Lead all site Production Planning, ensuring all production operations are controlled and executed within GMP regulatory guidelines.
- Develop and implement facilities policies and practices (SOPs).
- Deliver departmental goals and objectives based on compliance, milestones, and revenue targets.
- Accountable for the tracking, trending, and improvement of the Operations KPIs, driven by cost-effective and efficient output of client’s products
- Provide strategic direction and set objectives to meet financial and operational requirements that are aligned with site and regional targets.
- Work directly with internal and external stakeholders on projects of existing and prospective clients to ensure appropriate capacity, improve quality, adequate sourcing of critical deliverables
- Work directly with Quality Assurance, Quality Control, MSAT, Project and Account Management and Manufacturing Support groups to ensure smooth tech transfer of client-sponsored projects and site and corporate goals are met.
- Ensure all Operations processes and procedures are in full accordance with GMP, CFR, site quality systems, company policies and promote a culture of quality, compliance, and excellence.
Required Qualifications :
- BS degree in a life science, MS degree preferred.
- Minimum 10 years of experience in a pharmaceutical or biotech manufacturing GMP regulated facility.
- Minimum 2 years of experience in cell processing, cell culture, cell analytics, and related GMP technologies for cell therapy product manufacturing.
- Experience with autologous and/or allogeneic cell therapy manufacturing processes is preferred.
- Extensive practical experience with GMP quality systems and procedures.
- Experience in strategic planning, process improvement, project execution, and data/business analytics.
- Understanding of the technical principles, theories, and concepts of low complexity technology transfer and the manufacturing of cell therapy or similar products.
- Excellent oral and written communication, collaborative, presentation, and influencing skills with strong business acumen, integrity, authenticity, and a growth mindset.
- Detailed knowledge of manufacturing technology, industry trends and requirements associated with the introduction of new equipment and methods into a manufacturing setting.
- Recognized skills for ability to develop efficient operations with robust processes and implementation of operational KPIs focused on Right First Time and On-time delivery.
Contact: Allan Berman
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