Lead/manage the manufacturing team on the floor in the clinical recombinant multiproduct and vaccine modality manufacturing suites
Support reporting supervisor in facility start up, construction and qualification of production equipment and processes
Lead/manage new pipeline candidates introduction into the manufacturing operations, including production changeover, equipment commissioning activities
Contribute to the Local Leadership Team of the clinical manufacturing pilot facility
Ensure production activities meet all GMP and compliance requirements and deploying agile approaches
Meet all department goals especially the production plan in quality and quantity
Drive improvement project implementation, supporting closure of CAPA, coach/ lead investigation of deviation trending, and optimize/ implement of single use and novel manufacturing technologies
Ensure functional organizational structure design capability that adapts to changing business needs with most support coming from contracted, external sources
Responsibilities:
Leading of the Upstream and Downstream manufacturing associates as well as Drug Product Fill and Finish operation
Responsible for manufacturing operations and fulfillment of all quality systems and policies
Ensure that the appropriate qualification and validations are done and that the production environment and storage areas are controlled and monitored for robust performance
Ensure that personnel is appropriately trained and qualified and the plant and equipment is maintained and fit for use
Responsible for the hiring and training of new workforce
Responsible for preparing and updating the functional budget and fulfillment of the budget targets
Responsible to ensure the fulfillment of all legal and EHS requirements
To represent the manufacturing functions in all internal and external audits
Ensure the continuous improvement of all processes and workflows to yield stable, lean and efficient manufacturing and business processes as well as an efficient and lean organization
Meet all functional goals especially the production plan in quality and quantity
Ensure the continuous improvement of all processes and workflows to yield stable, lean and efficient manufacturing and business processes as well as a efficient and lean organization
Coach and develop members of team to exemplify Hilleman Laboratories Core Values of Innovation, Integrity, Agility, Trust, Respect & Passion
Excellent trouble shooting and problem-solving skills
Thorough knowledge of current Good Manufacturing Practices (cGMP) and general
Technical and Vaccines and biologic understanding will be preferable
Business acumen
Cooperation and teamwork within a matrix environment
Qualifications:
Bachelors degree in Life Science or Engineering with more than 10 years of experience in manufacture of vaccines and therapeutic proteins (recombinant experience preferably)
Highly motivated to lead by example and passionate about Hilleman Laboratories Mission and Vision
Broad experience and understanding of regulatory guidelines
Demonstrated the ability to lead and to function in a collaborative/team-oriented production environment
Ability to communicate effectively and connect with all levels of the organization
Strong leadership and people management skills
Require excellent written/oral communication
Develop and nurture an organizational culture encompassing agility, innovation, trust, integrity, respect and collaborative spirit.
Impressive executive presence and engaging personality, with ability to interface professionally with key stakeholders, Board of Directors.
Team builder with a highly collaborative leadership style; ability to build / lead cohesive, high performing program teams.
Self-starter with a passion to achieve results with proven ability to generate high quality, on-time results.
