Title: VP, Product Development
Location: Miami, Florida
Longeveron LLC is an emerging biotechnology company whose mission is to advance the field of regenerative medicine through the conduct of clinical trials of novel stem cell products. We are striving to improve and expand our technologies and product lines to meet the increasing needs of the biomedical community with a focus on biological solutions for aging.
We are seeking a dynamic and experienced senior scientist to grow with our team to lead the product development team to innovate and develop new cell therapeutic products for commercial and research applications that meet the growing market needs. This position is based at Longeveron headquarters in Miami, Florida in our newly constructed, state-of-the-art manufacturing facility.
- Oversee all human and animal product development and manufacturing of cell based therapeutic products for domestic and international programs.
- Manage continuing validation and operations of cGMP manufacturing facility.
- Develop and implement scale-up/optimization methods for cell production to ensure maximum throughput.
- Guarantee safe, compliant and manageable cGMP operations.
- Maintain all required SOPs and materials per cGMP and FDA regulations.
- Prepare and administer manufacturing and development budgets.
- Execute metrics to track and maintain successful accomplishments of assigned goals, objectives, and projects in a timely manner.
- Drive concepts and plans into detailed requirements, clear priorities, execution, and successful launch of the products. Manage current product lines and inventory to meet product demands.
- Ensure appropriate testing and analysis procedures are implemented to maintain FDA standards.
- Assist with oversight of clinical studies for compliance with all applicable FDA regulations.
- Recommend the nature and scope of present and future product lines by reviewing product specifications and requirements; appraising new product ideas and/or product or packaging changes.
- Assess market competition by comparing the company’s product to competitors’ products.
- Provide information for management and sales & marketing teams by preparing short-term and long-term product development strategies.
- Facilitate inventory turnover and product availability by reviewing and adjusting inventory levels and production schedules.
- Assist with bringing products to market by analyzing proposed product requirements and product development programs; preparing return-on-investment analyses; establishing time schedules with manufacturing.
- Complete operational requirements by scheduling and assigning employees; following up on work results.
- Maintain product management staff by recruiting, selecting, orienting, and training employees.
- Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
- Assist with grant and related medical writing.
- Contribute to team effort by accomplishing related results as needed.
Required Knowledge, Skills and Education:
- Ph.D. Chemistry, Biology, Bioengineering, Biopharmaceuticals, or a related field or substitute work experience in Aseptic Manufacture of Drugs and/or Biologics.
- 5-plus years of experience direct overseeing cGMP production activities in a for-profit, commercial entity. Specific experience overseeing manufacture of aseptic biologic/drug products for commercial market required.
- Expertise leading a team in aseptic Cell Culture and hands on experience in bench scale cell culturing.
- Demonstrated ability to perform scale up of processes to ensure proper cell banking and culture expansion.
- 5-plus years of experience managing, training and mentoring team of scientists, engineers and technicians in commercial cell cGMP production laboratory facility.
- Experience drafting relevant manufacturing portions including processing methods, quality control and process validations as components of INDs and BLAs.
- Applied skills in cost analysis and development of cost improvement strategies to support the life cycle of products in manufacturing.
- Knowledge of and ability to interpret and apply regulatory requirements as they relate to Biologics Manufacturing and Product Quality Control.
- Effective written and oral communication skills, and presentation skills.
- Ability to independently review and understand project proposals/plans
- Accountable, organized, detail-oriented, and passionate on taking on new projects.
- Team-player – Must work well with a wide spectrum of groups, including R&D, service, and management teams.
- Strong communication skills– Must think through complex, technical details and summarize them in clear terms that are easily digested by a less-technical audience.
Longeveron LLC is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
Life Science & Technology Park, 1951 NW 7th Avenue, Suite 520, Miami, Florida 33136
Contact: Suzanne Page email@example.com