Involve in the formulation and product development of Hilleman Laboratories pipeline products (including vaccines, mAbs, recombinant proteins);
Support in managing the manufacturing (GMP) team on the floor in the clinical recombinant multiproduct and vaccine modality manufacturing suites;
Support the manufacturing team in facility start up, construction and qualification of Drug Product production equipment and processes;
Support the manufacturing team in managing new pipeline candidate introduction into the manufacturing operations, including production changeover, equipment commissioning activities;
Support the Local Leadership Team in managing clinical manufacturing pilot facility;
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 trends, and optimize/implement single use and novel manufacturing technologies related to Drug Product; and
Support the manufacturing team to ensure functional organizational structure design capability that adapts to changing business needs with most support coming from contracted, external sources.
Responsibilities:
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 until Phase-2 clinical development), robust DP formulation development, process development, process characterization, and process validation studies, and if necessary with manufacturing partners;
Driving the execution of formulation and drug product development strategies, author technical protocols, design and implement experimentation, generate technical reports, and author related CMC sections to support regulatory submissions and responses;
Collaborating with Process Development, Analytical Development, Quality Control, Quality Assurance, and also interface with external contract organizations as required;
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 fulfilment of the budget targets;
Supporting formulation development and drug product manufacturing to ensure the fulfilment 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; and
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;
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) in an applied research and development and 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 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.
