Associate Director/Director, Cell Therapy Manufacturing Ops job in Gaithersburg, USA

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Last Name*

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Job type: Permanent

Discipline: Senior/Director & VP, Good Manufacturing Practice (GMP), Good Clinical Practice (GCP)

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking a highly-motivated individual with cGMP cell therapy manufacturing experience to join a biotech that develops and manufactures active immunotherapies for patient-specific approaches to the treatment of diseases. This person would join the Clinical Manufacturing Operations Function at its Gaithersburg, Maryland (USA) site.

Job Responsibilities:

cGMP manufacture of cell therapy products for US clinical supply in accordance with clinical demand, turnaround requirements and budget
Maintenance of cGMP compliance and product quality through systematic control, analysis and continual improvement
Lead and Oversight of deviation remediation, investigations and corrective/preventative actions
Hands-on (boots-on-the-ground) management and development of manufacturing staff
Development and maintenance of master production records and standard operating procedures in support of manufacturing and equipment operations
Support production scheduling and capacity management
Support and drive cost of goods and turnaround time improvements
Own and lead Lean Tier structure
Provide weekly and monthly progress reports
Support the development and management of annual objectives, schedule and budget
Partner with Process Engineers and Process Development in the planning and execution of new product transfers and technology into manufacturing
Provide hands-on support, leadership and representation for site portfolio projects including facility GMP start-up, Tech Transfers and Site expansion

Skills and Requirements:

BS or MS in Biochemistry, Engineering or Life Science with 12+ years of cGMP manufacturing experience and 8+ years developing and supervising staff
Extensive experience and expertise in cGMP cell therapy (or biologics) and aseptic manufacture
Experience in mRNA, vector and/or peptide manufacture a plus
Expertise in process validation
Good working knowledge of CMC requirements in biopharmaceutical product development
Lean Black Belt certification a plus
Experience in preparing for and participating in regulatory inspections representing manufacturing, desired
Experience working with production planning, value chain improvements, materials management, QA, QC, and other functions directly involved in the manufacturing of biopharmaceutical products.
Strong leadership, risk management and project management skills
Function building and staff development experience
Expertise in problem solving and leading investigations
Excellent communication, interpersonal and collaboration skills. Demonstrated experience and ability to work within cross-functional teams within a site and globally.
Attention to detail and well organized
High energy level and a positive outlook coupled with the requisite "can do" attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
Willingness to think outside of the box and adapt best practices in a constantly evolving environment
Self-motivated with a strong sense of ownership and accountability in areas of responsibility

If you are having difficulty in applying or if you have any questions, please contact Eloise Coly at (+1) 617-830-1627 or E.Coly@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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