Objectives:

The incumbent will:

• Drive the formulation and product development strategies of Hilleman Laboratories pipeline products (including vaccines, mAbs, recombinant proteins).
• Manage the Drug Product (DP) manufacturing team in qualification of the necessary production equipment and processes.
• Lead the DP manufacturing team in managing new pipeline candidate introduction into the manufacturing operations, including production changeover, equipment commissioning activities.
• Meet all department goals especially the development and tech transfer plans in quality and quantity.
• Support GMP-driven improvement project implementation, closure of CAPA, coach/lead investigation of deviation trending, and optimize/implement of single use and novel manufacturing technologies related to Drug Product; and
• Manage the DP manufacturing team to ensure functional organizational structure design capability that adapts to changing business needs with most support coming from contracted, external sources.
• Manage a high performing team and provide creative strategies to maximize team engagement and ensure team reaches full potential.

Responsibilities:

• Oversee a team responsible for formulation and drug product development and operations for Recombinant protein, Mab and vaccines portfolio for process scale-up and manufacturing for clinical trials
• Collaborating with Process Development, Analytical Development, Quality Control, Quality Assurance, Regulatory, Clinical Supply Manufacturing and also interface with external contract organizations as required.
• Identify and implement innovative solutions and technologies to resolve complex problems and drive continuous improvement in drug product development.
• Serve as member of the CMC/GMP leadership team and extended Process Development leadership team utilizing network thinking and innovative approaches to advance the drug product organizational capabilities
• Providing technical expertise in execution of vaccines and biologics product formulation development - including new formulation modalities, clinical drug product process development/engineering and clinical drug product manufacturing.
• Designing and executing phase-appropriate (from discovery till Phase-2 clinical development), robust DP formulation development, process development, process characterization, and process validation studies, and if necessary, with manufacturing partners.
• Guide the execution of formulation and drug product development strategies, coach the authoring and review of technical protocols, design and lead experimentation, review technical reports, and coach authoring and review related CMC sections to support regulatory submissions and responses.
• Representing formulation science and drug product development within cross-functional project teams.
• Executing development of project strategy and communicating complex data/decisions within department and cross-functionally as necessary.
• Supporting local leadership team in hiring and training of new workforce.
• Preparing and updating the functional budget and fulfillment of the budget targets.
• Supporting formulation development and drug product manufacturing to ensure the fulfillment of all legal and EHS requirements.
• Supporting the drug product manufacturing function in all internal and external audits.
• Ensuring 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.
• Coaching and developing members of team to exemplify Hilleman Laboratories Core Values of Innovation, Integrity, Agility, Trust, Respect & Passion.

Qualifications:

Must have:

• Master/PhD degree in Chemistry, Biology, Pharmacy, Engineering or related Pharmaceutical Sciences and minimum 10 years of relevant industry experience.
• Minimum 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
• Experienced and demonstrated track record in CMC biopharmaceutical development including, but not limited to, drug product development, drug product process characterization, QbD, control strategy, and validation under cGMP environment.
• Sound knowledge of current Good Manufacturing Practices (cGMP);
• Experience in working in a multi-disciplinary team environment.
• Sound knowledge of laboratory safety practices and standard operating procedures.
• Broad experience and understanding of regulatory guidelines.
• Strong verbal/written communication to communicate effectively and connect with all levels of the organization.
• Strong technical, organizational, interpersonal and leadership skills.

Highly Desirable:

• Previous experience with the use of contract facilities.
• Familiarity with current applicable scientific literature and applicability to various projects.
• Excellent trouble-shooting and problem-solving skills;
• Ability to investigate and develop new processes and technologies for project advancement;
• Well-organized and detail oriented, with ability to effectively prioritize tasks, eager to learn, interact cooperatively and effectively with others in a team environment, and consistently demonstrate reliability and responsibility;
• Experience in lyophilization and/or combination drug product development with good understanding of the inter-relationship among formulation parameters, process parameters, device performance, product delivery, and quality.
• Demonstrated ability to lead and to function efficiently in a collaborative/team-oriented production environment.

Desirable:

• Good understanding of protein degradation and stabilization strategies.
• Good understanding of CMC management with involved function areas to drive and meet deliverables in the matrix environment and cross-functional improvements;
• Experience with Statistics and Design of Experiment (DoE) as applied in an applied research and development as well as industrial biopharmaceutical environment;
• Impressive executive presence and engaging personality, with ability to interface professionally with key stakeholders, Board of Directors;
• Ability to critically evaluate results and ability to defend strategic guidance to resolve technical issues.
• Self-starter with a passion to achieve results with proven ability to generate high quality, on-time results.