Manager, Drug Product

**Objectives**:
The incumbent will
- 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
- 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.
- Creative with strategic problem-solving skills.
- Strong multi-tasking and prioritization skills.