Plans, directs, and executes product formulation & process development activities in support of development of new products intended for clinical trials and commercialization with focus on neurotoxin and biologic drug products. Conducts research in the area of formulation sciences in support of innovative product development both for new biologic entities and life-cycle management of marketed products.
The essential components of this position are in-depth understanding of pharmaceutical formulation principles, manufacturing process unit operations, global CMC regulatory requirements as well as strong organizational skills to develop formulations intended for clinical trials and commercialization. Specifically,
- Provide scientific and technical leadership for product formulation development projects and in general, Pharmaceutical Sciences. Applies the principles of quality by design (QbD) and statistical process design/analysis to formulation and process development.
- Demonstrate scientific excellence through scientific reports, published articles in peer-reviewed journals, society participation, regulatory filings, and/ or patents.
- Represent department at CMC/Project Team meetings and work closely with other Pharmaceutical Sciences departments, Toxicology, Regulatory Affairs, Quality, Clinical Development and Marketing to meet project timelines and objectives.
- Apply current CMC regulatory requirements and guidance to support global registration of new products.
- Exhibit leadership skills that result in good performance and career development of junior staff.
- Keeps abreast of current developments in pharmaceutical technology, leading edge technologies and regulatory affairs to contribute to the technical base.
- Have excellent communication (oral and written) and interpersonal skills.
KEY DUTIES AND RESPONSIBILITIES
Primary focus: Plans, directs, and executes drug product formulation & manufacturing process development activities in support of development of new neurotoxin and biologic products intended for clinical trials and commercialization. The incumbent will design and execute formulation studies to optimize solution conditions, such as pH, concentration, excipients, and other parameters to sufficiently stabilize biologic molecules for use in human clinical trials. This individual will propose phase appropriate formulation strategies and drug product development plans that align with overall project goals, that range from supporting pre-clinical / phase 1 studies to developing products for phase 3 / commercial launch. This incumbent will identify and develop drug product manufacturing processes which may require bulk biological drug substance freeze/thaw, liquid mixing, sterile filtration, container filling, visual inspection, as well as transportation / cold chain management. The incumbent will technology transfer drug product manufacturing process to domestic and international sites, including the identification, design, and execution of at-scale process studies, as well as developing and ensuring adherence to project schedules. The Senior Scientist I will design and scale-up lyophilization processes for clinical and commercial production, including cycle optimization, robustness studies, and technology transfer. The incumbent will utilize ICH Quality by Design methodologies such as risk assessments, Target Product Profiles, and Critical Parameters to ensure appropriate design space, control points, and in-process specifications are established. The incumbent will author technical documents including manufacturing records, formulation development & technology transfer reports, and CMC sections of IND, IMPD, BLA submissions. The Senior Scientist I, Neurotoxin & Biologics Product Development will represent functional area at project team meetings and work closely with cross-functional team members to develop the overall CMC strategy, identify critical path activities and timelines, as well as ensure coordinated project execution.
The position requires the individual to work with and in areas requiring select agents and toxins access (i.e. Biosafety level 2 and biosafety level 3 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives.
Provides scientific and technical leadership on one or more areas of formulation development and dosage form design. Develops and maintains a current in-depth knowledge of global CMC regulatory submission requirements and GLP/GMP requirements. Review internal and external technical documents, writes technical memos/reports, patents, and scientific articles.
Represents department at CMC/project team meetings and work closely with other Pharmaceutical Sciences departments, Toxicology, Regulatory Affairs, Quality, Clinical Development and Marketing to meet project timelines and objectives.
Performs supervisory duties including reviewing progress of assignments against established project timelines, assistance on daily work direction, problem solving and advice to junior staff to enhance their work effectiveness in generating data, ensuring good record keeping of all laboratory data, adherence to lab safety and general staff development.
Education and Experience
This position requires a Ph.D. level education in pharmaceutical sciences, biochemical/chemical engineering, biology, chemistry or other related scientific with 4+ years of applicable experience or a MS degree in pharmaceutical sciences, biochemical/chemical engineering, biology, chemistry or other related scientific with 10+ years of applicable experience.
Must be able to operate as a functional area leader and utilize knowledge of pharmaceutical science literature and experience to guide decisions in complex situations. Knowledge of fundamental applications of statistics is preferred.