Sr. Scientist, Drug Product Development (Job Code: TC0102)
TITLE:Sr. Scientist, Drug Product Development (Job Code: TC0102)
DUTIES:
Lead Flu Cell Culture (FCC) drug product development through life cycle management for important projects based in the FCC technology space including seasonal and pandemic products. Provide technical subject matter expertise in the drug product development space including formulation, process development, fill/finish, and delivery device design and selection for vaccine drug products. Author and provide input to technical documentation including study protocols, technical reports, product and process development plans, contract development and manufacturing proposals, and technical transfer plans. Represent Technical Development (TD) on project team(s) to provide program oversight and define detailed plans to tactically complete projects. Help develop strategies, plans, processes, and methods to ensure drug product and process development and process transfers. Use a data-driven approach for technical decision-making including risk assessment and mitigation. Collaborate with Technical Development leadership to create technical strategy for development of new drug products and life cycle management of legacy products. Provide technical oversight of product and process development activities sub-contracted to 3rd party development and manufacturing organizations. Promote culture of safety, ensures team follows requirements, and implement improvements. Use experience of drug product and fill/finish processes to provide technical support for production of drug product in GMP manufacturing. Use scientific and statistical knowledge to support product, process, and testing related investigations and deviations including complaint, deviation, OOE, and OOS investigations that require TD support. Promote safety compliance among colleagues in the laboratory. Produce high quality technical presentations for TD team members and other technical teams (e.g. MS&T). Maintain a state of compliance for team and self through regular review of training and implementing training curricula improvements. Provide project level leadership within TD and in project teams for formulation activities related to pipeline projects. Serve as an interface between TD and Operations and represent TD department in technical transfer forums to support manufacturing and QC. Provide ongoing performance feedback, technical guidance, and mentorship. Supervise 2 direct reports holding the positions of Scientific Technician and Scientist I. 5% domestic travel required to other Seqirus sites, vendors, or conferences as required. May work from home.
REQUIREMENTS:
Master’s degree (or foreign equivalent) in Chemical Engineering, Biomedical Engineering, or related field plus 5 years of experience in the offered position or related position.
SPECIAL REQUIREMENTS:
Must possess expertise/knowledge sufficient to adequately perform the duties of the job being offered.
Expertise/knowledge may be gained through employment experience or education. Such expertise/knowledge cannot be “quantified” by “time”. Required expertise/knowledge includes:
- Experience designing and implementing scientific strategy for drug product development to create therapeutics for clinical studies.
- Experience in biologics drug product development, including formulation, stability, fill/finish, analytical characterization, and delivery device design and selection.
- Knowledge of industry regulatory requirements and standards for submission of drug products for clinical and commercial development.
- Experience in the selection and management of sub-contracted 3rd party development and manufacturing organizations.
- Scientific background in relevant Life Sciences discipline particularly with emulsion chemistry, nanoparticle and microparticle characterization.
- Experience monitoring industry trends and procuring new technologies to improve current development platforms.
- Experience in developing business cases for new capital outlays (up to $200,000 USD).
- Experience in exploratory data analysis and statistical techniques including design of experiments.
- Experience authoring technical documentation including product and process development reports, regulatory CMC license sections, and presentations.
- Experience managing teams of individual technical contributors.
OTHER: Job Site: Summit, NJ. 40 hours/week; salary range: $135,990 per year to $150,000 per year. If offered employment must have legal right to work in U.S. EOE.
CONTACT: Seqirus Inc., Attn: Lou Fabri, 475 Green Oaks Pkwy, Holly Springs, NC 27540 (Reference Job Code: TC0102).
This notice is being provided as a result of the filing of a permanent alien labor certification application for this job opportunity. Any person may provide documentary evidence bearing on the application to: Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210
This position is eligible for Seqirus Inc.’s Employee Referral Program.
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