Director, Manufacturing

Location
Gaithersburg, MD
Posted
Oct 07, 2021
Ref
2021-1564
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time

Exciting opportunity for experienced manufacturing leader to join a clinical-stage biotech company developing innovative bacteriophage therapies addressing the global crisis of antibiotic-resistant bacterial infections. 

 

The Director, Manufacturing will be a member of the operations senior leadership team charged with leading, growing and developing the Manufacturing Department.  Key responsibilities will include hiring and training members of the team, producing GMP bacteriophage batches and assisting in qualification of new GMP manufacturing facilities.  The successful candidate will have experience in a variety of upstream manufacturing and downstream purification processes, expertise in preparing and managing operating plans and budgets for GMP facilities, and a thorough understanding the requirements of operations in a GMP environment.  The Director will work closely with Quality and Process Development leadership, represent Manufacturing in cross-functional teams and to Executive Management and be the lead, technical point of contact for any outsourced manufacturing activities. 

Responsibilities

  • Develop and implement the Department's strategy, ensuring it meets right-sized compliance requirements, business requirements, and customer deliverables, as well as ensuring the Department meets performance goals
  • Ensure the development and implementation of Department SOPs/protocols/specifications (writing, revising, and approving) to ensure compliance to regulatory/business/customer requirements in conjunction with being “fit for purpose” operationally
  • Hire, develop, and retain Manufacturing personnel (including temporary, contract, and/or consultant staff) to maintain a high-performing credible team while ensuring that all staff maintain appropriate levels of training
  • Develop and ensure a culture of strong GMP compliance
  • Develop and track Department budget
  • Manage all production activities and establish robust operations and scheduling systems that maximize use of facility and staff
  • Ensure that production facilities are maintained at a high standard of cleanliness and organization, equipment maintenance and calibrations are performed and GMP documentation is completed and reviewed in a timely manner
  • Identify and serve as the technical point of contact for outsourced vendors

Qualifications

  • Highly refined leadership and influencing abilities
  • Ability to understand and assess a wide variety of manufacturing issues while identifying innovative approaches and solutions to problems in a highly flexible and interactive manner as new information is revealed or requirements evolve or change
  • Excellent communication skills with demonstrated ability to interact with and build relationships at many levels of organizations to accomplish objectives
  • Ability to resolve conflict effectively
  • Skill in building and maintaining cross functional relationships
  • Ability to manage multiple priorities with a sense of urgency to meet timelines
  • Adaptability to change
  • Working knowledge of USA and global regulations for GMP manufacturing of drug substances and drug products including requirements for clinical phase appropriate validation/qualification
  • Demonstrated skill with quality management systems (e.g. Deviations, CAPAs, Change Management)
  • Ability to conduct technology transfers (e.g., from internal partners or academic institutions or to a third-party contract manufacturing organization)
  • Bachelor of Science degree / equivalent in life sciences or related field
  • 10+ years of experience in the pharmaceutical and biotechnology industries5+ years supervisory experience in industry with demonstrated success in building a manufacturing team
  • Fluency with regularly used Microsoft software applications (Word, Excel, PowerPoint, SharePoint)
  • Experience in microbiology and virology preferred
  • Experience with government contracting desired
  • Experience in design, qualification, and start-up of manufacturing facilities preferred

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