Director of Technical Services – Maryland
This position has primary responsibility for the site’s Bioscience MSAT department. The position is responsible for technology transfers, manufacturing support (investigations, change controls, CAPAs, process capability/capacity/efficiency/quality improvements) and process validation. Also, responsible for providing employee guidance; development and coaching to ensure the teams are aligned to the site strategy and are supporting the site to deliver on our current contracts and business pursuits. As a member of the site leadership team, advises on manufacturing-related issues, initiatives and strategy for continuous improve of site manufacturing performance and culture. Represents the BioScience MSAT organization during customer/manufacturing network meetings, audits and regulatory inspections.
- Performs all functions associated with leading the Bioscience MSAT organization. This includes a focus on safety, resource planning, oversight of the work deliverables, oversight of group budgetary performance, oversight of the team’s quality/compliance performance, providing guidance and advice on company policy and procedures, promoting global interactions, mediating conflicts, providing manufacturing and science technical input, customer/network/regulatory interaction, providing guidance on company/site strategy, prioritizing work and assisting in establishing long term group direction and objectives.
- Coaching and development of MSAT Team: Provides direct coaching, mentoring and development to each member of the MSAT management team both in execution of their group responsibilities and in their own personal development. Develops and coaches direct reports for future leadership roles. In addition, provide coaching and mentoring to every member of the MSAT organization for their personal and professional development
- Customer project interaction: Engage with program managers and directly with our customers to ensure projects are planned and executed appropriately in order to deliver to, and meet the needs of our customers and the business.
- Engage and Communicate with Site Leadership Team: Participate in site strategy decisions as a part of the site leadership team for the site. As a member of the site leadership team, lead cross-functionally with management, support departments, and customers to achieve site vision and strategy. Create a high-performance team that emphasizes strengths-based execution, accountability, open communication, people development and continuous improvement.
- Bachelor of Science degree in Biological Sciences or Biomedical/Chemical Engineering. Preferred: Masters in Science or Engineering or PhD.
- 15+ years of biotech, pharmaceutical or medical device industry experience in process development, process scale up/manufacturing and process validation.
- Experience with large scale manufacturing support for mammalian cell culture, aseptic final product filling/kitting/labeling, powder blending operations, liquid media manufacturing (vials, bags, bottles) and/or analytical reagent (e.g. endotoxin detection assay) manufacture, current Good Manufacturing Practices, US / EU regulations, and supervision.
- In depth knowledge of large scale biologic, pharmaceutical or medical device manufacturing, current Good Manufacturing Practices and US/EU regulations and intermediate knowledge of statistical data analysis. Knowledge should include a combination of cell biology, cell culture, scale up and mass transfer, media/buffer tank operation, liquid/solid formulation & compounding, virus/sterile filtration, aseptic processing technologies and include small scale (laboratory) experience.
- Strong leadership skills; strong communication, technical writing, organizational and interpersonal skills.
This global organization is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. They harness science and technology to create products that support safer and healthier living and that enhance the overall quality of life. Not only are they a custom manufacturer and developer, this company also offers services and a wide range of products to include active pharmaceutical ingredients, stem-cell therapies, organic personal care, and microbial control solutions that combat dangerous viruses, bacteria, and other pathogens. The company invests in quality workforce and the culture encourages the employees to challenge themselves and offer a work environment that fosters creativity and success. They have extensive benefits, competitive compensation, and opportunities for advancement.